Trial Outcomes & Findings for An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Patients With Type II Diabetes (NCT NCT00403481)

Results Overview

Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

192 participants

Primary outcome timeframe

baseline and 12 weeks

Results posted on

2016-11-03

Participant Flow

Subjects were recruited at 24 US sites over 10 months from November 2006 to August 2007 from each physician's clientele base. Approximately 200 eligible subjects, men and women at least 18 years of age with stage I/II hypertension and stable type 2 diabetes mellitus, were to be enrolled on active treatment.

192 participants started this single arm titration study. Participants remained in their group or were titrated at 3-week intervals depending on achievement their blood pressure goals.

Participant milestones

Participant milestones
Measure	Active Treatment Period All participants started this arm with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled.
Olmesartan Medoxomil (Olm) 20 mg STARTED	192
Olmesartan Medoxomil (Olm) 20 mg COMPLETED	186
Olmesartan Medoxomil (Olm) 20 mg NOT COMPLETED	6
Olm 40 mg STARTED	182
Olm 40 mg COMPLETED	177
Olm 40 mg NOT COMPLETED	5
Olm 40 mg + Hydrochlorothiazide 12.5 mg STARTED	173
Olm 40 mg + Hydrochlorothiazide 12.5 mg COMPLETED	168
Olm 40 mg + Hydrochlorothiazide 12.5 mg NOT COMPLETED	5
Olm 40 mg + Hydrochlorothiazide 25 mg STARTED	144
Olm 40 mg + Hydrochlorothiazide 25 mg COMPLETED	142
Olm 40 mg + Hydrochlorothiazide 25 mg NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Treatment Period All participants started this arm with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled.
Olmesartan Medoxomil (Olm) 20 mg Adverse Event	1
Olmesartan Medoxomil (Olm) 20 mg Physician Decision	1
Olmesartan Medoxomil (Olm) 20 mg Protocol Violation	3
Olmesartan Medoxomil (Olm) 20 mg Withdrawal by Subject	1
Olm 40 mg Adverse Event	2
Olm 40 mg Protocol Violation	1
Olm 40 mg Withdrawal by Subject	1
Olm 40 mg Other	1
Olm 40 mg + Hydrochlorothiazide 12.5 mg Adverse Event	2
Olm 40 mg + Hydrochlorothiazide 12.5 mg Protocol Violation	1
Olm 40 mg + Hydrochlorothiazide 12.5 mg Withdrawal by Subject	1
Olm 40 mg + Hydrochlorothiazide 12.5 mg Other	1
Olm 40 mg + Hydrochlorothiazide 25 mg Withdrawal by Subject	1
Olm 40 mg + Hydrochlorothiazide 25 mg Lost to Follow-up	1

Baseline Characteristics

An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Patients With Type II Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Treatmant Arm n=192 Participants All participants started this arm with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled.
Age, Continuous	58.1 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	85 Participants n=5 Participants
Sex: Female, Male Male	107 Participants n=5 Participants
Race/Ethnicity, Customized Black/African American	43 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants
Race/Ethnicity, Customized White	145 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian/Pacific Islander	1 Participants n=5 Participants
Region of Enrollment United States	192 participants n=5 Participants
Diastolic BP	90.0 mm Hg STANDARD_DEVIATION 10.0 • n=5 Participants
Heart rate	76.4 beats/min STANDARD_DEVIATION 10.4 • n=5 Participants
Systolic BP	158.1 mm Hg STANDARD_DEVIATION 12.6 • n=5 Participants

PRIMARY outcome

Timeframe: baseline and 12 weeks

Population: A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.

Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.

Outcome measures

Outcome measures
Measure	Overall Study Population n=172 Participants
Change From Baseline to Week 12 in Systolic BP (SBP) as Measured by 24-hour ABPM.	-20.4 mm Hg Standard Error 0.88

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.

Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.

Outcome measures

Outcome measures
Measure	Overall Study Population n=172 Participants
Change From Baseline to Week 12 in Mean Daytime and Nighttime Ambulatory Blood Pressure Measurement (Systolic). Daytime	-22.3 mm Hg Standard Error 1.05
Change From Baseline to Week 12 in Mean Daytime and Nighttime Ambulatory Blood Pressure Measurement (Systolic). Nighttime	-18.8 mm Hg Standard Error 0.94

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM. Of the 172 ABPM participants, only 169 had the required measurements for this outcome analysis.

Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.

Outcome measures

Outcome measures
Measure	Overall Study Population n=169 Participants
Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 2 Hours of the Last (Week 12) 24-hour Dosing Period.	-18.6 mm Hg Standard Error 1.11

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.Of the 172 ABPM participants, only 171 had the required measurements for this outcome analysis.

Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.

Outcome measures

Outcome measures
Measure	Overall Study Population n=171 Participants
Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 4 Hours of the Last (Week 12 ) 24-hour Dosing Period.	-18.2 mm Hg Standard Error 1.00

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM. Of the 172 ABPM participants, only 171 had the required measurements

Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.

Outcome measures

Outcome measures
Measure	Overall Study Population n=171 Participants
Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 6 Hours of the Last (Week 12 ) 24-hour Dosing Period.	-18.6 mm Hg Standard Error 0.92

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.

Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.

Outcome measures

Outcome measures
Measure	Overall Study Population n=172 Participants
Change From Baseline to Week 12 in Mean 24-hour Ambulatory BP (Diastolic)	-11.1 mm Hg Standard Error 0.54

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.

Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.

Outcome measures

Outcome measures
Measure	Overall Study Population n=172 Participants
Change in Daytime and Nighttime Ambulatory Blood Pressure (Diastolic) From Baseline to Week 12 Daytime	-12.0 mm Hg Standard Error 0.68
Change in Daytime and Nighttime Ambulatory Blood Pressure (Diastolic) From Baseline to Week 12 Nighttime	-10.2 mm Hg Standard Error 0.55

SECONDARY outcome

Timeframe: baseline and 12 Weeks

Population: A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM.Of the 172 participants, only 169 had the required measurements for this outcome analysis.

Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.

Outcome measures

Outcome measures
Measure	Overall Study Population n=169 Participants
Change in Ambulatory Blood Pressure (Diastolic) From Baseline to Week 12 During the Last 2 Hours of the Last (Week 12 ) 24-hour Dosing Period.	-10.6 mm Hg Standard Error 0.78

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: A total of 192 participants started. Eighteen dropped out. All Ambulatory Blood Pressure Monitoring (ABPM) Subjects (N=172) consisted of all subjects in the efficacy cohort who had a baseline and week 12 ABPM. Of the 172 ABPM participants, only 171 had the required measurements for this outcome analysis.

Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.

Outcome measures

Outcome measures
Measure	Overall Study Population n=171 Participants
Change in Ambulatory BP (Diastolic) From Baseline to Week 12 During the Last (Week 12 ) 4 and 6 Hours of the Last 24-hour Dosing Period. 4 hours	-10.7 mm Hg Standard Error 0.66
Change in Ambulatory BP (Diastolic) From Baseline to Week 12 During the Last (Week 12 ) 4 and 6 Hours of the Last 24-hour Dosing Period. 6 hours	-10.8 mm Hg Standard Error 0.61

Adverse Events

Olmesartan 20 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Olmesartan 40 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Olmesartan 40 mg and Hydrochlorothiazide 12.5 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Olmesartan 40 mg and Hydrochlorothiazide 25 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Olmesartan 20 mg n=192 participants at risk All participants started with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled.	Olmesartan 40 mg n=182 participants at risk All participants started with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled	Olmesartan 40 mg and Hydrochlorothiazide 12.5 mg n=173 participants at risk All participants started with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled	Olmesartan 40 mg and Hydrochlorothiazide 25 mg n=144 participants at risk All participants started with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled
General disorders Death due to arteriosclerotic cardiovascular disease	0.00% 0/192 • 12 week treatment period plus 30 days after the last dose of study medication. Safety assessments included physical examination, reporting of adverse events, and changes in laboratory values. At each visit, the investigator determined whether any adverse events had occurred by evaluating the subject. Subjects were to be questioned in a general way, without asking about the occurrence of any specific symptoms.	0.00% 0/182 • 12 week treatment period plus 30 days after the last dose of study medication. Safety assessments included physical examination, reporting of adverse events, and changes in laboratory values. At each visit, the investigator determined whether any adverse events had occurred by evaluating the subject. Subjects were to be questioned in a general way, without asking about the occurrence of any specific symptoms.	0.58% 1/173 • 12 week treatment period plus 30 days after the last dose of study medication. Safety assessments included physical examination, reporting of adverse events, and changes in laboratory values. At each visit, the investigator determined whether any adverse events had occurred by evaluating the subject. Subjects were to be questioned in a general way, without asking about the occurrence of any specific symptoms.	0.00% 0/144 • 12 week treatment period plus 30 days after the last dose of study medication. Safety assessments included physical examination, reporting of adverse events, and changes in laboratory values. At each visit, the investigator determined whether any adverse events had occurred by evaluating the subject. Subjects were to be questioned in a general way, without asking about the occurrence of any specific symptoms.

Other adverse events

Other adverse events
Measure	Olmesartan 20 mg n=192 participants at risk All participants started with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled.	Olmesartan 40 mg n=182 participants at risk All participants started with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled	Olmesartan 40 mg and Hydrochlorothiazide 12.5 mg n=173 participants at risk All participants started with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled	Olmesartan 40 mg and Hydrochlorothiazide 25 mg n=144 participants at risk All participants started with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled
Musculoskeletal and connective tissue disorders Arthralgia	0.52% 1/192 • 12 week treatment period plus 30 days after the last dose of study medication. Safety assessments included physical examination, reporting of adverse events, and changes in laboratory values. At each visit, the investigator determined whether any adverse events had occurred by evaluating the subject. Subjects were to be questioned in a general way, without asking about the occurrence of any specific symptoms.	1.1% 2/182 • 12 week treatment period plus 30 days after the last dose of study medication. Safety assessments included physical examination, reporting of adverse events, and changes in laboratory values. At each visit, the investigator determined whether any adverse events had occurred by evaluating the subject. Subjects were to be questioned in a general way, without asking about the occurrence of any specific symptoms.	1.2% 2/173 • 12 week treatment period plus 30 days after the last dose of study medication. Safety assessments included physical examination, reporting of adverse events, and changes in laboratory values. At each visit, the investigator determined whether any adverse events had occurred by evaluating the subject. Subjects were to be questioned in a general way, without asking about the occurrence of any specific symptoms.	2.1% 3/144 • 12 week treatment period plus 30 days after the last dose of study medication. Safety assessments included physical examination, reporting of adverse events, and changes in laboratory values. At each visit, the investigator determined whether any adverse events had occurred by evaluating the subject. Subjects were to be questioned in a general way, without asking about the occurrence of any specific symptoms.
Infections and infestations Bronchitis	1.6% 3/192 • 12 week treatment period plus 30 days after the last dose of study medication. Safety assessments included physical examination, reporting of adverse events, and changes in laboratory values. At each visit, the investigator determined whether any adverse events had occurred by evaluating the subject. Subjects were to be questioned in a general way, without asking about the occurrence of any specific symptoms.	1.6% 3/182 • 12 week treatment period plus 30 days after the last dose of study medication. Safety assessments included physical examination, reporting of adverse events, and changes in laboratory values. At each visit, the investigator determined whether any adverse events had occurred by evaluating the subject. Subjects were to be questioned in a general way, without asking about the occurrence of any specific symptoms.	0.00% 0/173 • 12 week treatment period plus 30 days after the last dose of study medication. Safety assessments included physical examination, reporting of adverse events, and changes in laboratory values. At each visit, the investigator determined whether any adverse events had occurred by evaluating the subject. Subjects were to be questioned in a general way, without asking about the occurrence of any specific symptoms.	0.00% 0/144 • 12 week treatment period plus 30 days after the last dose of study medication. Safety assessments included physical examination, reporting of adverse events, and changes in laboratory values. At each visit, the investigator determined whether any adverse events had occurred by evaluating the subject. Subjects were to be questioned in a general way, without asking about the occurrence of any specific symptoms.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/192 • 12 week treatment period plus 30 days after the last dose of study medication. Safety assessments included physical examination, reporting of adverse events, and changes in laboratory values. At each visit, the investigator determined whether any adverse events had occurred by evaluating the subject. Subjects were to be questioned in a general way, without asking about the occurrence of any specific symptoms.	0.00% 0/182 • 12 week treatment period plus 30 days after the last dose of study medication. Safety assessments included physical examination, reporting of adverse events, and changes in laboratory values. At each visit, the investigator determined whether any adverse events had occurred by evaluating the subject. Subjects were to be questioned in a general way, without asking about the occurrence of any specific symptoms.	0.58% 1/173 • 12 week treatment period plus 30 days after the last dose of study medication. Safety assessments included physical examination, reporting of adverse events, and changes in laboratory values. At each visit, the investigator determined whether any adverse events had occurred by evaluating the subject. Subjects were to be questioned in a general way, without asking about the occurrence of any specific symptoms.	2.1% 3/144 • 12 week treatment period plus 30 days after the last dose of study medication. Safety assessments included physical examination, reporting of adverse events, and changes in laboratory values. At each visit, the investigator determined whether any adverse events had occurred by evaluating the subject. Subjects were to be questioned in a general way, without asking about the occurrence of any specific symptoms.

Additional Information

John J. Raia, R.Ph, Pharm. D.

Daiichi Sankyo

Phone: 1-877-437-7763

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If identified by Daiichi Sankyo Inc., any of DSI's confidential information, as defined to the author, shall be deleted. Nothing in our site agreement shall be taken as giving Daiichi Sankyo, Inc. any right of editorial control over any publication prepared by the study site.
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