Trial Outcomes & Findings for A Dose Escalation Study of a Combination Antihypertensive Drug in the Treatment of Various Groups of Patients Who do Not Respond to Single Drug Treatment of Their High Blood Pressure (NCT NCT00791258)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

999 participants

Primary outcome timeframe

baseline to 12 weeks

Results posted on

2019-01-09

Participant Flow

Recruitment occurred at approximately 140 outpatient medical clinics in the United States and South Africa from December 2008 through March 2009. 1406 uncontrolled hypertensive subjects were screened to place 999 subjects into active treatment.

Participant milestones

Participant milestones
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Overall Study STARTED	999
Overall Study COMPLETED	736
Overall Study NOT COMPLETED	263

Reasons for withdrawal

Reasons for withdrawal
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Overall Study Adverse Event	87
Overall Study Lost to Follow-up	18
Overall Study Protocol Violation	109
Overall Study Withdrawal by Subject	40
Overall Study Did not take medication for >3 days	1
Overall Study subject left area	2
Overall Study non-compliance	3
Overall Study Subject incarcerated	1
Overall Study Subject required restricted medication	1
Overall Study Lack of Efficacy	1

Baseline Characteristics

A Dose Escalation Study of a Combination Antihypertensive Drug in the Treatment of Various Groups of Patients Who do Not Respond to Single Drug Treatment of Their High Blood Pressure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=999 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	771 Participants n=93 Participants
Age, Categorical >=65 years	228 Participants n=93 Participants
Sex: Female, Male Female	491 Participants n=93 Participants
Sex: Female, Male Male	508 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	6 Participants n=93 Participants
Race (NIH/OMB) Asian	129 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	234 Participants n=93 Participants
Race (NIH/OMB) White	630 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	732 participants n=93 Participants
Region of Enrollment South Africa	267 participants n=93 Participants
Hispanic or Latino Hispanic or Latino	105 Participants n=93 Participants
Hispanic or Latino Non-Hispanic or Latino	894 Participants n=93 Participants
Type 2 Diabetes Yes	192 Participants n=93 Participants
Type 2 Diabetes No	807 Participants n=93 Participants
Weight	88.20 kg STANDARD_DEVIATION 21.466 • n=93 Participants
Body Mass Index	31.02 Kg/m٨2 STANDARD_DEVIATION 6.370 • n=93 Participants
Metabolic syndrome Yes	462 Participants n=93 Participants
Metabolic syndrome No	537 Participants n=93 Participants
Mean seated systolic blood pressure	153.66 mm Hg STANDARD_DEVIATION 9.178 • n=93 Participants
Mean seated diastolic blood pressure	91.92 mm Hg STANDARD_DEVIATION 8.616 • n=93 Participants
Pulse rate	74.77 beats/minute STANDARD_DEVIATION 11.621 • n=93 Participants
24-Hour mean systolic ambulatory blood pressure	135.74 mm Hg STANDARD_DEVIATION 11.698 • n=93 Participants
24-Hour mean diastolic ambulatory blood pressure	81.09 mm Hg STANDARD_DEVIATION 9.346 • n=93 Participants

PRIMARY outcome

Timeframe: baseline to 12 weeks

Population: The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=985 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
The Percentage of Patients Who Achieve Seated Systolic Blood Pressure Goal (<140 mm Hg for Non-diabetics and <130 mm Hg for Diabetics) From Baseline to 12 Weeks	75.8 Percentage of participants

SECONDARY outcome

Timeframe: baseline to 12 weeks

Population: The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=985 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
The Percentage of Subjects Achieving Seated Diastolic BP Goal (<90 mmHg for Non-diabetics or < 80 mmHg for Subjects With Diabetes) From Baseline to 12 Weeks	84.3 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to 12 and 20 weeks

Population: The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=985 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
The Percentage of Subjects Who Achieve BP Goal (<140/90 mmHg for Non-diabetics or <130/80 mmHg for Diabetics) From Baseline to 12 and 20 Weeks 12 weeks	71.3 Percentage of participants
The Percentage of Subjects Who Achieve BP Goal (<140/90 mmHg for Non-diabetics or <130/80 mmHg for Diabetics) From Baseline to 12 and 20 Weeks 20 weeks	84.8 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Population: The analysis population consists of those participants who have a baseline and at lease 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=975 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Change in Mean Seated Systolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks, N=975	-14.6 mm Hg Standard Error 0.42
Change in Mean Seated Systolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks, N=929	-16.6 mm Hg Standard Error 0.46
Change in Mean Seated Systolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks, N=865	-21.8 mm Hg Standard Error 0.46
Change in Mean Seated Systolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks, N=797	-26.0 mm Hg Standard Error 0.51
Change in Mean Seated Systolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks, N=745	-26.8 mm Hg Standard Error 0.53

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Population: The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=975 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Change in Mean Seated Diastolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks, N=975	-8.1 mm Hg Standard Error 0.27
Change in Mean Seated Diastolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks, N=929	-9.1 mm Hg Standard Error 0.29
Change in Mean Seated Diastolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks, N=865	-11.9 mm Hg Standard Error 0.28
Change in Mean Seated Diastolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks, N=797	-14.6 mm Hg Standard Error 0.31
Change in Mean Seated Diastolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks, N=745	-14.5 mm Hg Standard Error 0.34

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Population: The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=975 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <90 mm Hg, N=975	71.3 Percentage of participants
Percentage of Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4weeks: <85 mm Hg, N=975	55.2 Percentage of participants
Percentage of Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <80 mm Hg, N=975	34.2 Percentage of participants
Percentage of Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <90 mm Hg, N=929	75.1 Percentage of participants
Percentage of Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <85 mm Hg, N=929	57.1 Percentage of participants
Percentage of Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <80 mm Hg, N=929	40.2 Percentage of participants
Percentage of Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <90 mm Hg, N=865	84.3 Percentage of participants
Percentage of Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <85 mm Hg, N=865	68.7 Percentage of participants
Percentage of Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <80 mm Hg, N=865	49.5 Percentage of participants
Percentage of Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <90 mm Hg, N=797	90.2 Percentage of participants
Percentage of Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <85 mm Hg, N=797	76.9 Percentage of participants
Percentage of Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <80 mm Hg, N=797	59.6 Percentage of participants
Percentage of Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <90 mm Hg, N=745	89.7 Percentage of participants
Percentage of Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <85 mm Hg, N=745	79.5 Percentage of participants
Percentage of Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <80 mm Hg, N=745	62.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Population: The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=975 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <140 mm Hg, N=975	54.2 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <135 mm Hg, N=975	39.8 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <130 mm Hg, N=975	25.3 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <120 mm Hg, N=975	8.9 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <140 mm Hg, N=929	57.2 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <135 mm Hg, N=929	45.9 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <130 mm Hg, N=929	35.0 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <120 mm Hg, N=929	12.9 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <140 mm Hg, N=865	72.6 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <135 mm Hg, N=865	59.0 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <130 mm Hg, N=865	45.3 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <120 mm Hg, N=865	19.4 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <140 mm Hg, N=797	80.9 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <135 mm Hg, N=797	70.3 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <130 mm Hg, N=797	58.9 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <120 mm Hg, N=797	30.9 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <140 mm Hg, N=745	84.3 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <135 mm Hg, N=745	75.2 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <130 mm Hg, N=745	64.2 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <120 mm Hg, N=745	31.5 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Population: The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=975 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <140/90 mm Hg, N=975	49.1 Percentage of Participants
Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <135/80 mm Hg, N=975	23.0 Percentage of Participants
Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <130/80 mm Hg, N=975	17.3 Percentage of Participants
Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <120/80 mm Hg, N=975	7.8 Percentage of Participants
Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <140/90 mm Hg, N=929	52.4 Percentage of Participants
Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <135/80 mm Hg, N=929	29.8 Percentage of Participants
Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <130/80 mm Hg, N=929	24.8 Percentage of Participants
Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <120/80 mm Hg, N=929	11.2 Percentage of Participants
Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <140/90 mm Hg, N=865	68.1 Percentage of Participants
Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <135/80 mm Hg, N=865	40.0 Percentage of Participants
Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <130/80 mm Hg, N=865	34.3 Percentage of Participants
Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <120/80 mm Hg, N=865	17.6 Percentage of Participants
Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <140/90mm Hg, N=797	77.8 Percentage of Participants
Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <135/80mm Hg, N=797	51.3 Percentage of Participants
Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <130/80mm Hg, N=797	46.2 Percentage of Participants
Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <120/80mm Hg, N=797	28.7 Percentage of Participants
Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <140/90 mm Hg, N=745	81.3 Percentage of Participants
Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <135/80 mm Hg, N=745	55.6 Percentage of Participants
Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <130/80 mm Hg, N=745	50.1 Percentage of Participants
Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <120/80 mm Hg, N=745	28.2 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Population: The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=975 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >45 mm Hg, N=797	8.9 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: ≤ 15 mm Hg, N=975	51.4 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >15 and ≤ 30 mm Hg, N=975	36.6 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >30 and ≤ 45 mm Hg, N=975	10.5 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >45 mm Hg, N=975	1.5 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: ≤ 15 mm Hg, N=929	45.8 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >15 and ≤ 30 mm Hg, N=929	37.7 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >30 and ≤ 45 mm Hg, N=929	14.3 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >45 mm Hg, N=929	2.3 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: ≤ 15 mm Hg, N=865	30.5 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >15 and ≤ 30 mm Hg, N=865	43.1 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >30 and ≤ 45 mm Hg, N=865	22.4 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >45 mm Hg, N=865	3.9 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: ≤ 15 mm Hg, N=797	23.2 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >15 and ≤ 30 mm Hg, N=797	35.9 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >30 and ≤ 45 mm Hg, N=797	32.0 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: ≤ 15 mm Hg, N=745	20.4 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >15 and ≤ 30 mm Hg, N=745	36.2 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >30 and ≤ 45 mm Hg, N=745	34.0 Percentage of Participants
Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >45 mm Hg, N=745	9.4 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Population: The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=975 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: ≤ 10 mm Hg, N=975	61.3 Percentage of Participants
Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >10 and ≤ 15 mm Hg, N=975	21.0 Percentage of Participants
Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >15 and ≤ 20 mm Hg, N=975	10.5 Percentage of Participants
Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >20 mm Hg, N=975	7.2 Percentage of Participants
Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: ≤ 10 mm Hg, N=929	54.7 Percentage of Participants
Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >10 and ≤ 15 mm Hg, N=929	20.7 Percentage of Participants
Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >15 and ≤ 20 mm Hg, N=929	14.1 Percentage of Participants
Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >20 mm Hg, N=929	10.6 Percentage of Participants
Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: ≤ 10 mm Hg, N=865	43.8 Percentage of Participants
Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >10 and ≤ 15 mm Hg, N=865	24.1 Percentage of Participants
Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >15 and ≤ 20 mm Hg, N=865	15.8 Percentage of Participants
Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >20 mm Hg, N=865	16.3 Percentage of Participants
Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: ≤ 10 mm Hg, N=797	30.4 Percentage of Participants
Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >10 and ≤ 15 mm Hg, N=797	22.8 Percentage of Participants
Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >15 and ≤ 20 mm Hg, N=797	21.5 Percentage of Participants
Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >20 mm Hg, N=797	25.4 Percentage of Participants
Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: ≤ 10 mm Hg, N=745	31.4 Percentage of Participants
Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >10 and ≤ 15 mm Hg, N=745	19.9 Percentage of Participants
Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >15 and ≤ 20 mm Hg, N=745	22.6 Percentage of Participants
Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >20 mm Hg, N=745	26.2 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 12 week ABPM data.

Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8AM - 4PM.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=229 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks Daytime mean diastolic blood pressure <85 mmHg	83.0 Percentage of participants
Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks Daytime mean diastolic blood pressure <80 mmHg	65.5 Percentage of participants
Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks Daytime mean blood pressure <140/90 mmHg	86.9 Percentage of participants
Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks Daytime mean blood pressure <135/95 mmHg	72.9 Percentage of participants
Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks Daytime mean blood pressure <135/80 mmHg	61.1 Percentage of participants
Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks Daytime mean blood pressure <130/80 mmHg	53.3 Percentage of participants
Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks Daytime mean blood pressure <125/75 mmHg	31.9 Percentage of participants
Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks Daytime mean blood pressure <120/80 mmHg	27.9 Percentage of participants
Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks Daytime mean blood pressure <120/70 mmHg	13.1 Percentage of participants
Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks Daytime mean systolic blood pressure <140 mmHg	88.2 Percentage of participants
Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks Daytime mean systolic blood pressure <135 mmHg	79.9 Percentage of participants
Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks Daytime mean systolic blood pressure <130 mmHg	66.4 Percentage of participants
Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks Daytime mean systolic blood pressure <120 mmHg	28.8 Percentage of participants
Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks Daytime mean diastolic blood pressure <90 mmHg	95.6 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to 20 weeks

Population: Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 20 week ABPM data.

Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8AM - 4PM.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=199 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks Daytime mean diastolic blood pressure <90 mmHg	98.5 Percentage of participants
Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks Daytime mean systolic blood pressure <140 mmHg	96.5 Percentage of participants
Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks Daytime mean systolic blood pressure <135 mmHg	93.5 Percentage of participants
Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks Daytime mean systolic blood pressure <130 mmHg	83.9 Percentage of participants
Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks Daytime mean systolic blood pressure <120 mmHg	51.8 Percentage of participants
Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks Daytime mean diastolic blood pressure <85 mmHg	92.5 Percentage of participants
Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks Daytime mean diastolic blood pressure <80 mmHg	83.9 Percentage of participants
Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks Daytime mean blood pressure <140/90 mmHg	95.0 Percentage of participants
Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks Daytime mean blood pressure <135/95 mmHg	88.4 Percentage of participants
Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks Daytime mean blood pressure <135/80 mmHg	81.9 Percentage of participants
Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks Daytime mean blood pressure <130/80 mmHg	77.4 Percentage of participants
Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks Daytime mean blood pressure <125/75 mmHg	56.8 Percentage of participants
Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks Daytime mean blood pressure <120/80 mmHg	51.3 Percentage of participants
Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks Daytime mean blood pressure <120/70 mmHg	33.2 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 12 week ABPM data.

Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Nighttime is defined as 10p.m. - 6 a.m.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=229 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks Nighttime mean systolic blood pressure <140 mmHg	97.8 Percentage of participants
Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks Nighttime mean systolic blood pressure <135 mmHg	94.3 Percentage of participants
Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks Nighttime mean systolic blood pressure <130 mmHg	92.6 Percentage of participants
Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks Nighttime mean systolic blood pressure <120 mmHg	74.7 Percentage of participants
Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks Nighttime mean diastolic blood pressure <90 mmHg	99.6 Percentage of participants
Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks Nighttime mean diastolic blood pressure <85 mmHg	98.3 Percentage of participants
Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks Nighttime mean diastolic blood pressure <80 mmHg	94.8 Percentage of participants
Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks Nighttime mean blood pressure <140/90 mmHg	97.4 Percentage of participants
Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks Nighttime mean blood pressure <135/95 mmHg	93.4 Percentage of participants
Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks Nighttime mean blood pressure <135/80 mmHg	90.8 Percentage of participants
Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks Nighttime mean blood pressure <130/80 mmHg	89.1 Percentage of participants
Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks Nighttime mean blood pressure <125/75 mmHg	77.7 Percentage of participants
Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks Nighttime mean blood pressure <120/80 mmHg	74.2 Percentage of participants
Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks Nighttime mean blood pressure <120/70 mmHg	62.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to 20 weeks

Population: Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 20 week ABPM data.

Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Nighttime is defined as 10 p.m. - 6 a.m.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=199 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks Nighttime mean systolic blood pressure <140 mmHg	99.5 Percentage of participants
Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks Nighttime mean systolic blood pressure <135 mmHg	99.5 Percentage of participants
Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks Nighttime mean systolic blood pressure <130 mmHg	97.5 Percentage of participants
Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks Nighttime mean systolic blood pressure <120 mmHg	86.4 Percentage of participants
Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks Nighttime mean diastolic blood pressure <90 mmHg	99.5 Percentage of participants
Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks Nighttime mean diastolic blood pressure <85 mmHg	98.5 Percentage of participants
Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks Nighttime mean diastolic blood pressure <80 mmHg	96.0 Percentage of participants
Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks Nighttime mean blood pressure <140/90 mmHg	99.0 Percentage of participants
Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks Nighttime mean blood pressure <135/95 mmHg	98.5 Percentage of participants
Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks Nighttime mean blood pressure <135/80 mmHg	96.0 Percentage of participants
Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks Nighttime mean blood pressure <130/80 mmHg	95.0 Percentage of participants
Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks Nighttime mean blood pressure <125/75 mmHg	88.9 Percentage of participants
Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks Nighttime mean blood pressure <120/80 mmHg	85.9 Percentage of participants
Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks Nighttime mean blood pressure <120/70 mmHg	78.9 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 12 week ABPM data.

Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=229 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks 24-hour mean systolic blood pressure <140 mmHg	95.6 Percentage of participants
Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks 24-hour mean systolic blood pressure <135 mmHg	90.4 Percentage of participants
Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks 24-hour mean systolic blood pressure <130 mmHg	79.9 Percentage of participants
Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks 24-hour mean systolic blood pressure <120 mmHg	47.2 Percentage of participants
Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks 24-hour mean diastolic blood pressure <90 mmHg	98.7 Percentage of participants
Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks 24-hour mean diastolic blood pressure <85 mmHg	96.1 Percentage of participants
Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks 24-hour mean diastolic blood pressure <80 mmHg	84.7 Percentage of participants
Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks 24-hour mean blood pressure <140/90 mmHg	94.3 Percentage of participants
Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks 24-hour mean blood pressure <135/95 mmHg	89.1 Percentage of participants
Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks 24-hour mean blood pressure <135/80 mmHg	80.3 Percentage of participants
Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks 24-hour mean blood pressure <130/80 mmHg	73.4 Percentage of participants
Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks 24-hour mean blood pressure <125/75 mmHg	52.4 Percentage of participants
Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks 24-hour mean blood pressure <120/80 mmHg	45.9 Percentage of participants
Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks 24-hour mean blood pressure <120/70 mmHg	27.5 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to 20 weeks

Population: Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 20 week ABPM data.

Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=199 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks 24-hour mean systolic blood pressure <140 mmHg	99.5 Percentage of participants
Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks 24-hour mean systolic blood pressure <135 mmHg	97.5 Percentage of participants
Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks 24-hour mean systolic blood pressure <130 mmHg	94.5 Percentage of participants
Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks 24-hour mean systolic blood pressure <120 mmHg	70.4 Percentage of participants
Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks 24-hour mean diastolic blood pressure <90 mmHg	100.0 Percentage of participants
Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks 24-hour mean diastolic blood pressure <85 mmHg	97.5 Percentage of participants
Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks 24-hour mean diastolic blood pressure <80 mmHg	93.0 Percentage of participants
Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks 24-hour mean blood pressure <140/90 mmHg	99.5 Percentage of participants
Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks 24-hour mean blood pressure <135/95 mmHg	96.0 Percentage of participants
Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks 24-hour mean blood pressure <135/80 mmHg	92.5 Percentage of participants
Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks 24-hour mean blood pressure <130/80 mmHg	90.5 Percentage of participants
Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks 24-hour mean blood pressure <125/75 mmHg	75.4 Percentage of participants
Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks 24-hour mean blood pressure <120/80 mmHg	70.4 Percentage of participants
Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks 24-hour mean blood pressure <120/70 mmHg	55.3 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 12 week ABPM data.

Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8 a.m. to 4 p.m. Nighttime is defined as 10 p.m. to 6 a.m.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=229 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Change From Baseline to Week 12 in Ambulatory Systolic and Diastolic Blood Pressure Values 24-hour mean systolic blood pressure	-14.8 mm Hg Standard Error 0.72
Change From Baseline to Week 12 in Ambulatory Systolic and Diastolic Blood Pressure Values Mean daytime systolic blood pressure	-16.3 mm Hg Standard Error 0.77
Change From Baseline to Week 12 in Ambulatory Systolic and Diastolic Blood Pressure Values Mean nighttime systolic blood pressure	-12.5 mm Hg Standard Error 0.84
Change From Baseline to Week 12 in Ambulatory Systolic and Diastolic Blood Pressure Values Systolic blood pressure - last 2 hours of dose	-13.6 mm Hg Standard Error 1.04
Change From Baseline to Week 12 in Ambulatory Systolic and Diastolic Blood Pressure Values Systolic blood pressure - last 4 hours of dose	-13.0 mm Hg Standard Error 0.90
Change From Baseline to Week 12 in Ambulatory Systolic and Diastolic Blood Pressure Values Systolic blood pressure - last 6 hours of dose	-12.6 mm Hg Standard Error 0.85
Change From Baseline to Week 12 in Ambulatory Systolic and Diastolic Blood Pressure Values 24-hour mean diastolic blood pressure	-9.4 mm Hg Standard Error 0.46
Change From Baseline to Week 12 in Ambulatory Systolic and Diastolic Blood Pressure Values Mean daytime diastolic blood pressure	-10.6 mm Hg Standard Error 0.51
Change From Baseline to Week 12 in Ambulatory Systolic and Diastolic Blood Pressure Values Mean nighttime diastolic blood pressure	-7.6 mm Hg Standard Error 0.59
Change From Baseline to Week 12 in Ambulatory Systolic and Diastolic Blood Pressure Values Diastolic blood pressure - last 2 hours of dose	-8.6 mm Hg Standard Error 0.70
Change From Baseline to Week 12 in Ambulatory Systolic and Diastolic Blood Pressure Values Diastolic blood pressure - last 4 hours of dose	-8.0 mm Hg Standard Error 0.60
Change From Baseline to Week 12 in Ambulatory Systolic and Diastolic Blood Pressure Values Diastolic blood pressure - last 6 hours of dose	-7.7 mm Hg Standard Error 0.57

SECONDARY outcome

Timeframe: Baseline to 20 weeks

Population: Ambulatory blood pressure (ABPM) subset of participants who have both technically successful baseline and 20 week ABPM data.

Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8 a.m. to 4 p.m. Nighttime is defined as 10 p.m. to 6 a.m.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=199 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Change From Baseline to Week 20 in Ambulatory Systolic and Diastolic Blood Pressure Values 24-hour mean systolic blood pressure	-21.0 mm Hg Standard Error 0.84
Change From Baseline to Week 20 in Ambulatory Systolic and Diastolic Blood Pressure Values Mean daytime systolic blood pressure	-23.2 mm Hg Standard Error 0.94
Change From Baseline to Week 20 in Ambulatory Systolic and Diastolic Blood Pressure Values Mean nighttime systolic blood pressure	-17.5 mm Hg Standard Error 0.94
Change From Baseline to Week 20 in Ambulatory Systolic and Diastolic Blood Pressure Values Systolic blood pressure - last 2 hours of dose	-19.6 mm Hg Standard Error 1.10
Change From Baseline to Week 20 in Ambulatory Systolic and Diastolic Blood Pressure Values Systolic blood pressure - last 4 hours of dose	-18.2 mm Hg Standard Error 1.00
Change From Baseline to Week 20 in Ambulatory Systolic and Diastolic Blood Pressure Values Systolic blood pressure - last 6 hours of dose	-17.9 mm Hg Standard Error 0.95
Change From Baseline to Week 20 in Ambulatory Systolic and Diastolic Blood Pressure Values 24-hour mean diastolic blood pressure	-13.3 mm Hg Standard Error 0.55
Change From Baseline to Week 20 in Ambulatory Systolic and Diastolic Blood Pressure Values Mean daytime diastolic blood pressure	-15.0 mm Hg Standard Error 0.62
Change From Baseline to Week 20 in Ambulatory Systolic and Diastolic Blood Pressure Values Mean nighttime diastolic blood pressure	-11.1 mm Hg Standard Error 0.69
Change From Baseline to Week 20 in Ambulatory Systolic and Diastolic Blood Pressure Values Diastolic blood pressure - last 2 hours of dose	-12.3 mm Hg Standard Error 0.77
Change From Baseline to Week 20 in Ambulatory Systolic and Diastolic Blood Pressure Values Diastolic blood pressure - last 4 hours of dose	-11.6 mm Hg Standard Error 0.69
Change From Baseline to Week 20 in Ambulatory Systolic and Diastolic Blood Pressure Values Diastolic blood pressure - last 6 hours of dose	-11.3 mm Hg Standard Error 0.66

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Population: The analysis population consists of those African American/Black participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=230 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <140 mm Hg, N=230	51.7 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <135 mm Hg, N=230	34.4 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <130 mm Hg, N=230	19.6 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <120 mm Hg, N=230	5.7 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <140 mm Hg, N=231	62.3 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <135 mm Hg, N=231	44.6 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <130 mm Hg, N=231	33.8 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <120 mm Hg, N=231	13.0 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <140 mm Hg, N=232	76.3 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <135 mm Hg, N=232	59.1 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <130 mm Hg, N=232	47.0 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <120 mm Hg, N=232	19.8 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <140 mm Hg, N=232	84.9 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <135 mm Hg, N=232	71.1 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <130 mm Hg, N=232	61.2 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <120 mm Hg, N=232	34.1 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <140 mm Hg, N=232	91.0 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <135 mm Hg, N=232	80.6 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <130 mm Hg, N=232	71.1 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <120 mm Hg, N=232	44.4 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Population: The analysis population consists of those African American/Black participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=230 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <90 mm Hg, N=230	60.9 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <85 mm Hg, N=230	42.2 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <80 mm Hg, N=230	19.6 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <90 mm Hg, N=231	71.9 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <85 mm Hg, N=231	53.7 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <80 mm Hg, N=231	30.3 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <90 mm Hg, N=232	82.3 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <85 mm Hg, N=232	66.0 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <80 mm Hg, N=232	45.3 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <90 mm Hg, N=232	92.2 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <85 mm Hg, N=232	76.3 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <80 mm Hg, N=232	55.2 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <90 mm Hg, N=232	94.8 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <85 mm Hg, N=232	80.6 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <80 mm Hg, N=232	61.2 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Population: The analysis population consists of those African American/Black participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=230 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <140/90 mm Hg, N=230	45.7 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <135/80 mm Hg, N=230	14.8 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <130/80 mm Hg, N=230	10.4 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <120/80 mm Hg, N=230	3.9 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <140/90 mm Hg, N=231	55.0 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <135/80 mm Hg, N=231	23.8 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <130/80 mm Hg, N=232	20.8 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <120/80 mm Hg, N=232	10.4 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <140/90mm Hg, N=232	68.5 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <135/80 mm Hg, N=232	38.4 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <130/80 mm Hg, N=232	35.8 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <120/80 mm Hg, N=232	16.4 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <140/90 mm Hg, N=232	80.6 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <135/80 mm Hg, N=232	49.1 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <130/80 mm Hg, N=232	47.4 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <120/80 mm Hg, N=232	30.6 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <140/90 mm Hg, N=232	86.6 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <135/80 mm Hg, N=232	57.8 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <130/80 mm Hg, N=232	55.2 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <120/80 mm Hg, N=232	39.7 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Population: The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=230 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: ≤ 15 mm Hg, N=230	60.0 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >15 and ≤ 30 mm Hg, N=230	32.2 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >30 and ≤ 45 mm Hg, N=230	7.4 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >45 mm Hg, N=230	0.4 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >45 mm Hg, N=189	8.5 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: ≤ 15 mm Hg, N=220	53.6 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >15 and ≤ 30 mm Hg, N=220	38.2 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >30 and ≤ 45 mm Hg, N=220	7.3 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >45 mm Hg, N=220	0.9 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: ≤ 15 mm Hg, N=208	38.9 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >15 and ≤ 30 mm Hg, N=208	41.8 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >30 and ≤ 45 mm Hg, N=208	16.4 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >45 mm Hg, N=208	2.9 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: ≤ 15 mm Hg, N=199	30.7 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >15 and ≤ 30 mm Hg, N=199	37.2 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >30 and ≤ 45 mm Hg, N=199	25.1 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >45 mm Hg, N=199	7.0 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: ≤ 15 mm Hg, N=189	24.3 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >15 and ≤ 30 mm Hg, N=189	37.6 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >30 and ≤ 45 mm Hg, N=189	29.6 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Population: The analysis population consists of those participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=230 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: ≤ 10 mm Hg, N=230	70.0 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >10 and ≤ 15 mm Hg, N=230	17.8 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >15 and ≤ 20 mm Hg, N=230	7.9 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >20 mm Hg, N=230	4.4 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: ≤ 10 mm Hg, N=220	66.8 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >10 and ≤ 15 mm Hg, N=220	15.0 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >15 and ≤ 20 mm Hg, N=220	10.9 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >20 mm Hg, N=220	7.3 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: ≤ 10 mm Hg, N=208	54.8 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >10 and ≤15 mm Hg, N=208	21.2 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >15 and ≤ 20 mm Hg, N=208	12.0 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >20 mm Hg, N=208	12.0 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: ≤ 10 mm Hg, N=199	38.7 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >10 and ≤ 15 mm Hg, N=199	19.6 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >15 and ≤ 20 mm Hg, N=199	23.1 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >20 mm Hg, N=199	18.6 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: ≤ 10 mm Hg, N=189	36.0 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >10 and ≤ 15 mm Hg, N=189	19.6 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >15 and ≤ 20 mm Hg, N=189	20.6 Percentage of Participants
Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >20 mm Hg, N=189	23.8 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Population: The analysis population consists of those Asian participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=128 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <140 mm Hg, N=128	64.8 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <135 mm Hg, N=128	51.6 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <130 mm Hg, N=128	35.2 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <120 mm Hg, N=128	11.7 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <140 mm Hg, N=128	76.6 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <135 mm Hg, N=128	67.2 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <130 mm Hg, N=128	51.6 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <120 mm Hg, N=128	25.0 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <140 mm Hg, N=128	89.1 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <135 mm Hg, N=128	78.9 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <130 mm Hg, N=128	66.4 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <120 mm Hg, N=128	38.3 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <140 mm Hg, N=128	95.3 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <135 mm Hg, N=128	89.8 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <130 mm Hg, N=128	81.3 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <120 mm Hg, N=128	47.7 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <140 mm Hg, N=128	97.7 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <135 mm Hg, N=128	93.0 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <130 mm Hg, N=128	85.9 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <120 mm Hg, N=128	51.6 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Population: The analysis population consists of those Asian participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=128 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Asain Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <90 mm Hg, N=128	83.6 Percentage of Participants
Percentage of Asain Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <85 mm Hg, N=128	69.5 Percentage of Participants
Percentage of Asain Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <80 mm Hg, N=128	45.3 Percentage of Participants
Percentage of Asain Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <90 mm Hg, N=128	89.1 Percentage of Participants
Percentage of Asain Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <85 mm Hg, N=128	79.7 Percentage of Participants
Percentage of Asain Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <80 mm Hg, N=128	60.2 Percentage of Participants
Percentage of Asain Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <90 mm Hg, N=128	95.3 Percentage of Participants
Percentage of Asain Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <85 mm Hg, N=128	87.5 Percentage of Participants
Percentage of Asain Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <80 mm Hg, N=128	71.1 Percentage of Participants
Percentage of Asain Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <90 mm Hg, N=128	96.9 Percentage of Participants
Percentage of Asain Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <85 mm Hg, N=128	93.0 Percentage of Participants
Percentage of Asain Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <80 mm Hg, N=128	82.0 Percentage of Participants
Percentage of Asain Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <90 mm Hg, N=128	96.9 Percentage of Participants
Percentage of Asain Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <85 mm Hg, N=128	93.0 Percentage of Participants
Percentage of Asain Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <80 mm Hg, N=128	85.2 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Population: The analysis population consists of those Asian participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=126 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: ≤ 15 mm Hg, N=126	43.7 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >15 and ≤ 30 mm Hg, N=126	38.1 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >30 and ≤ 45 mm Hg, N=126	15.9 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >45 mm Hg, N=126	2.4 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: ≤ 15 mm Hg, N=123	40.7 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >15 and ≤ 30 mm Hg, N=123	35.8 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >30 and ≤ 45 mm Hg, N=123	22.0 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >45 mm Hg, N=123	1.6 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: ≤ 15 mm Hg, N=120	28.3 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >15 and ≤ 30 mm Hg, N=120	39.2 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >30 and ≤ 45 mm Hg, N=120	27.5 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >45 mm Hg, N=120	5.0 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: ≤ 15 mm Hg, N=112	20.5 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >15 and ≤ 30 mm Hg, N=112	36.6 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >30 and ≤ 45 mm Hg, N=112	31.3 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >45 mm Hg, N=112	11.6 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: ≤ 15 mm Hg, N=105	29.5 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >15 and ≤ 30 mm Hg, N=105	28.6 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >30 and ≤ 45 mm Hg, N=105	33.3 Percentage of Participants
Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >45 mm Hg, N=105	8.6 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Population: The analysis population consists of those Asian participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=126 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: ≤ 10 mm Hg, N=126	47.6 Percentage of Participants
Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >10 and ≤ 15 mm Hg, N=126	26.2 Percentage of Participants
Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >15 and ≤ 20 mm Hg, N=126	13.5 Percentage of Participants
Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >20 mm Hg, N=126	12.7 Percentage of Participants
Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: ≤ 10 mm Hg, N=123	38.2 Percentage of Participants
Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >10 and ≤ 15 mm Hg, N=123	24.4 Percentage of Participants
Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >15 and ≤ 20 mm Hg, N=123	22.0 Percentage of Participants
Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >20 mm Hg, N=123	15.5 Percentage of Participants
Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: ≤ 10 mm Hg, N=120	33.3 Percentage of Participants
Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >10 and ≤15 mm Hg, N=120	25.8 Percentage of Participants
Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >15 and ≤ 20 mm Hg, N=120	19.2 Percentage of Participants
Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >20 mm Hg, N=120	21.7 Percentage of Participants
Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: ≤ 10 mm Hg, N=112	27.7 Percentage of Participants
Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >10 and ≤ 15 mm Hg, N=112	17.0 Percentage of Participants
Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >15 and ≤ 20 mm Hg, N=112	20.5 Percentage of Participants
Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >20 mm Hg, N=112	34.8 Percentage of Participants
Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: ≤ 10 mm Hg, N=105	36.2 Percentage of Participants
Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >10 and ≤ 15 mm Hg, N=105	16.2 Percentage of Participants
Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >15 and ≤ 20 mm Hg, N=105	18.1 Percentage of Participants
Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >20 mm Hg, N=105	29.5 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Population: The analysis population consists of those Hispanic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=98 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <135 mm Hg, N=100	83.0 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <130 mm Hg, N=100	72.0 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <120 mm Hg, N=100	41.0 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <140 mm Hg, N=98	55.1 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <135 mm Hg, N=98	39.8 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <130 mm Hg, N=98	31.6 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <120 mm Hg, N=98	10.2 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <140 mm Hg, N=100	64.0 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <135 mm Hg, N=100	51.0 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <130 mm Hg, N=100	41.0 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <120 mm Hg, N=100	15.0 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <140 mm Hg, N=100	77.0 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <135 mm Hg, N=100	67.0 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <130 mm Hg, N=100	54.0 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <120 mm Hg, N=100	30.0 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <140 mm Hg, N=100	84.0 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <135 mm Hg, N=100	77.0 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <130 mm Hg, N=100	66.0 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <120 mm Hg, N=100	37.0 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <140 mm Hg, N=100	88.0 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Population: The analysis population consists of those Hispanic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=98 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <90 mm Hg, N=98	66.3 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <85 mm Hg, N=98	53.1 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <80 mm Hg, N=98	34.7 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <90 mm Hg, N=100	85.0 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <85 mm Hg, N=100	70.0 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <80 mm Hg, N=100	48.0 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <90 mm Hg, N=100	92.0 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <85 mm Hg, N=100	78.0 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <80 mm Hg, N=100	62.0 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <90 mm Hg, N=100	96.0 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <85 mm Hg, N=100	90.0 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <80 mm Hg, N=100	75.0 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <90 mm Hg, N=100	96.0 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <85 mm Hg, N=100	90.0 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <80 mm Hg, N=100	75.0 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Population: The analysis population consists of those Hispanic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=98 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: ≤ 15 mm Hg, N=98	50.0 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >15 and ≤ 30 mm Hg, N=98	37.8 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >30 and ≤ 45 mm Hg, N=98	7.1 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >45 mm Hg, N=98	5.1 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: ≤ 15 mm Hg, N=91	42.9 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >15 and ≤ 30 mm Hg, N=91	44.0 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >30 and ≤ 45 mm Hg, N=91	9.9 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >45 mm Hg, N=91	3.3 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: ≤ 15 mm Hg, N=83	31.3 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >15 and ≤ 30 mm Hg, N=83	36.1 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >30 and ≤ 45 mm Hg, N=83	25.3 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >45 mm Hg, N=83	7.2 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: ≤ 15 mm Hg, N=75	22.7 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >15 and ≤ 30 mm Hg, N=75	36.0 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >30 and ≤ 45 mm Hg, N=75	34.7 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >45 mm Hg, N=75	6.7 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: ≤ 15 mm Hg, N=71	23.9 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >15 and ≤ 30 mm Hg, N=71	33.8 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >30 and ≤ 45 mm Hg, N=71	33.8 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >45 mm Hg, N=71	8.5 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Population: The analysis population consists of those Hispanic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=98 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: ≤ 10 mm Hg, N=98	65.3 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >10 and ≤ 15 mm Hg, N=98	16.3 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >15 and ≤ 20 mm Hg, N=98	8.2 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >20 mm Hg, N=98	10.2 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: ≤ 10 mm Hg, N=91	52.8 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >10 and ≤ 15 mm Hg, N=91	18.7 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >15 and ≤ 20 mm Hg, N=91	14.3 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >20 mm Hg, N=91	14.3 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: ≤ 10 mm Hg, N=83	41.0 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >10 and ≤15 mm Hg, N=83	20.5 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >15 and ≤ 20 mm Hg, N=83	14.5 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >20 mm Hg, N=83	24.1 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: ≤ 10 mm Hg, N=75	30.7 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >10 and ≤ 15 mm Hg, N=75	25.3 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >15 and ≤ 20 mm Hg, N=75	16.0 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >20 mm Hg, N=75	28.0 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: ≤ 10 mm Hg, N=71	31.0 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >10 and ≤ 15 mm Hg, N=71	12.7 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >15 and ≤ 20 mm Hg, N=71	26.8 Percentage of Participants
Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >20 mm Hg, N=71	29.6 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Population: The analysis population consists of those elderly participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts. Elderly is defined as greater than or = to 65 years of age.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=227 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <140 mm Hg, N=227	52.0 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <135 mm Hg, N=227	37.9 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <130 mm Hg, N=227	23.4 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <120 mm Hg, N=227	9.7 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <140 mm Hg, N=227	67.0 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <135 mm Hg, N=227	57.7 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <130 mm Hg, N=227	43.6 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <120 mm Hg, N=227	18.1 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <140 mm Hg, N=227	80.6 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <135 mm Hg, N=227	70.0 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <130 mm Hg, N=227	56.8 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <120 mm Hg, N=227	28.6 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <140 mm Hg, N=227	87.7 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <135 mm Hg, N=227	79.7 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <130 mm Hg, N=227	70.9 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <120 mm Hg, N=227	43.6 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <140 mm Hg, N=227	91.6 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <135 mm Hg, N=227	85.9 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <130 mm Hg, N=227	78.9 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <120 mm Hg, N=227	50.7 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Population: The analysis population consists of those elderly participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts. Elderly is defined as greater than or = to 65 years of age.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=227 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <90 mm Hg, N=227	97.4 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <85 mm Hg, N=227	92.1 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <80 mm Hg, N=227	80.2 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <90 mm Hg, N=227	88.1 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <85 mm Hg, N=227	76.7 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <80 mm Hg, N=227	58.2 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <90 mm Hg, N=227	92.1 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <85 mm Hg, N=227	83.7 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <80 mm Hg, N=227	71.8 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <90 mm Hg, N=227	98.7 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <85 mm Hg, N=227	94.3 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <80 mm Hg, N=227	88.6 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <90 mm Hg, N=227	98.7 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <85 mm Hg, N=227	95.2 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <80 mm Hg, N=227	90.3 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Population: The analysis population consists of those elderly participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts. Elderly is defined as greater than or = to 65 years of age.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=224 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: ≤ 15 mm Hg, N=224	47.3 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >15 and ≤ 30 mm Hg, N=224	40.2 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >30 and ≤ 45 mm Hg, N=224	11.2 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >45 mm Hg, N=224	1.3 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: ≤ 15 mm Hg, N=217	42.9 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >15 and ≤ 30 mm Hg, N=217	37.8 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >30 and ≤ 45 mm Hg, N=217	16.6 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >45 mm Hg, N=217	2.8 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: ≤ 15 mm Hg, N=199	26.6 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >15 and ≤ 30 mm Hg, N=199	46.7 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >30 and ≤ 45 mm Hg, N=199	24.6 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >45 mm Hg, N=199	2.0 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: ≤ 15 mm Hg, N=179	17.9 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >15 and ≤ 30 mm Hg, N=179	32.4 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >30 and ≤ 45 mm Hg, N=179	39.7 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >45 mm Hg, N=179	10.1 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: ≤ 15 mm Hg, N=166	14.5 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >15 and ≤ 30 mm Hg, N=166	37.4 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >30 and ≤ 45 mm Hg, N=166	38.0 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >45 mm Hg, N=166	10.2 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Population: The analysis population consists of those elderly participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts. Elderly is defined as greater than or = to 65 years of age.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=224 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >20 mm Hg, N=166	20.5 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: ≤ 10 mm Hg, N=224	63.8 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >10 and ≤ 15 mm Hg, N=224	20.5 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >15 and ≤ 20 mm Hg, N=224	9.4 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >20 mm Hg, N=224	6.3 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: ≤ 10 mm Hg, N=217	57.1 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >10 and ≤ 15 mm Hg, N=217	19.8 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >15 and ≤ 20 mm Hg, N=217	14.3 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >20 mm Hg, N=217	8.8 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: ≤ 10 mm Hg, N=199	45.2 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >10 and ≤15 mm Hg, N=199	25.1 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >15 and ≤ 20 mm Hg, N=199	15.6 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >20 mm Hg, N=199	14.1 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: ≤ 10 mm Hg, N=179	27.4 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >10 and ≤ 15 mm Hg, N=179	25.1 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >15 and ≤ 20 mm Hg, N=179	22.9 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >20 mm Hg, N=179	24.6 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: ≤ 10 mm Hg, N=166	34.9 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >10 and ≤ 15 mm Hg, N=166	20.5 Percentage of Participants
Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >15 and ≤ 20 mm Hg, N=166	24.1 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Population: The analysis population consists of those type 2 diabetic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=190 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <140 mm Hg, N=190	54.7 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <135 mm Hg, N=190	41.1 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <130 mm Hg, N=190	26.3 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <120 mm Hg, N=190	10.0 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <140 mm Hg, N=190	69.0 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <135 mm Hg, N=190	56.3 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <130 mm Hg, N=190	42.6 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <120 mm Hg, N=190	15.8 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <140 mm Hg, N=190	81.6 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <135 mm Hg, N=190	69.5 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <130 mm Hg, N=190	57.9 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <120 mm Hg, N=190	30.0 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <140 mm Hg, N=190	87.9 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <135 mm Hg, N=190	79.0 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <130 mm Hg, N=190	69.0 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <120 mm Hg, N=190	39.5 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <140 mm Hg, N=190	91.1 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <135 mm Hg, N=190	84.2 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <130 mm Hg, N=190	75.3 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <120 mm Hg, N=190	48.4 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Population: The analysis population consists of those type 2 diabetic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=190 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <90 mm Hg, N=190	75.8 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <85 mm Hg, N=190	64.2 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <80 mm Hg, N=190	39.0 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <90 mm Hg, N=190	85.8 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <85 mm Hg, N=190	72.6 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <80 mm Hg, N=190	51.1 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <90 mm Hg, N=190	94.2 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <85 mm Hg, N=190	83.2 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <80 mm Hg, N=190	63.7 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <90 mm Hg, N=190	97.9 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <85 mm Hg, N=190	89.0 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <80 mm Hg, N=190	70.5 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <90 mm Hg, N=190	99.0 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <85 mm Hg, N=190	90.5 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <80 mm Hg, N=190	76.8 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Population: The analysis population consists of those type 2 diabetic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=189 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: ≤ 15 mm Hg, N=189	56.1 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >15 and ≤ 30 mm Hg, N=189	36.0 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >30 and ≤ 45 mm Hg, N=189	7.9 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >45 mm Hg, N=189	0.0 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: ≤ 15 mm Hg, N=181	54.1 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >15 and ≤ 30 mm Hg, N=181	34.3 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >30 and ≤ 45 mm Hg, N=181	11.6 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >45 mm Hg, N=181	0.0 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: ≤ 15 mm Hg, N=170	35.3 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >15 and ≤ 30 mm Hg, N=170	38.2 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >30 and ≤ 45 mm Hg, N=170	22.9 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >45 mm Hg, N=170	3.5 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: ≤ 15 mm Hg, N=156	28.2 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >15 and ≤ 30 mm Hg, N=156	40.4 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >30 and ≤ 45 mm Hg, N=156	26.3 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >45 mm Hg, N=156	5.1 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: ≤ 15 mm Hg, N=150	26.0 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >15 and ≤ 30 mm Hg, N=150	40.0 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >30 and ≤ 45 mm Hg, N=150	26.7 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >45 mm Hg, N=150	7.3 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Population: The analysis population consists of those type 2 diabetic participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=189 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >15 and ≤ 20 mm Hg, N=170	12.9 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >20 mm Hg, N=170	13.5 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: ≤ 10 mm Hg, N=189	67.7 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >10 and ≤ 15 mm Hg, N=189	16.9 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >15 and ≤ 20 mm Hg, N=189	11.6 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >20 mm Hg, N=189	3.7 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: ≤ 10 mm Hg, N=181	60.8 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >10 and ≤ 15 mm Hg, N=181	20.4 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >15 and ≤ 20 mm Hg, N=181	14.9 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >20 mm Hg, N=181	3.9 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: ≤ 10 mm Hg, N=170	41.2 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >10 and ≤15 mm Hg, N=170	32.4 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: ≤ 10 mm Hg, N=156	32.7 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >10 and ≤ 15 mm Hg, N=156	26.9 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >15 and ≤ 20 mm Hg, N=156	21.8 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >20 mm Hg, N=156	18.6 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: ≤ 10 mm Hg, N=150	37.3 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >10 and ≤ 15 mm Hg, N=150	18.0 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >15 and ≤ 20 mm Hg, N=150	26.0 Percentage of Participants
Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >20 mm Hg, N=150	18.7 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Population: The analysis population consists of those obese participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts. Obesity is defined as Body Mass Index ≥30 kg/m2

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=497 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <140 mm Hg, N=497	51.3 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <135 mm Hg, N=497	37.2 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <130 mm Hg, N=497	23.3 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <120 mm Hg, N=497	7.9 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <140 mm Hg, N=500	63.2 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <135 mm Hg, N=500	49.2 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <130 mm Hg, N=500	37.0 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <120 mm Hg, N=500	13.8 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <140 mm Hg, N=500	76.6 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <135 mm Hg, N=500	61.6 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <130 mm Hg, N=500	49.2 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <120 mm Hg, N=500	23.2 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <140 mm Hg, N=500	85.8 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <135 mm Hg, N=500	75.6 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <130 mm Hg, N=500	63.6 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <120 mm Hg, N=500	34.6 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <140 mm Hg, N=500	90.2 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <135 mm Hg, N=500	82.6 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <130 mm Hg, N=500	72.2 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <120 mm Hg, N=500	43.0 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Population: The analysis population consists of those obese participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts. Obesity is defined as Body Mass Index ≥30 kg/m2

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=497 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <90 mm Hg, N=497	63.2 Percentage of Participants
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <85 mm Hg, N=497	46.3 Percentage of Participants
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <80 mm Hg, N=497	26.0 Percentage of Participants
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <90 mm Hg, N=497	77.2 Percentage of Participants
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <85 mm Hg, N=500	59.4 Percentage of Participants
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <80 mm Hg, N=500	38.8 Percentage of Participants
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <90 mm Hg, N=500	86.6 Percentage of Participants
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <85 mm Hg, N=500	69.8 Percentage of Participants
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <80 mm Hg, N=500	48.4 Percentage of Participants
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <90 mm Hg, N=500	93.2 Percentage of Participants
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <85 mm Hg, N=500	80.4 Percentage of Participants
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <80 mm Hg, N=500	60.4 Percentage of Participants
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <90 mm Hg, N=500	94.6 Percentage of Participants
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <85 mm Hg, N=500	83.8 Percentage of Participants
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <80 mm Hg, N=500	67.6 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Population: The analysis population consists of those obese participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included may vary because of missing data and the number of dropouts. Obesity is defined as Body Mass Index ≥30 kg/m2.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=495 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: ≤ 15 mm Hg, N=495	56.0 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >15 and ≤ 30 mm Hg, N=495	35.2 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >30 and ≤ 45 mm Hg, N=495	8.5 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >45 mm Hg, N=495	0.4 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: ≤ 15 mm Hg, N=468	52.4 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >15 and ≤ 30 mm Hg, N=468	35.9 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >30 and ≤ 45 mm Hg, N=468	10.3 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >45 mm Hg, N=468	1.5 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: ≤ 15 mm Hg, N=436	37.8 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >15 and ≤ 30 mm Hg, N=436	42.4 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >30 and ≤ 45 mm Hg, N=436	17.4 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >45 mm Hg, N=436	2.5 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: ≤ 15 mm Hg, N=400	27.8 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >15 and ≤ 30 mm Hg, N=400	36.0 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >30 and ≤ 45 mm Hg, N=400	27.5 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >45 mm Hg, N=400	8.8 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: ≤ 15 mm Hg, N=379	20.6 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >15 and ≤ 30 mm Hg, N=379	37.5 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >30 and ≤ 45 mm Hg, N=379	33.3 Percentage of Participants
Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >45 mm Hg, N=379	8.7 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Population: The analysis population consists of those obese participants who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. However, the number of participants included will vary because of missing data and the number of dropouts. Obesity is defined as Body Mass Index ≥30 kg/m2

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=495 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: ≤ 10 mm Hg, N=495	67.5 Percentage of Participants
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >10 and ≤ 15 mm Hg, N=495	17.8 Percentage of Participants
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >15 and ≤ 20 mm Hg, N=495	8.5 Percentage of Participants
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >20 mm Hg, N=495	6.3 Percentage of Participants
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: ≤ 10 mm Hg, N=468	59.4 Percentage of Participants
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >10 and ≤ 15 mm Hg, N=468	19.9 Percentage of Participants
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >15 and ≤ 20 mm Hg, N=468	13.0 Percentage of Participants
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >20 mm Hg, N=468	7.7 Percentage of Participants
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: ≤ 10 mm Hg, N=436	48.9 Percentage of Participants
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >10 and ≤15 mm Hg, N=436	22.5 Percentage of Participants
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >15 and ≤ 20 mm Hg, N=436	16.1 Percentage of Participants
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >20 mm Hg, N=436	12.6 Percentage of Participants
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: ≤ 10 mm Hg, N=400	33.3 Percentage of Participants
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >10 and ≤ 15 mm Hg, N=400	23.0 Percentage of Participants
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >15 and ≤ 20 mm Hg, N=400	19.0 Percentage of Participants
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >20 mm Hg, N=400	24.8 Percentage of Participants
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: ≤ 10 mm Hg, N=379	31.9 Percentage of Participants
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >10 and ≤ 15 mm Hg, N=379	18.7 Percentage of Participants
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >15 and ≤ 20 mm Hg, N=379	22.4 Percentage of Participants
Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >20 mm Hg, N=379	26.9 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Population: Subjects with metabolic syndrome (MS) who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. The number may vary due to missing data and the number of dropouts. MS is defined using waist size,and triglyceride, cholesterol, blood pressure, and body mass index values.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=454 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <140 mm Hg, N=454	56.4 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <135 mm Hg, N=454	41.4 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <130 mm Hg, N=454	27.1 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <120 mm Hg, N=454	7.9 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <140 mm Hg, N=457	67.6 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <135 mm Hg, N=457	54.3 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <130 mm Hg, N=457	40.9 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <120 mm Hg, N=457	16.2 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <140 mm Hg, N=457	81.4 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <135 mm Hg, N=457	67.2 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <130 mm Hg, N=457	54.1 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <120 mm Hg, N=457	27.6 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <140 mm Hg, N=457	88.8 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <135 mm Hg, N=457	80.3 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <130 mm Hg, N=457	67.0 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <120 mm Hg, N=457	39.0 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <140 mm Hg, N=457	91.5 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <135 mm Hg, N=457	85.6 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <130 mm Hg, N=457	74.8 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <120 mm Hg, N=457	47.1 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Population: Subjects with metabolic syndrome (MS) who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. The number may vary due to missing data and the number of dropouts. MS is defined using waist size,and triglyceride, cholesterol, blood pressure, and body mass index values.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=454 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <90 mm Hg, N=454	69.6 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <85 mm Hg, N=454	53.5 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: <80 mm Hg, N=454	31.9 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <90 mm Hg, N=457	82.1 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <85 mm Hg, N=457	66.1 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: <80 mm Hg, N=457	43.5 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <90 mm Hg, N=457	90.4 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <85 mm Hg, N=457	76.6 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: <80 mm Hg, N=457	56.5 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <90 mm Hg, N=457	94.8 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <85 mm Hg, N=457	83.2 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: <80 mm Hg, N=457	65.9 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <90 mm Hg, N=457	95.4 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <85 mm Hg, N=457	86.2 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: <80 mm Hg, N=457	72.0 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Population: Subjects with metabolic syndrome (MS) who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. The number may vary due to missing data and the number of dropouts. MS is defined using waist size,and triglyceride, cholesterol, blood pressure, and body mass index values.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=453 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: ≤ 15 mm Hg, N=453	49.5 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >15 and ≤ 30 mm Hg, N=453	38.4 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >30 and ≤ 45 mm Hg, N=453	11.5 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >45 mm Hg, N=453	0.7 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: ≤ 15 mm Hg, N=431	48.0 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >15 and ≤ 30 mm Hg, N=431	35.5 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >30 and ≤ 45 mm Hg, N=431	14.4 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >45 mm Hg, N=431	2.1 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: ≤ 15 mm Hg, N=402	30.4 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >15 and ≤ 30 mm Hg, N=402	43.8 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >30 and ≤ 45 mm Hg, N=402	22.6 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >45 mm Hg, N=402	3.2 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: ≤ 15 mm Hg, N=371	24.0 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >15 and ≤ 30 mm Hg, N=371	37.7 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >30 and ≤ 45 mm Hg, N=371	29.1 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >45 mm Hg, N=371	9.2 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: ≤ 15 mm Hg, N=356	19.7 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >15 and ≤ 30 mm Hg, N=356	36.5 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >30 and ≤ 45 mm Hg, N=356	36.0 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >45 mm Hg, N=356	7.9 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, 16, 20 weeks

Population: Subjects with metabolic syndrome (MS) who have a baseline and at least 1 post-baseline measurement and who received at least one dose of study medication. The number may vary due to missing data and the number of dropouts. MS is defined using waist size,and triglyceride, cholesterol, blood pressure, and body mass index values.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=453 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: ≤ 10 mm Hg, N=453	62.7 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >10 and ≤ 15 mm Hg, N=453	22.3 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >15 and ≤ 20 mm Hg, N=453	8.6 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 4 weeks: >20 mm Hg, N=453	6.4 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: ≤ 10 mm Hg, N=431	56.6 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >10 and ≤ 15 mm Hg, N=431	19.7 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >15 and ≤ 20 mm Hg, N=431	15.3 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 8 weeks: >20 mm Hg, N=431	8.4 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: ≤ 10 mm Hg, N=402	44.3 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >10 and ≤15 mm Hg, N=402	22.1 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >15 and ≤ 20 mm Hg, N=402	17.4 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 12 weeks: >20 mm Hg, N=402	16.2 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: ≤ 10 mm Hg, N=371	32.4 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >10 and ≤ 15 mm Hg, N=371	24.0 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >15 and ≤ 20 mm Hg, N=371	21.0 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 16 weeks: >20 mm Hg, N=371	22.6 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: ≤ 10 mm Hg, N=356	33.2 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >10 and ≤ 15 mm Hg, N=356	19.4 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >15 and ≤ 20 mm Hg, N=356	22.5 Percentage of Participants
Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks 20 weeks: >20 mm Hg, N=356	25.0 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: Participants previously on a Dihydropyridine Calcium Channel Blocker who have received at least one dose of study medication and who have a baseline value.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=117 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Systolic blood pressure <140 mmHg	73.5 Percentage of participants
Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Systolic blood pressure <135 mmHg	59.0 Percentage of participants
Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Systolic blood pressure <130 mmHg	47.9 Percentage of participants
Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Systolic blood pressure <120 mmHg	18.8 Percentage of participants
Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Diastolic blood pressure <90 mmHg	86.3 Percentage of participants
Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Diastolic blood pressure <85 mmHg	72.7 Percentage of participants
Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Diastolic blood pressure <80 mmHg	48.7 Percentage of participants
Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Blood pressure <140/90 mmHg	68.4 Percentage of participants
Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Blood pressure <135/80 mmHg	40.2 Percentage of participants
Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Blood pressure <130/80 mmHg	34.2 Percentage of participants
Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Blood pressure <120/80 mmHg	16.2 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to 20 weeks

Population: Participants previously on a Dihydropyridine Calcium Channel Blocker who have received at least one dose of study medication and who have a baseline value.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=117 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Systolic blood pressure <140 mmHg	89.7 Percentage of participants
Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Systolic blood pressure <135 mmHg	83.8 Percentage of participants
Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Systolic blood pressure <130 mmHg	69.2 Percentage of participants
Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Systolic blood pressure <120 mmHg	41.0 Percentage of participants
Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Diastolic blood pressure <90 mmHg	91.5 Percentage of participants
Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Diastolic blood pressure <85 mmHg	85.5 Percentage of participants
Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Diastolic blood pressure <80 mmHg	69.2 Percentage of participants
Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Blood pressure <140/90 mmHg	85.5 Percentage of participants
Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Blood pressure <135/80 mmHg	64.1 Percentage of participants
Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Blood pressure <130/80 mmHg	59.8 Percentage of participants
Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Blood pressure <120/80 mmHg	36.8 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: Participants previously on a diuretic who have received at least one dose of study medication and who have a baseline value.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=166 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 12 Weeks Systolic blood pressure <140 mmHg	92.8 Percentage of participants
Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 12 Weeks Systolic blood pressure <135 mmHg	82.5 Percentage of participants
Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 12 Weeks Systolic blood pressure <130 mmHg	78.3 Percentage of participants
Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 12 Weeks Systolic blood pressure <120 mmHg	51.2 Percentage of participants
Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 12 Weeks Diastolic blood pressure <90 mmHg	94.6 Percentage of participants
Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 12 Weeks Diastolic blood pressure <85 mmHg	86.8 Percentage of participants
Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 12 Weeks Diastolic blood pressure <80 mmHg	71.7 Percentage of participants
Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 12 Weeks Blood pressure <140/90 mmHg	88.6 Percentage of participants
Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 12 Weeks Blood pressure <135/80 mmHg	67.5 Percentage of participants
Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 12 Weeks Blood pressure <130/80 mmHg	65.1 Percentage of participants
Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 12 Weeks Blood pressure <120/80 mmHg	48.2 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to 20 weeks

Population: Participants previously on a diuretic who have received at least one dose of study medication and who have a baseline value.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=166 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 20 Weeks Systolic blood pressure <140 mmHg	92.8 Percentage of participants
Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 20 Weeks Systolic blood pressure <135 mmHg	82.5 Percentage of participants
Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 20 Weeks Systolic blood pressure <130 mmHg	78.3 Percentage of participants
Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 20 Weeks Systolic blood pressure <120 mmHg	51.2 Percentage of participants
Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 20 Weeks Diastolic blood pressure <90 mmHg	94.6 Percentage of participants
Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 20 Weeks Diastolic blood pressure <85 mmHg	86.8 Percentage of participants
Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 20 Weeks Diastolic blood pressure <80 mmHg	71.7 Percentage of participants
Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 20 Weeks Blood pressure <140/90 mmHg	88.6 Percentage of participants
Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 20 Weeks Blood pressure <135/80 mmHg	67.5 Percentage of participants
Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 20 Weeks Blood pressure <130/80 mmHg	65.1 Percentage of participants
Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 20 Weeks Blood pressure <120/80 mmHg	48.2 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: Participants previously on an angiotensin converting enzyme inhibitor who have received at least one dose of study medication and who have a baseline value.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=283 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 12 Weeks Systolic blood pressure <140 mmHg	81.3 Percentage of participants
Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 12 Weeks Systolic blood pressure <135 mmHg	69.3 Percentage of participants
Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 12 Weeks Systolic blood pressure <130 mmHg	53.0 Percentage of participants
Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 12 Weeks Systolic blood pressure <120 mmHg	31.5 Percentage of participants
Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 12 Weeks Diastolic blood pressure <90 mmHg	94.4 Percentage of participants
Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 12 Weeks Diastolic blood pressure <85 mmHg	80.6 Percentage of participants
Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 12 Weeks Diastolic blood pressure <80 mmHg	64.3 Percentage of participants
Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 12 Weeks Blood pressure <140/90 mmHg	78.5 Percentage of participants
Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 12 Weeks Blood pressure <135/80 mmHg	52.7 Percentage of participants
Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 12 Weeks Blood pressure <130/80 mmHg	43.5 Percentage of participants
Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 12 Weeks Blood pressure <120/80 mmHg	27.9 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to 20 weeks

Population: Participants previously on an angiotensin converting enzyme inhibitor who have received at least one dose of study medication and who have a baseline value.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=283 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 20 Weeks Systolic blood pressure <140 mmHg	91.5 Percentage of participants
Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 20 Weeks Systolic blood pressure <135 mmHg	84.5 Percentage of participants
Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 20 Weeks Systolic blood pressure <130 mmHg	71.4 Percentage of participants
Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 20 Weeks Systolic blood pressure <120 mmHg	47.4 Percentage of participants
Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 20 Weeks Diastolic blood pressure <90 mmHg	98.2 Percentage of participants
Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 20 Weeks Diastolic blood pressure <85 mmHg	89.8 Percentage of participants
Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 20 Weeks Diastolic blood pressure <80 mmHg	78.5 Percentage of participants
Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 20 Weeks Blood pressure <140/90 mmHg	90.5 Percentage of participants
Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 20 Weeks Blood pressure <135/80 mmHg	71.0 Percentage of participants
Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 20 Weeks Blood pressure <130/80 mmHg	61.5 Percentage of participants
Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 20 Weeks Blood pressure <120/80 mmHg	44.5 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: Participants previously on an angiotensin II receptor blocker who have received at least one dose of study medication and who have a baseline value.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=234 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Systolic blood pressure <140 mmHg	80.8 Percentage of participants
Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Systolic blood pressure <135 mmHg	69.2 Percentage of participants
Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Systolic blood pressure <130 mmHg	56.0 Percentage of participants
Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Systolic blood pressure <120 mmHg	26.1 Percentage of participants
Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Diastolic blood pressure <90 mmHg	89.7 Percentage of participants
Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Diastolic blood pressure <85 mmHg	76.9 Percentage of participants
Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Diastolic blood pressure <80 mmHg	59.0 Percentage of participants
Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Blood pressure <140/90 mmHg	76.1 Percentage of participants
Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Blood pressure <135/80 mmHg	52.6 Percentage of participants
Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Blood pressure <130/80 mmHg	46.2 Percentage of participants
Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Blood pressure <120/80 mmHg	23.1 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to 20 weeks

Population: Participants previously on an angiotensin II receptor blocker who have received at least one dose of study medication and who have a baseline value.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=234 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Systolic blood pressure <140 mmHg	92.3 Percentage of participants
Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Systolic blood pressure <135 mmHg	87.2 Percentage of participants
Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Systolic blood pressure <130 mmHg	79.5 Percentage of participants
Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Systolic blood pressure <120 mmHg	47.4 Percentage of participants
Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Diastolic blood pressure <90 mmHg	96.6 Percentage of participants
Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Diastolic blood pressure <85 mmHg	89.3 Percentage of participants
Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Diastolic blood pressure <80 mmHg	74.8 Percentage of participants
Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Blood pressure <140/90 mmHg	90.6 Percentage of participants
Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Blood pressure <135/80 mmHg	70.1 Percentage of participants
Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Blood pressure <130/80 mmHg	65.0 Percentage of participants
Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Blood pressure <120/80 mmHg	44.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: Participants previously on an beta blocker who have received at least one dose of study medication and who have a baseline value.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=113 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Systolic blood pressure <140 mmHg	88.5 Percentage of participants
Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Systolic blood pressure <135 mmHg	75.2 Percentage of participants
Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Systolic blood pressure <130 mmHg	62.0 Percentage of participants
Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Systolic blood pressure <120 mmHg	33.6 Percentage of participants
Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Diastolic blood pressure <90 mmHg	94.7 Percentage of participants
Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Diastolic blood pressure <85 mmHg	83.2 Percentage of participants
Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Diastolic blood pressure <80 mmHg	61.1 Percentage of participants
Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Blood pressure <140/90 mmHg	86.7 Percentage of participants
Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Blood pressure <135/80 mmHg	55.8 Percentage of participants
Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Blood pressure <130/80 mmHg	49.6 Percentage of participants
Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Blood pressure <120/80 mmHg	29.2 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to 20 weeks

Population: Participants previously on an beta blocker who have received at least one dose of study medication and who have a baseline value.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=113 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Blood pressure <130/80 mmHg	69.9 Percentage of participants
Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Systolic blood pressure <140 mmHg	93.8 Percentage of participants
Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Systolic blood pressure <135 mmHg	87.6 Percentage of participants
Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Systolic blood pressure <130 mmHg	79.7 Percentage of participants
Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Systolic blood pressure <120 mmHg	47.8 Percentage of participants
Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Diastolic blood pressure <90 mmHg	98.2 Percentage of participants
Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Diastolic blood pressure <85 mmHg	89.4 Percentage of participants
Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Diastolic blood pressure <80 mmHg	77.0 Percentage of participants
Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Blood pressure <140/90 mmHg	92.9 Percentage of participants
Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Blood pressure <135/80 mmHg	74.3 Percentage of participants
Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Blood pressure <120/80 mmHg	43.4 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: Participants previously on a Nondihydropyridine Calcium Channel Blocker who have received at least one dose of study medication and who have a baseline value.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=20 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Systolic blood pressure <140 mmHg	100.0 Percentage of participants
Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Systolic blood pressure <135 mmHg	90.0 Percentage of participants
Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Systolic blood pressure <130 mmHg	75.0 Percentage of participants
Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Systolic blood pressure <120 mmHg	25.0 Percentage of participants
Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Diastolic blood pressure <90 mmHg	100.0 Percentage of participants
Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Diastolic blood pressure <85 mmHg	95.0 Percentage of participants
Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Diastolic blood pressure <80 mmHg	75.0 Percentage of participants
Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Blood pressure <140/90 mmHg	100.0 Percentage of participants
Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Blood pressure <135/80 mmHg	70.0 Percentage of participants
Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Blood pressure <130/80 mmHg	65.0 Percentage of participants
Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks Blood pressure <120/80 mmHg	20.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to 20 weeks

Population: Participants previously on a Nondihydropyridine Calcium Channel Blocker who have received at least one dose of study medication and who have a baseline value.

Outcome measures

Outcome measures
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=20 Participants Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Systolic blood pressure <140 mmHg	100.0 Percentage of participants
Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Systolic blood pressure <135 mmHg	100.0 Percentage of participants
Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Systolic blood pressure <130 mmHg	95.0 Percentage of participants
Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Systolic blood pressure <120 mmHg	45.0 Percentage of participants
Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Diastolic blood pressure <90 mmHg	100.0 Percentage of participants
Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Diastolic blood pressure <85 mmHg	95.0 Percentage of participants
Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Diastolic blood pressure <80 mmHg	95.0 Percentage of participants
Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Blood pressure <140/90 mmHg	100.0 Percentage of participants
Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Blood pressure <135/80 mmHg	95.0 Percentage of participants
Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Blood pressure <130/80 mmHg	95.0 Percentage of participants
Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks Blood pressure <120/80 mmHg	40.0 Percentage of participants

Adverse Events

Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide

Serious events: 13 serious events

Other events: 241 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=999 participants at risk Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
Cardiac disorders myocardial infarction	0.20% 2/999 • Number of events 2 • Adverse events were collected for the 20-week treatment period + a 2-week post-treatment follow-up, plus an additional 30 days after last dose. AE's were either observed by the investigator via physical examinations and laboratory testing and/or reported by the subject.
Psychiatric disorders depession	0.10% 1/999 • Number of events 1 • Adverse events were collected for the 20-week treatment period + a 2-week post-treatment follow-up, plus an additional 30 days after last dose. AE's were either observed by the investigator via physical examinations and laboratory testing and/or reported by the subject.
Gastrointestinal disorders oesophageal rupture	0.10% 1/999 • Number of events 1 • Adverse events were collected for the 20-week treatment period + a 2-week post-treatment follow-up, plus an additional 30 days after last dose. AE's were either observed by the investigator via physical examinations and laboratory testing and/or reported by the subject.
Nervous system disorders presyncope	0.10% 1/999 • Number of events 1 • Adverse events were collected for the 20-week treatment period + a 2-week post-treatment follow-up, plus an additional 30 days after last dose. AE's were either observed by the investigator via physical examinations and laboratory testing and/or reported by the subject.
Nervous system disorders epilepsy	0.10% 1/999 • Number of events 1 • Adverse events were collected for the 20-week treatment period + a 2-week post-treatment follow-up, plus an additional 30 days after last dose. AE's were either observed by the investigator via physical examinations and laboratory testing and/or reported by the subject.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non small cell lung cancer	0.10% 1/999 • Number of events 1 • Adverse events were collected for the 20-week treatment period + a 2-week post-treatment follow-up, plus an additional 30 days after last dose. AE's were either observed by the investigator via physical examinations and laboratory testing and/or reported by the subject.
Gastrointestinal disorders abdominal pain	0.10% 1/999 • Number of events 1 • Adverse events were collected for the 20-week treatment period + a 2-week post-treatment follow-up, plus an additional 30 days after last dose. AE's were either observed by the investigator via physical examinations and laboratory testing and/or reported by the subject.
Reproductive system and breast disorders vaginal haemhorrage	0.10% 1/999 • Number of events 1 • Adverse events were collected for the 20-week treatment period + a 2-week post-treatment follow-up, plus an additional 30 days after last dose. AE's were either observed by the investigator via physical examinations and laboratory testing and/or reported by the subject.
Injury, poisoning and procedural complications road traffic accident	0.10% 1/999 • Number of events 1 • Adverse events were collected for the 20-week treatment period + a 2-week post-treatment follow-up, plus an additional 30 days after last dose. AE's were either observed by the investigator via physical examinations and laboratory testing and/or reported by the subject.
Musculoskeletal and connective tissue disorders muscular weakness	0.10% 1/999 • Number of events 1 • Adverse events were collected for the 20-week treatment period + a 2-week post-treatment follow-up, plus an additional 30 days after last dose. AE's were either observed by the investigator via physical examinations and laboratory testing and/or reported by the subject.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) protate cancer	0.10% 1/999 • Number of events 1 • Adverse events were collected for the 20-week treatment period + a 2-week post-treatment follow-up, plus an additional 30 days after last dose. AE's were either observed by the investigator via physical examinations and laboratory testing and/or reported by the subject.
Respiratory, thoracic and mediastinal disorders asthma	0.10% 1/999 • Number of events 1 • Adverse events were collected for the 20-week treatment period + a 2-week post-treatment follow-up, plus an additional 30 days after last dose. AE's were either observed by the investigator via physical examinations and laboratory testing and/or reported by the subject.

Other adverse events

Other adverse events
Measure	Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide n=999 participants at risk Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
General disorders oedema	8.6% 86/999 • Adverse events were collected for the 20-week treatment period + a 2-week post-treatment follow-up, plus an additional 30 days after last dose. AE's were either observed by the investigator via physical examinations and laboratory testing and/or reported by the subject.
Nervous system disorders headache	5.2% 52/999 • Adverse events were collected for the 20-week treatment period + a 2-week post-treatment follow-up, plus an additional 30 days after last dose. AE's were either observed by the investigator via physical examinations and laboratory testing and/or reported by the subject.
Nervous system disorders dizziness	10.3% 103/999 • Adverse events were collected for the 20-week treatment period + a 2-week post-treatment follow-up, plus an additional 30 days after last dose. AE's were either observed by the investigator via physical examinations and laboratory testing and/or reported by the subject.

Additional Information

John Raia

Daiichi Sankyo, Inc

Phone: (973) 944-2683

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee As stated in the clinical study agreement, If identified by DSI, any of DSI's confidential information as defined herein shall be deleted...Nothing in this publication section shall be taken as giving DSI any right of editorial control over any publicartion prepared by the Study Site."
Publication restrictions are in place

Restriction type: OTHER