Trial Outcomes & Findings for 18 Week Study Evaluating Safety and Efficacy of Olmesartan, Amlodipine, and Hydrochlorothiazide, in Type 2 Diabetics (NCT NCT00654745)
NCT ID: NCT00654745
Last Updated: 2010-07-13
Results Overview
Change from week 0 (baseline) in mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) after 12 weeks of active treatment. change = week 12 - week 0.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
207 participants
Primary outcome timeframe
week 0 - week 12
Results posted on
2010-07-13
Participant Flow
Subjects were recruited at 32 sites in the USA from May 12, 2008 to Jan 2, 2009 and 207 enrolled into the active treatment period. The study population consisted of subjects with controlled type 2 diabetes, not requiring insulin therapy, whose hypertension was newly diagnosed or uncontrolled on antihypertensive monotherapy or combination therapy.
Subjects began washout of anti-hypertensive medications during screening then entered placebo run-in lasting 2-3 weeks. Subjects must meet seated blood pressure (BP) criteria at 2 consecutive qualifying visits during the run-in period and satisfy mean daytime ambulatory BP criteria at baseline, one day prior to the first dose of active study drug.
Participant milestones
| Measure |
Amlodipine, Olmesartan Medoxomil, Hydrochlorothiazide
Participants receiving amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
|
|---|---|
|
Overall Study
STARTED
|
207
|
|
Overall Study
COMPLETED
|
164
|
|
Overall Study
NOT COMPLETED
|
43
|
Reasons for withdrawal
| Measure |
Amlodipine, Olmesartan Medoxomil, Hydrochlorothiazide
Participants receiving amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
|
|---|---|
|
Overall Study
Adverse Event
|
12
|
|
Overall Study
Lost to Follow-up
|
7
|
|
Overall Study
Protocol Violation
|
11
|
|
Overall Study
Withdrawal by Subject
|
10
|
|
Overall Study
poor ABPM, noncompliance, lab MAs
|
3
|
Baseline Characteristics
18 Week Study Evaluating Safety and Efficacy of Olmesartan, Amlodipine, and Hydrochlorothiazide, in Type 2 Diabetics
Baseline characteristics by cohort
| Measure |
Aml + Olm + Hctz
n=207 Participants
amlodipine (aml) + olmesartan medoxomil (olm)+ hhdrochlorothiazide (hctz) is total number enrolled. Each group is the number of participants that were titrated to that dosing regimen as per the protocol. The total number of participants of the individual groups does not (and should not) equal the total number enrolled.
|
|---|---|
|
Age Continuous
|
59.1 years
STANDARD_DEVIATION 9.50 • n=5 Participants
|
|
Sex: Female, Male
Female
|
122 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
153 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
162 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Stage of hypertension
Stage 1
|
115 participants
n=5 Participants
|
|
Stage of hypertension
Stage 2
|
92 participants
n=5 Participants
|
|
Body mass index
|
32.80 mg/m2
STANDARD_DEVIATION 5.947 • n=5 Participants
|
|
Mean 24-hour ambulatory diastolic blood pressure
|
81.6 mm Hg
STANDARD_DEVIATION 9.76 • n=5 Participants
|
|
Mean 24-hour ambulatory systolic blood pressure
|
144.4 mm Hg
STANDARD_DEVIATION 11.74 • n=5 Participants
|
|
Pulse rate
|
73.75 beats per minute
STANDARD_DEVIATION 11.909 • n=5 Participants
|
|
Seated Diastolic Blood Pressure
|
89.1 mm Hg
STANDARD_DEVIATION 10.13 • n=5 Participants
|
|
Seated Systolic Blood Pressure
|
158.8 mm Hg
STANDARD_DEVIATION 13.14 • n=5 Participants
|
|
Years with diabetes
|
6.44 years
STANDARD_DEVIATION 5.978 • n=5 Participants
|
PRIMARY outcome
Timeframe: week 0 - week 12Population: ABPM subjects analysis population included 165 subjects who received at least one dose of active study medication and provided valid ambulatory blood pressure monitoring measurements at baseline and week 12.
Change from week 0 (baseline) in mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) after 12 weeks of active treatment. change = week 12 - week 0.
Outcome measures
| Measure |
Aml + Olm + Hctz
n=165 Participants
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
|
|---|---|
|
Change From Week 0 (Baseline) in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) After 12 Weeks of Active Treatment
|
-19.9 mm Hg
Standard Error 0.76
|
SECONDARY outcome
Timeframe: week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour)24-hour mean DBP, Daytime mean DBP, Nighttime mean DBP, Last 6 hour mean DBP, Last 4 hour mean DBP, Last 2 hour mean DBP
Outcome measures
| Measure |
Aml + Olm + Hctz
n=165 Participants
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
|
|---|---|
|
Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment
24-hour mean DBP change from baseline
|
-11.2 mm Hg
Standard Error 0.50
|
|
Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment
daytime mean DBP change from baseline
|
-11.7 mm Hg
Standard Error 0.60
|
|
Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment
nighttime mean DBP change from baseline
|
-10.4 mm Hg
Standard Error 0.68
|
|
Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment
last 6 hour mean DBP change from baseline
|
-10.9 mm Hg
Standard Error 0.64
|
|
Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment
last 4 hour mean DBP change from baseline
|
-11.1 mm Hg
Standard Error 0.68
|
|
Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment
last 2 hour mean DBP change from baseline
|
-11.5 mm Hg
Standard Error 0.76
|
SECONDARY outcome
Timeframe: week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour)Daytime mean SBP, Nighttime mean SBP, Last 6 hour mean SBP, Last 4 hour mean SBP, Last 2 hour mean SBP
Outcome measures
| Measure |
Aml + Olm + Hctz
n=165 Participants
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
|
|---|---|
|
Change From Week 0 (Baseline) in Mean ABPM SBP After 12 Weeks of Active Treatment
daytime mean SBP change from baseline
|
-20.8 mm Hg
Standard Error 0.92
|
|
Change From Week 0 (Baseline) in Mean ABPM SBP After 12 Weeks of Active Treatment
nighttime mean SBP change from baseline
|
-18.5 mm Hg
Standard Error 0.95
|
|
Change From Week 0 (Baseline) in Mean ABPM SBP After 12 Weeks of Active Treatment
last 6 hours mean SBP change from baseline
|
-18.9 mm Hg
Standard Error 0.93
|
|
Change From Week 0 (Baseline) in Mean ABPM SBP After 12 Weeks of Active Treatment
last 4 hours mean SBP change from baseline
|
-19.1 mm Hg
Standard Error 1.02
|
|
Change From Week 0 (Baseline) in Mean ABPM SBP After 12 Weeks of Active Treatment
last 2 hours mean SBP change from baseline
|
-19.5 mm Hg
Standard Error 1.10
|
SECONDARY outcome
Timeframe: week 0 - weeks 3, 6, 9, 12, 15, 18Population: Number of participants changed by week. Week 3 = 201, Week 6 = 192, week 9 = 184, week 12 = 177, week 15 = 172, week 18 = 164.
change in mean SeSBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18.
Outcome measures
| Measure |
Aml + Olm + Hctz
n=201 Participants
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
|
|---|---|
|
Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks
week 6 mean SBP change from baseline
|
-17.9 mm Hg
Standard Error 0.92
|
|
Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks
week 9 mean SBP change from baseline
|
-20.0 mm Hg
Standard Error 1.10
|
|
Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks
week 12 mean SBP change from baseline
|
-23.7 mm Hg
Standard Error 1.02
|
|
Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks
week 3 mean SBP change from baseline
|
-10.3 mm Hg
Standard Error 0.87
|
|
Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks
week 15 mean SBP change from baseline
|
-28.5 mm Hg
Standard Error 1.16
|
|
Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks
week 18 mean SBP change from baseline
|
-31.1 mm Hg
Standard Error 1.13
|
SECONDARY outcome
Timeframe: week 0 - weeks 3, 6, 9, 12, 15, 18Population: Number of participants changed by week. Week 3 = 201, Week 6 = 192, week 9 = 184, week 12 = 177, week 15 = 172, week 18 = 164.
change in mean SeDBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18.
Outcome measures
| Measure |
Aml + Olm + Hctz
n=201 Participants
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
|
|---|---|
|
Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks
week 12 mean seDBP change from baseline
|
-11.2 mm Hg
Standard Error 0.64
|
|
Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks
week 15 mean seDBP change from baseline
|
-14.4 mm Hg
Standard Error 0.66
|
|
Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks
week 18 mean seDBP change from baseline
|
-15.1 mm Hg
Standard Error 0.72
|
|
Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks
week 3 mean seDBP change from baseline
|
-4.1 mm Hg
Standard Error 0.50
|
|
Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks
week 6 mean seDBP change from baseline
|
-8.2 mm Hg
Standard Error 0.60
|
|
Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks
week 9 mean seDBP change from baseline
|
-9.7 mm Hg
Standard Error 0.64
|
SECONDARY outcome
Timeframe: week 0 - week 12number of participants achieving mean 24-hour ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12
Outcome measures
| Measure |
Aml + Olm + Hctz
n=165 Participants
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
|
|---|---|
|
Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12
mean 24-hour BP <120/80
|
59 participants
|
|
Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12
mean 24-hour SBP <135
|
140 participants
|
|
Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12
mean 24-hour DBP <80
|
146 participants
|
|
Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12
mean 24-hour DBP <75
|
121 participants
|
|
Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12
mean 24-hour BP <135/85
|
140 participants
|
|
Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12
mean 24-hour BP <130/80
|
116 participants
|
|
Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12
mean 24-hour BP <125/75
|
76 participants
|
|
Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12
mean 24-hour SBP <130
|
120 participants
|
|
Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12
mean 24-hour SBP <125
|
92 participants
|
|
Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12
mean 24-hour SBP <120
|
59 participants
|
|
Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12
mean 24-hour DBP <85
|
158 participants
|
SECONDARY outcome
Timeframe: week 0 - week 12number of participants achieving mean daytime ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12
Outcome measures
| Measure |
Aml + Olm + Hctz
n=165 Participants
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
|
|---|---|
|
Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12
mean daytime BP < 135/85
|
116 participants
|
|
Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12
mean daytime BP < 130/80
|
83 participants
|
|
Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12
mean daytime BP < 125/75
|
48 participants
|
|
Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12
mean daytime BP < 120/80
|
42 participants
|
|
Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12
mean daytime SBP < 135
|
118 participants
|
|
Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12
mean daytime SBP < 130
|
94 participants
|
|
Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12
mean daytime SBP < 125
|
67 participants
|
|
Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12
mean daytime SBP < 120
|
42 participants
|
|
Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12
mean daytime DBP < 85
|
151 participants
|
|
Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12
mean daytime DBP < 80
|
124 participants
|
|
Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12
mean daytime DBP < 75
|
91 participants
|
SECONDARY outcome
Timeframe: week 0 - week 12number of participants achieving mean nighttime ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, BP\<120/70, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75, DBP\<70 at week 12
Outcome measures
| Measure |
Aml + Olm + Hctz
n=165 Participants
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
|
|---|---|
|
Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12
mean nighttime SBP < 125
|
123 participants
|
|
Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12
mean nighttime SBP < 120
|
112 participants
|
|
Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12
mean nighttime DBP < 85
|
160 participants
|
|
Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12
mean nighttime DBP < 80
|
158 participants
|
|
Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12
mean nighttime DBP < 75
|
147 participants
|
|
Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12
mean nighttime DBP < 70
|
124 participants
|
|
Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12
mean nighttime BP < 135/85
|
152 participants
|
|
Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12
mean nighttime BP < 130/80
|
137 participants
|
|
Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12
mean nighttime BP < 125/75
|
119 participants
|
|
Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12
mean nighttime BP < 120/80
|
112 participants
|
|
Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12
mean nighttime BP < 120/70
|
101 participants
|
|
Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12
mean nighttime SBP < 135
|
154 participants
|
|
Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12
mean nighttime SBP < 130
|
139 participants
|
SECONDARY outcome
Timeframe: week 0 - week 12number participants achieving mean last 6 hour ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12
Outcome measures
| Measure |
Aml + Olm + Hctz
n=165 Participants
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
|
|---|---|
|
Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12
mean last 6 hour BP < 135/85
|
135 participants
|
|
Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12
mean last 6 hour BP < 130/80
|
124 participants
|
|
Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12
mean last 6 hour SBP < 120
|
85 participants
|
|
Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12
mean last 6 hour DBP < 85
|
157 participants
|
|
Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12
mean last 6 hour DBP < 80
|
146 participants
|
|
Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12
mean last 6 hour BP < 125/75
|
101 participants
|
|
Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12
mean last 6 hour BP < 120/80
|
85 participants
|
|
Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12
mean last 6 hour SBP < 135
|
143 participants
|
|
Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12
mean last 6 hour SBP < 130
|
127 participants
|
|
Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12
mean last 6 hour SBP < 125
|
108 participants
|
|
Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12
mean last 6 hour DBP < 75
|
130 participants
|
SECONDARY outcome
Timeframe: week 0 - week 12number of participants achieving mean last 4 hour ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12
Outcome measures
| Measure |
Aml + Olm + Hctz
n=165 Participants
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
|
|---|---|
|
Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12
mean last 4 hour BP < 135/85
|
129 participants
|
|
Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12
mean last 4 hour BP < 130/80
|
107 participants
|
|
Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12
mean last 4 hour BP < 125/75
|
92 participants
|
|
Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12
mean last 4 hour BP < 120/80
|
72 participants
|
|
Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12
mean last 4 hour SBP < 135
|
131 participants
|
|
Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12
mean last 4 hour SBP < 130
|
114 participants
|
|
Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12
mean last 4 hour SBP < 125
|
102 participants
|
|
Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12
mean last 4 hour SBP < 120
|
72 participants
|
|
Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12
mean last 4 hour DBP < 85
|
150 participants
|
|
Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12
mean last 4 hour DBP < 80
|
137 participants
|
|
Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12
mean last 4 hour DBP < 75
|
120 participants
|
SECONDARY outcome
Timeframe: week 0 - week 12number of participants achieving mean last 2 hour ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12
Outcome measures
| Measure |
Aml + Olm + Hctz
n=165 Participants
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
|
|---|---|
|
Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12
mean last 2 hour SBP < 120
|
51 participants
|
|
Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12
mean last 2 hour DBP < 85
|
145 participants
|
|
Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12
mean last 2 hour BP < 135/85
|
110 participants
|
|
Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12
mean last 2 hour BP < 130/80
|
85 participants
|
|
Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12
mean last 2 hour BP < 125/75
|
63 participants
|
|
Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12
mean last 2 hour BP < 120/80
|
49 participants
|
|
Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12
mean last 2 hour SBP < 135
|
115 participants
|
|
Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12
mean last 2 hour SBP < 130
|
92 participants
|
|
Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12
mean last 2 hour SBP < 125
|
76 participants
|
|
Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12
mean last 2 hour DBP < 80
|
125 participants
|
|
Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12
mean last 2 hour DBP < 75
|
94 participants
|
SECONDARY outcome
Timeframe: week 0 - week 3number of participants achieving seated systolic and diastolic blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 3
Outcome measures
| Measure |
Aml + Olm + Hctz
n=201 Participants
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
|
|---|---|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3
mean BP < 120/80
|
2 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3
mean SBP < 135
|
41 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3
mean SBP < 130
|
17 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3
mean SBP < 125
|
9 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3
mean SBP < 120
|
2 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3
mean DBP < 85
|
99 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3
mean DBP < 80
|
58 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3
mean DBP < 75
|
29 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3
mean BP < 135/85
|
31 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3
mean BP < 130/80
|
10 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3
mean BP < 125/75
|
4 participants
|
SECONDARY outcome
Timeframe: week 0 - week 6number of participants achieving seated systolic and diastolic blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 6
Outcome measures
| Measure |
Aml + Olm + Hctz
n=192 Participants
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
|
|---|---|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6
mean BP < 135/85
|
61 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6
mean BP < 130/80
|
36 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6
mean BP < 125/75
|
18 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6
mean BP < 120/80
|
13 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6
mean SBP < 135
|
73 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6
mean SBP < 130
|
48 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6
mean SBP < 125
|
31 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6
mean SBP < 120
|
14 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6
mean DBP < 85
|
127 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6
mean DBP < 80
|
91 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6
mean DBP < 75
|
48 participants
|
SECONDARY outcome
Timeframe: week 0 - week 9number of participants achieving seated systolic and diastolic blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 9
Outcome measures
| Measure |
Aml + Olm + Hctz
n=184 Participants
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
|
|---|---|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9
mean BP < 135/85
|
76 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9
mean BP < 130/80
|
47 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9
mean BP < 125/75
|
25 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9
mean BP < 120/80
|
19 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9
mean SBP < 135
|
82 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9
mean SBP < 130
|
61 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9
mean SBP < 125
|
41 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9
mean SBP < 120
|
20 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9
mean DBP < 85
|
132 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9
mean DBP < 80
|
95 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9
mean DBP < 75
|
64 participants
|
SECONDARY outcome
Timeframe: week 0 - week 12number of participants achieving seated systolic and diastolic blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12
Outcome measures
| Measure |
Aml + Olm + Hctz
n=177 Participants
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
|
|---|---|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12
mean BP < 135/85
|
86 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12
mean BP < 125/75
|
33 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12
mean BP < 120/80
|
28 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12
mean SBP < 135
|
93 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12
mean SBP < 130
|
70 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12
mean SBP < 125
|
46 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12
mean SBP < 120
|
28 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12
mean DBP < 85
|
134 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12
mean DBP < 80
|
105 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12
mean DBP < 75
|
74 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12
mean BP < 130/80
|
61 participants
|
SECONDARY outcome
Timeframe: week 0 - week 15number of participants achieving seated systolic and diastolic blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 15
Outcome measures
| Measure |
Aml + Olm + Hctz
n=172 Participants
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
|
|---|---|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15
mean BP < 125/75
|
51 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15
mean BP < 120/80
|
45 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15
mean DBP < 75
|
96 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15
mean BP < 135/85
|
114 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15
mean BP < 130/80
|
83 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15
mean SBP < 135
|
116 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15
mean SBP < 130
|
95 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15
mean SBP < 125
|
69 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15
mean SBP < 120
|
48 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15
mean DBP < 85
|
153 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15
mean DBP < 80
|
122 participants
|
SECONDARY outcome
Timeframe: week 0 - week 18number of participants achieving seated systolic and diastolic blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 18
Outcome measures
| Measure |
Aml + Olm + Hctz
n=164 Participants
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
|
|---|---|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18
mean BP < 135/85
|
117 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18
mean BP < 130/80
|
87 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18
mean BP < 125/75
|
56 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18
mean BP < 120/80
|
49 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18
mean SBP < 135
|
123 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18
mean SBP < 130
|
101 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18
mean SBP < 125
|
74 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18
mean SBP < 120
|
51 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18
mean DBP < 85
|
147 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18
mean DBP < 80
|
128 participants
|
|
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18
mean DBP < 75
|
94 participants
|
SECONDARY outcome
Timeframe: week 0 - week 12number of participants achieving mean 24 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12
Outcome measures
| Measure |
Aml + Olm + Hctz
n=165 Participants
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
|
|---|---|
|
Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean 24-hour SBP reduction =<15 mm Hg
|
50 participants
|
|
Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean 24-hour SBP reduction >15 & =<30 mm Hg
|
91 participants
|
|
Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean 24-hour SBP reduction >30 & =<45 mm Hg
|
22 participants
|
|
Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean 24-hour DBP reduction >15 & =<20 mm Hg
|
31 participants
|
|
Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean 24-hour DBP reduction >20 mm Hg
|
15 participants
|
|
Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean 24-hour SBP reduction >45 mm Hg
|
2 participants
|
|
Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean 24-hour DBP reduction =<10 mm Hg
|
72 participants
|
|
Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean 24-hour DBP reduction >10 & =<15 mm Hg
|
47 participants
|
SECONDARY outcome
Timeframe: week 0 - week 12number of participants achieving mean daytime ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12
Outcome measures
| Measure |
Aml + Olm + Hctz
n=165 Participants
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
|
|---|---|
|
Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean daytime SBP reduction =<15 mm Hg
|
47 participants
|
|
Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean daytime SBP reduction >15 & =<30 mm Hg
|
84 participants
|
|
Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean daytime DBP reduction =<10 mm Hg
|
68 participants
|
|
Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean daytime DBP reduction >10 & =<15 mm Hg
|
41 participants
|
|
Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean daytime DBP reduction >15 & =<20 mm Hg
|
33 participants
|
|
Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean daytime SBP reduction >30 & =<45 mm Hg
|
31 participants
|
|
Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean daytime SBP reduction >45 mm Hg
|
3 participants
|
|
Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean daytime DBP reduction >20 mm Hg
|
23 participants
|
SECONDARY outcome
Timeframe: week 0 - week 12number of participants achieving mean nighttime ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12
Outcome measures
| Measure |
Aml + Olm + Hctz
n=165 Participants
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
|
|---|---|
|
Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean nighttime SBP reduction >15 & =<30 mm Hg
|
79 participants
|
|
Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean nighttime SBP reduction >30 & =<45 mm Hg
|
21 participants
|
|
Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean nighttime SBP reduction >45 mm Hg
|
5 participants
|
|
Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean nighttime DBP reduction =<10 mm Hg
|
80 participants
|
|
Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean nighttime SBP reduction =<15 mm Hg
|
60 participants
|
|
Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean nighttime SBP reduction >10 & =<15 mm Hg
|
41 participants
|
|
Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean nighttime SBP reduction >15 & =<20 mm Hg
|
21 participants
|
|
Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean nighttime DBP reduction >20 mm Hg
|
23 participants
|
SECONDARY outcome
Timeframe: week 0 - week 12number of participants achieving mean last 6 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12
Outcome measures
| Measure |
Aml + Olm + Hctz
n=165 Participants
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
|
|---|---|
|
Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean last 6 hour SBP reduction >30 & =<45 mm Hg
|
23 participants
|
|
Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean last 6 hour SBP reduction >45 mm Hg
|
5 participants
|
|
Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean last 6 hour DBP reduction =<10 mm Hg
|
76 participants
|
|
Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean last 6 hour DBP reduction >10 & =<15 mm Hg
|
41 participants
|
|
Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean last 6 hour SBP reduction =<15 mm Hg
|
61 participants
|
|
Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean last 6 hour SBP reduction >15 & =<30 mm Hg
|
76 participants
|
|
Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean last 6 hour DBP reduction >15 & =<20 mm Hg
|
27 participants
|
|
Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean last 6 hour DBP reduction >20 mm Hg
|
21 participants
|
SECONDARY outcome
Timeframe: week 0 - week 12number of participants achieving mean last 4 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12
Outcome measures
| Measure |
Aml + Olm + Hctz
n=165 Participants
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
|
|---|---|
|
Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions
mean last 4 hour SBP reduction >15 & =<30 mm Hg
|
65 participants
|
|
Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions
mean last 4 hour SBP reduction >30 & =<45 mm Hg
|
28 participants
|
|
Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions
mean last 4 hour DBP reduction >15 & =<20 mm Hg
|
25 participants
|
|
Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions
mean last 4 hour DBP reduction >20 mm Hg
|
28 participants
|
|
Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions
mean last 4 hour SBP reduction =<15 mm Hg
|
67 participants
|
|
Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions
mean last 4 hour SBP reduction >45 mm Hg
|
5 participants
|
|
Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions
mean last 4 hour DBP reduction =<10 mm Hg
|
76 participants
|
|
Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions
mean last 4 hour DBP reduction >10 & =<15 mm Hg
|
36 participants
|
SECONDARY outcome
Timeframe: week 0 - week 12number of participants achieving mean last 2 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12
Outcome measures
| Measure |
Aml + Olm + Hctz
n=165 Participants
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
|
|---|---|
|
Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean last 2 hour SBP reduction =<15 mm Hg
|
63 participants
|
|
Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean last 2 hour SBP reduction >15 & =<30 mm Hg
|
62 participants
|
|
Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean last 2 hour SBP reduction >30 & =<45 mm Hg
|
35 participants
|
|
Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean last 2 hour DBP reduction =<10 mm Hg
|
77 participants
|
|
Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean last 2 hour DBP reduction >10 & =<15 mm Hg
|
28 participants
|
|
Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean last 2 hour DBP reduction >15 & =<20 mm Hg
|
29 participants
|
|
Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean last 2 hour SBP reduction >45 mm Hg
|
5 participants
|
|
Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
mean last 2 hour DBP reduction >20 mm Hg
|
31 participants
|
SECONDARY outcome
Timeframe: week 0 - week 3number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 3
Outcome measures
| Measure |
Aml + Olm + Hctz
n=201 Participants
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
|
|---|---|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3
mean seated SBP reduction =<15 mm Hg
|
131 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3
mean seated SBP reduction >15 & =<30 mm Hg
|
62 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3
mean seated SBP reduction >30 & =<45 mm Hg
|
6 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3
mean seated SBP reduction >45 mm Hg
|
2 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3
mean seated DBP reduction =<10 mm Hg
|
163 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3
mean seated DBP reduction >10 & =<15 mm Hg
|
25 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3
mean seated DBP reduction >15 & =<20 mm Hg
|
10 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3
mean seated DBP reduction >20 mm Hg
|
3 participants
|
SECONDARY outcome
Timeframe: week 0 - week 6number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 6
Outcome measures
| Measure |
Aml + Olm + Hctz
n=192 Participants
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
|
|---|---|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6
mean seated SBP reduction >15 & =<30 mm Hg
|
90 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6
mean seated DBP reduction >15 & =<20 mm Hg
|
24 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6
mean seated DBP reduction >20 mm Hg
|
15 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6
mean seated DBP reduction =<10 mm Hg
|
120 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6
mean seated DBP reduction >10 & =<15 mm Hg
|
33 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6
mean seated SBP reduction =<15 mm Hg
|
69 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6
mean seated SBP reduction >30 & =<45 mm Hg
|
31 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6
mean seated SBP reduction >45 mm Hg
|
2 participants
|
SECONDARY outcome
Timeframe: week 0 - week 9number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 9
Outcome measures
| Measure |
Aml + Olm + Hctz
n=184 Participants
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
|
|---|---|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9
mean seated SBP reduction =<15 mm Hg
|
72 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9
mean seated SBP reduction >15 & =<30 mm Hg
|
69 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9
mean seated SBP reduction >30 & =<45 mm Hg
|
34 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9
mean seated DBP reduction =<10 mm Hg
|
100 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9
mean seated DBP reduction >15 & =<20 mm Hg
|
18 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9
mean seated SBP reduction >45 mm Hg
|
9 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9
mean seated DBP reduction >10 & =<15 mm Hg
|
43 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9
mean seated DBP reduction >20 mm Hg
|
23 participants
|
SECONDARY outcome
Timeframe: week 0 - week 12number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12
Outcome measures
| Measure |
Aml + Olm + Hctz
n=177 Participants
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
|
|---|---|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12
mean seated SBP reduction >30 & =<45 mm Hg
|
45 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12
mean seated DBP reduction >15 & =<20 mm Hg
|
27 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12
mean seated DBP reduction >20 mm Hg
|
23 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12
mean seated SBP reduction =<15 mm Hg
|
48 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12
mean seated SBP reduction >15 & =<30 mm Hg
|
73 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12
mean seated SBP reduction >45 mm Hg
|
11 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12
mean seated DBP reduction =<10 mm Hg
|
85 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12
mean seated DBP reduction >10 & =<15 mm Hg
|
42 participants
|
SECONDARY outcome
Timeframe: week 0 - week 15number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 15
Outcome measures
| Measure |
Aml + Olm + Hctz
n=172 Participants
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
|
|---|---|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15
mean seated SBP reduction =<15 mm Hg
|
31 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15
mean seated SBP reduction >15 & =<30 mm Hg
|
66 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15
mean seated SBP reduction >30 & =<45 mm Hg
|
55 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15
mean seated SBP reduction >45 mm Hg
|
20 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15
mean seated DBP reduction =<10 mm Hg
|
52 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15
mean seated DBP reduction >10 & =<15 mm Hg
|
45 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15
mean seated DBP reduction >15 & =<20 mm Hg
|
32 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15
mean seated DBP reduction >20 mm Hg
|
43 participants
|
SECONDARY outcome
Timeframe: week 0 - week 18number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 18
Outcome measures
| Measure |
Aml + Olm + Hctz
n=164 Participants
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
|
|---|---|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18
mean seated SBP reduction >30 & =<45 mm Hg
|
64 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18
mean seated SBP reduction >45 mm Hg
|
25 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18
mean seated DBP reduction =<10 mm Hg
|
50 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18
mean seated DBP reduction >10 & =<15 mm Hg
|
33 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18
mean seated DBP reduction >15 & =<20 mm Hg
|
29 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18
mean seated DBP reduction >20 mm Hg
|
52 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18
mean seated SBP reduction =<15 mm Hg
|
22 participants
|
|
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18
mean seated SBP reduction >15 & =<30 mm Hg
|
53 participants
|
Adverse Events
ALL - Aml + Olm + Hctz
Serious events: 4 serious events
Other events: 80 other events
Deaths: 0 deaths
Start - Amlodipine 5 mg
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Titration 1 - Amlodipine 5 mg / Olmesartan 20 mg
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Titration 2 - Amlodipine 5 mg / Olmesartan 40 mg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Titration 3 - Amlodipine 10 mg / Olmesartan 40 mg
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Titration 4 Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 12.5 mg
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Titration 5 - Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 25 mg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ALL - Aml + Olm + Hctz
n=207 participants at risk
Summary of ALL participants receiving amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
|
Start - Amlodipine 5 mg
n=207 participants at risk
All participants started trial on Amlodipine 5 mg.
|
Titration 1 - Amlodipine 5 mg / Olmesartan 20 mg
n=195 participants at risk
Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
|
Titration 2 - Amlodipine 5 mg / Olmesartan 40 mg
n=177 participants at risk
Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
|
Titration 3 - Amlodipine 10 mg / Olmesartan 40 mg
n=167 participants at risk
Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
|
Titration 4 Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 12.5 mg
n=146 participants at risk
Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
|
Titration 5 - Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 25 mg
n=101 participants at risk
Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
pneumonia
|
0.48%
1/207 • Number of events 1
|
0.00%
0/207
|
0.00%
0/195
|
0.00%
0/177
|
0.00%
0/167
|
0.00%
0/146
|
0.99%
1/101 • Number of events 1
|
|
Metabolism and nutrition disorders
hyperkalaemia
|
0.48%
1/207 • Number of events 1
|
0.00%
0/207
|
0.00%
0/195
|
0.00%
0/177
|
0.00%
0/167
|
0.68%
1/146 • Number of events 1
|
0.00%
0/101
|
|
Nervous system disorders
presyncope
|
0.48%
1/207 • Number of events 1
|
0.00%
0/207
|
0.00%
0/195
|
0.00%
0/177
|
0.00%
0/167
|
0.68%
1/146 • Number of events 1
|
0.00%
0/101
|
|
Respiratory, thoracic and mediastinal disorders
chronic obstructive pulmonary disease
|
0.48%
1/207 • Number of events 1
|
0.00%
0/207
|
0.00%
0/195
|
0.56%
1/177 • Number of events 1
|
0.00%
0/167
|
0.00%
0/146
|
0.99%
1/101 • Number of events 1
|
Other adverse events
| Measure |
ALL - Aml + Olm + Hctz
n=207 participants at risk
Summary of ALL participants receiving amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
|
Start - Amlodipine 5 mg
n=207 participants at risk
All participants started trial on Amlodipine 5 mg.
|
Titration 1 - Amlodipine 5 mg / Olmesartan 20 mg
n=195 participants at risk
Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
|
Titration 2 - Amlodipine 5 mg / Olmesartan 40 mg
n=177 participants at risk
Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
|
Titration 3 - Amlodipine 10 mg / Olmesartan 40 mg
n=167 participants at risk
Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
|
Titration 4 Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 12.5 mg
n=146 participants at risk
Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
|
Titration 5 - Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 25 mg
n=101 participants at risk
Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
anaemia
|
3.4%
7/207 • Number of events 7
|
0.00%
0/207
|
0.00%
0/195
|
0.00%
0/177
|
2.4%
4/167 • Number of events 4
|
0.68%
1/146 • Number of events 1
|
2.0%
2/101 • Number of events 2
|
|
General disorders
oedema peripheral
|
9.7%
20/207 • Number of events 20
|
3.4%
7/207 • Number of events 7
|
1.5%
3/195 • Number of events 3
|
1.1%
2/177 • Number of events 2
|
4.2%
7/167 • Number of events 7
|
0.68%
1/146 • Number of events 1
|
0.00%
0/101
|
|
Infections and infestations
upper respiratory tract infection
|
5.3%
11/207 • Number of events 11
|
0.00%
0/207
|
1.0%
2/195 • Number of events 2
|
1.7%
3/177 • Number of events 3
|
1.8%
3/167 • Number of events 3
|
2.1%
3/146 • Number of events 3
|
0.00%
0/101
|
|
Infections and infestations
bronchitis
|
2.4%
5/207 • Number of events 5
|
0.48%
1/207 • Number of events 1
|
1.0%
2/195 • Number of events 2
|
0.00%
0/177
|
0.60%
1/167 • Number of events 1
|
0.68%
1/146 • Number of events 1
|
0.00%
0/101
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
2.4%
5/207 • Number of events 5
|
0.48%
1/207 • Number of events 1
|
1.0%
2/195 • Number of events 2
|
0.56%
1/177 • Number of events 1
|
0.00%
0/167
|
0.68%
1/146 • Number of events 1
|
0.00%
0/101
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
2.4%
5/207 • Number of events 5
|
0.48%
1/207 • Number of events 1
|
1.5%
3/195 • Number of events 3
|
0.00%
0/177
|
0.60%
1/167 • Number of events 1
|
0.00%
0/146
|
0.00%
0/101
|
|
Nervous system disorders
dizziness
|
5.8%
12/207 • Number of events 12
|
1.4%
3/207 • Number of events 3
|
0.51%
1/195 • Number of events 1
|
1.1%
2/177 • Number of events 2
|
0.60%
1/167 • Number of events 1
|
3.4%
5/146 • Number of events 5
|
0.00%
0/101
|
|
Nervous system disorders
headache
|
2.9%
6/207 • Number of events 6
|
1.4%
3/207 • Number of events 3
|
0.00%
0/195
|
0.00%
0/177
|
1.2%
2/167 • Number of events 2
|
0.00%
0/146
|
0.99%
1/101 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
2.4%
5/207 • Number of events 5
|
0.00%
0/207
|
0.51%
1/195 • Number of events 1
|
1.1%
2/177 • Number of events 2
|
1.2%
2/167 • Number of events 2
|
0.00%
0/146
|
0.00%
0/101
|
|
Vascular disorders
hypotension
|
1.9%
4/207 • Number of events 4
|
0.00%
0/207
|
0.51%
1/195 • Number of events 1
|
0.00%
0/177
|
0.00%
0/167
|
1.4%
2/146 • Number of events 2
|
0.99%
1/101 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reflects the following restrictive language in the Clinical Study Agreements: "If identified by Daiichi Sankyo Inc. (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 publication prepared by the Study Site."
- Publication restrictions are in place
Restriction type: OTHER