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Trial record 57 of 134 for:    OLMESARTAN

18 Week Study Evaluating Safety and Efficacy of Olmesartan, Amlodipine, and Hydrochlorothiazide, in Type 2 Diabetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00654745
Recruitment Status : Completed
First Posted : April 9, 2008
Results First Posted : July 2, 2010
Last Update Posted : July 13, 2010
Sponsor:
Information provided by:
Daiichi Sankyo, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Type 2 Diabetes
Hypertension
Interventions Drug: Amlodipine
Drug: amlodipine / olmesartan medoxomil combination
Drug: Hydrochlorothiazide
Enrollment 207
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Amlodipine, Olmesartan Medoxomil, Hydrochlorothiazide
Hide Arm/Group Description Participants receiving amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Period Title: Overall Study
Started 207 [1]
Completed 164
Not Completed 43
Reason Not Completed
Adverse Event             12
Lost to Follow-up             7
Protocol Violation             11
Withdrawal by Subject             10
poor ABPM, noncompliance, lab MAs             3
[1]
This is single group study in which subjects were titrated to the next of 7 arms if BP goal not met.
Arm/Group Title Aml + Olm + Hctz
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 207
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 207 participants
59.1  (9.50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 207 participants
Female
122
  58.9%
Male
85
  41.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 207 participants
Hispanic or Latino
54
  26.1%
Not Hispanic or Latino
153
  73.9%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 207 participants
American Indian or Alaska Native
1
   0.5%
Asian
8
   3.9%
Native Hawaiian or Other Pacific Islander
1
   0.5%
Black or African American
35
  16.9%
White
162
  78.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Stage of hypertension   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 207 participants
Stage 1 115
Stage 2 92
[1]
Measure Description: Stage 1 or Stage 2 Hypertension. Stage 1 = Blood pressure > 140/90 mm Hg. Stage 2 = systolic >160 mm Hg or diastolic > 100 mm Hg
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Mg/m2
Number Analyzed 207 participants
32.80  (5.947)
Mean 24-hour ambulatory diastolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 207 participants
81.6  (9.76)
Mean 24-hour ambulatory systolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 207 participants
144.4  (11.74)
Pulse rate  
Mean (Standard Deviation)
Unit of measure:  Beats per minute
Number Analyzed 207 participants
73.75  (11.909)
Seated Diastolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 207 participants
89.1  (10.13)
Seated Systolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 207 participants
158.8  (13.14)
Years with diabetes  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 207 participants
6.44  (5.978)
1.Primary Outcome
Title Change From Week 0 (Baseline) in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) After 12 Weeks of Active Treatment
Hide Description 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.
Time Frame week 0 - week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Aml + Olm + Hctz
Hide Arm/Group Description:
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Overall Number of Participants Analyzed 165
Mean (Standard Error)
Unit of Measure: mm Hg
-19.9  (0.76)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aml + Olm + Hctz
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -19.9
Confidence Interval (2-Sided) 95%
-21.5 to -18.4
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment
Hide Description 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
Time Frame week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aml + Olm + Hctz
Hide Arm/Group Description:
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Overall Number of Participants Analyzed 165
Mean (Standard Error)
Unit of Measure: mm Hg
24-hour mean DBP change from baseline -11.2  (0.50)
daytime mean DBP change from baseline -11.7  (0.60)
nighttime mean DBP change from baseline -10.4  (0.68)
last 6 hour mean DBP change from baseline -10.9  (0.64)
last 4 hour mean DBP change from baseline -11.1  (0.68)
last 2 hour mean DBP change from baseline -11.5  (0.76)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aml + Olm + Hctz
Comments Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments 24-hour mean DBP change from baseline to week 12.
Method t-test, 2 sided
Comments standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -11.2
Confidence Interval (2-Sided) 95%
-12.2 to -10.3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Aml + Olm + Hctz
Comments Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments daytime mean DBP change from baseline to week 12.
Method t-test, 2 sided
Comments standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -11.7
Confidence Interval (2-Sided) 95%
-12.9 to -10.5
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Aml + Olm + Hctz
Comments Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments nighttime mean DBP change from baseline to week 12.
Method t-test, 2 sided
Comments standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -10.4
Confidence Interval (2-Sided) 95%
-11.7 to -9.0
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Aml + Olm + Hctz
Comments Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments last 6 hours mean DBP change from baseline to week 12.
Method t-test, 2 sided
Comments standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -10.9
Confidence Interval (2-Sided) 95%
-12.2 to -9.7
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Aml + Olm + Hctz
Comments Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments last 4 hours mean DBP change from baseline to week 12.
Method t-test, 2 sided
Comments standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -11.1
Confidence Interval (2-Sided) 95%
-12.4 to -9.8
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Aml + Olm + Hctz
Comments Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments last 2 hours mean DBP change from baseline to week 12.
Method t-test, 2 sided
Comments standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -11.5
Confidence Interval (2-Sided) 95%
-13.1 to -10.0
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Week 0 (Baseline) in Mean ABPM SBP After 12 Weeks of Active Treatment
Hide Description Daytime mean SBP, Nighttime mean SBP, Last 6 hour mean SBP, Last 4 hour mean SBP, Last 2 hour mean SBP
Time Frame week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aml + Olm + Hctz
Hide Arm/Group Description:
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Overall Number of Participants Analyzed 165
Mean (Standard Error)
Unit of Measure: mm Hg
daytime mean SBP change from baseline -20.8  (0.92)
nighttime mean SBP change from baseline -18.5  (0.95)
last 6 hours mean SBP change from baseline -18.9  (0.93)
last 4 hours mean SBP change from baseline -19.1  (1.02)
last 2 hours mean SBP change from baseline -19.5  (1.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aml + Olm + Hctz
Comments Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments daytime mean SBP change from baseline to week 12.
Method t-test, 2 sided
Comments standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -20.8
Confidence Interval (2-Sided) 95%
-22.6 to -18.9
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Aml + Olm + Hctz
Comments Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments nighttime mean SBP change from baseline to week 12.
Method t-test, 2 sided
Comments standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -18.5
Confidence Interval (2-Sided) 95%
-20.4 to -16.6
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Aml + Olm + Hctz
Comments Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments last 6 hours mean SBP change from baseline to week 12.
Method t-test, 2 sided
Comments standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -18.9
Confidence Interval (2-Sided) 95%
-20.7 to -17.0
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Aml + Olm + Hctz
Comments Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments last 4 hours mean SBP change from baseline to week 12.
Method t-test, 2 sided
Comments standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -19.1
Confidence Interval (2-Sided) 95%
-21.1 to -17.1
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Aml + Olm + Hctz
Comments Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments last 2 hours mean SBP change from baseline to week 12.
Method t-test, 2 sided
Comments standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -19.5
Confidence Interval (2-Sided) 95%
-21.7 to -17.4
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks
Hide Description change in mean SeSBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18.
Time Frame week 0 - weeks 3, 6, 9, 12, 15, 18
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants changed by week. Week 3 = 201, Week 6 = 192, week 9 = 184, week 12 = 177, week 15 = 172, week 18 = 164.
Arm/Group Title Aml + Olm + Hctz
Hide Arm/Group Description:
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Overall Number of Participants Analyzed 201
Mean (Standard Error)
Unit of Measure: mm Hg
week 3 mean SBP change from baseline -10.3  (0.87)
week 6 mean SBP change from baseline -17.9  (0.92)
week 9 mean SBP change from baseline -20.0  (1.10)
week 12 mean SBP change from baseline -23.7  (1.02)
week 15 mean SBP change from baseline -28.5  (1.16)
week 18 mean SBP change from baseline -31.1  (1.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aml + Olm + Hctz
Comments Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Change in mean seated systolic blood pressure from baseline to week 3.
Method t-test, 2 sided
Comments standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -10.3
Confidence Interval (2-Sided) 95%
-12.0 to -8.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Aml + Olm + Hctz
Comments Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Change in mean seated systolic blood pressure from baseline to week 6.
Method t-test, 2 sided
Comments standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -17.9
Confidence Interval (2-Sided) 95%
-19.8 to -16.1
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Aml + Olm + Hctz
Comments Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Change in mean seated systolic blood pressure from baseline to week 9
Method t-test, 2 sided
Comments standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -20.0
Confidence Interval (2-Sided) 95%
-22.2 to -17.8
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Aml + Olm + Hctz
Comments Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Change in mean seated systolic blood pressure from baseline to week 12
Method t-test, 2 sided
Comments standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -23.7
Confidence Interval (2-Sided) 95%
-25.7 to -21.7
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Aml + Olm + Hctz
Comments Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Change in mean seated systolic blood pressure from baseline to week 15
Method t-test, 2 sided
Comments standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -28.5
Confidence Interval (2-Sided) 95%
-30.8 to -26.2
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Aml + Olm + Hctz
Comments Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Change in mean seated systolic blood pressure from baseline to week 18
Method t-test, 2 sided
Comments standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -31.1
Confidence Interval (2-Sided) 95%
-33.3 to -28.8
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks
Hide Description change in mean SeDBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18.
Time Frame week 0 - weeks 3, 6, 9, 12, 15, 18
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants changed by week. Week 3 = 201, Week 6 = 192, week 9 = 184, week 12 = 177, week 15 = 172, week 18 = 164.
Arm/Group Title Aml + Olm + Hctz
Hide Arm/Group Description:
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Overall Number of Participants Analyzed 201
Mean (Standard Error)
Unit of Measure: mm Hg
week 3 mean seDBP change from baseline -4.1  (0.50)
week 6 mean seDBP change from baseline -8.2  (0.60)
week 9 mean seDBP change from baseline -9.7  (0.64)
week 12 mean seDBP change from baseline -11.2  (0.64)
week 15 mean seDBP change from baseline -14.4  (0.66)
week 18 mean seDBP change from baseline -15.1  (0.72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aml + Olm + Hctz
Comments Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Change in mean seated diastolic blood pressure from baseline to week 3.
Method t-test, 2 sided
Comments standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.1
Confidence Interval (2-Sided) 95%
-5.1 to -3.1
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Aml + Olm + Hctz
Comments Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Change in mean seated diastolic blood pressure from baseline to week 6
Method t-test, 2 sided
Comments standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -8.2
Confidence Interval (2-Sided) 95%
-9.4 to -7.1
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Aml + Olm + Hctz
Comments Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Change in mean seated diastolic blood pressure from baseline to week 9
Method t-test, 2 sided
Comments standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -9.7
Confidence Interval (2-Sided) 95%
-10.9 to -8.4
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Aml + Olm + Hctz
Comments Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Change in mean seated diastolic blood pressure from baseline to week 12
Method t-test, 2 sided
Comments standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -11.2
Confidence Interval (2-Sided) 95%
-12.5 to -9.9
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Aml + Olm + Hctz
Comments Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Change in mean seated diastolic blood pressure from baseline to week 15
Method t-test, 2 sided
Comments standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -14.4
Confidence Interval (2-Sided) 95%
-15.7 to -13.1
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Aml + Olm + Hctz
Comments Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Change in mean seated diastolic blood pressure from baseline to week 18
Method t-test, 2 sided
Comments standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -15.1
Confidence Interval (2-Sided) 95%
-16.5 to -13.6
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12
Hide Description number 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
Time Frame week 0 - week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aml + Olm + Hctz
Hide Arm/Group Description:
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Overall Number of Participants Analyzed 165
Measure Type: Number
Unit of Measure: participants
mean 24-hour BP <135/85 140
mean 24-hour BP <130/80 116
mean 24-hour BP <125/75 76
mean 24-hour BP <120/80 59
mean 24-hour SBP <135 140
mean 24-hour SBP <130 120
mean 24-hour SBP <125 92
mean 24-hour SBP <120 59
mean 24-hour DBP <85 158
mean 24-hour DBP <80 146
mean 24-hour DBP <75 121
7.Secondary Outcome
Title Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12
Hide Description number 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
Time Frame week 0 - week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aml + Olm + Hctz
Hide Arm/Group Description:
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Overall Number of Participants Analyzed 165
Measure Type: Number
Unit of Measure: participants
mean daytime BP < 135/85 116
mean daytime BP < 130/80 83
mean daytime BP < 125/75 48
mean daytime BP < 120/80 42
mean daytime SBP < 135 118
mean daytime SBP < 130 94
mean daytime SBP < 125 67
mean daytime SBP < 120 42
mean daytime DBP < 85 151
mean daytime DBP < 80 124
mean daytime DBP < 75 91
8.Secondary Outcome
Title Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12
Hide Description number 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
Time Frame week 0 - week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aml + Olm + Hctz
Hide Arm/Group Description:
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Overall Number of Participants Analyzed 165
Measure Type: Number
Unit of Measure: participants
mean nighttime BP < 135/85 152
mean nighttime BP < 130/80 137
mean nighttime BP < 125/75 119
mean nighttime BP < 120/80 112
mean nighttime BP < 120/70 101
mean nighttime SBP < 135 154
mean nighttime SBP < 130 139
mean nighttime SBP < 125 123
mean nighttime SBP < 120 112
mean nighttime DBP < 85 160
mean nighttime DBP < 80 158
mean nighttime DBP < 75 147
mean nighttime DBP < 70 124
9.Secondary Outcome
Title Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12
Hide Description number 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
Time Frame week 0 - week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aml + Olm + Hctz
Hide Arm/Group Description:
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Overall Number of Participants Analyzed 165
Measure Type: Number
Unit of Measure: participants
mean last 6 hour BP < 135/85 135
mean last 6 hour BP < 130/80 124
mean last 6 hour BP < 125/75 101
mean last 6 hour BP < 120/80 85
mean last 6 hour SBP < 135 143
mean last 6 hour SBP < 130 127
mean last 6 hour SBP < 125 108
mean last 6 hour SBP < 120 85
mean last 6 hour DBP < 85 157
mean last 6 hour DBP < 80 146
mean last 6 hour DBP < 75 130
10.Secondary Outcome
Title Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12
Hide Description number 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
Time Frame week 0 - week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aml + Olm + Hctz
Hide Arm/Group Description:
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Overall Number of Participants Analyzed 165
Measure Type: Number
Unit of Measure: participants
mean last 4 hour BP < 135/85 129
mean last 4 hour BP < 130/80 107
mean last 4 hour BP < 125/75 92
mean last 4 hour BP < 120/80 72
mean last 4 hour SBP < 135 131
mean last 4 hour SBP < 130 114
mean last 4 hour SBP < 125 102
mean last 4 hour SBP < 120 72
mean last 4 hour DBP < 85 150
mean last 4 hour DBP < 80 137
mean last 4 hour DBP < 75 120
11.Secondary Outcome
Title Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12
Hide Description number 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
Time Frame week 0 - week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aml + Olm + Hctz
Hide Arm/Group Description:
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Overall Number of Participants Analyzed 165
Measure Type: Number
Unit of Measure: participants
mean last 2 hour BP < 135/85 110
mean last 2 hour BP < 130/80 85
mean last 2 hour BP < 125/75 63
mean last 2 hour BP < 120/80 49
mean last 2 hour SBP < 135 115
mean last 2 hour SBP < 130 92
mean last 2 hour SBP < 125 76
mean last 2 hour SBP < 120 51
mean last 2 hour DBP < 85 145
mean last 2 hour DBP < 80 125
mean last 2 hour DBP < 75 94
12.Secondary Outcome
Title Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3
Hide Description number 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
Time Frame week 0 - week 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aml + Olm + Hctz
Hide Arm/Group Description:
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Overall Number of Participants Analyzed 201
Measure Type: Number
Unit of Measure: participants
mean BP < 135/85 31
mean BP < 130/80 10
mean BP < 125/75 4
mean BP < 120/80 2
mean SBP < 135 41
mean SBP < 130 17
mean SBP < 125 9
mean SBP < 120 2
mean DBP < 85 99
mean DBP < 80 58
mean DBP < 75 29
13.Secondary Outcome
Title Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6
Hide Description number 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
Time Frame week 0 - week 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aml + Olm + Hctz
Hide Arm/Group Description:
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Overall Number of Participants Analyzed 192
Measure Type: Number
Unit of Measure: participants
mean BP < 135/85 61
mean BP < 130/80 36
mean BP < 125/75 18
mean BP < 120/80 13
mean SBP < 135 73
mean SBP < 130 48
mean SBP < 125 31
mean SBP < 120 14
mean DBP < 85 127
mean DBP < 80 91
mean DBP < 75 48
14.Secondary Outcome
Title Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9
Hide Description number 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
Time Frame week 0 - week 9
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aml + Olm + Hctz
Hide Arm/Group Description:
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Overall Number of Participants Analyzed 184
Measure Type: Number
Unit of Measure: participants
mean BP < 135/85 76
mean BP < 130/80 47
mean BP < 125/75 25
mean BP < 120/80 19
mean SBP < 135 82
mean SBP < 130 61
mean SBP < 125 41
mean SBP < 120 20
mean DBP < 85 132
mean DBP < 80 95
mean DBP < 75 64
15.Secondary Outcome
Title Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12
Hide Description number 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
Time Frame week 0 - week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aml + Olm + Hctz
Hide Arm/Group Description:
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Overall Number of Participants Analyzed 177
Measure Type: Number
Unit of Measure: participants
mean BP < 135/85 86
mean BP < 130/80 61
mean BP < 125/75 33
mean BP < 120/80 28
mean SBP < 135 93
mean SBP < 130 70
mean SBP < 125 46
mean SBP < 120 28
mean DBP < 85 134
mean DBP < 80 105
mean DBP < 75 74
16.Secondary Outcome
Title Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15
Hide Description number 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
Time Frame week 0 - week 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aml + Olm + Hctz
Hide Arm/Group Description:
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Overall Number of Participants Analyzed 172
Measure Type: Number
Unit of Measure: participants
mean BP < 135/85 114
mean BP < 130/80 83
mean BP < 125/75 51
mean BP < 120/80 45
mean SBP < 135 116
mean SBP < 130 95
mean SBP < 125 69
mean SBP < 120 48
mean DBP < 85 153
mean DBP < 80 122
mean DBP < 75 96
17.Secondary Outcome
Title Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18
Hide Description number 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
Time Frame week 0 - week 18
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aml + Olm + Hctz
Hide Arm/Group Description:
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Overall Number of Participants Analyzed 164
Measure Type: Number
Unit of Measure: participants
mean BP < 135/85 117
mean BP < 130/80 87
mean BP < 125/75 56
mean BP < 120/80 49
mean SBP < 135 123
mean SBP < 130 101
mean SBP < 125 74
mean SBP < 120 51
mean DBP < 85 147
mean DBP < 80 128
mean DBP < 75 94
18.Secondary Outcome
Title Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
Hide Description number 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
Time Frame week 0 - week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aml + Olm + Hctz
Hide Arm/Group Description:
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Overall Number of Participants Analyzed 165
Measure Type: Number
Unit of Measure: participants
mean 24-hour SBP reduction =<15 mm Hg 50
mean 24-hour SBP reduction >15 & =<30 mm Hg 91
mean 24-hour SBP reduction >30 & =<45 mm Hg 22
mean 24-hour SBP reduction >45 mm Hg 2
mean 24-hour DBP reduction =<10 mm Hg 72
mean 24-hour DBP reduction >10 & =<15 mm Hg 47
mean 24-hour DBP reduction >15 & =<20 mm Hg 31
mean 24-hour DBP reduction >20 mm Hg 15
19.Secondary Outcome
Title Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
Hide Description number 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
Time Frame week 0 - week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aml + Olm + Hctz
Hide Arm/Group Description:
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Overall Number of Participants Analyzed 165
Measure Type: Number
Unit of Measure: participants
mean daytime SBP reduction =<15 mm Hg 47
mean daytime SBP reduction >15 & =<30 mm Hg 84
mean daytime SBP reduction >30 & =<45 mm Hg 31
mean daytime SBP reduction >45 mm Hg 3
mean daytime DBP reduction =<10 mm Hg 68
mean daytime DBP reduction >10 & =<15 mm Hg 41
mean daytime DBP reduction >15 & =<20 mm Hg 33
mean daytime DBP reduction >20 mm Hg 23
20.Secondary Outcome
Title Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
Hide Description number 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
Time Frame week 0 - week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aml + Olm + Hctz
Hide Arm/Group Description:
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Overall Number of Participants Analyzed 165
Measure Type: Number
Unit of Measure: participants
mean nighttime SBP reduction =<15 mm Hg 60
mean nighttime SBP reduction >15 & =<30 mm Hg 79
mean nighttime SBP reduction >30 & =<45 mm Hg 21
mean nighttime SBP reduction >45 mm Hg 5
mean nighttime DBP reduction =<10 mm Hg 80
mean nighttime SBP reduction >10 & =<15 mm Hg 41
mean nighttime SBP reduction >15 & =<20 mm Hg 21
mean nighttime DBP reduction >20 mm Hg 23
21.Secondary Outcome
Title Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
Hide Description number 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
Time Frame week 0 - week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aml + Olm + Hctz
Hide Arm/Group Description:
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Overall Number of Participants Analyzed 165
Measure Type: Number
Unit of Measure: participants
mean last 6 hour SBP reduction =<15 mm Hg 61
mean last 6 hour SBP reduction >15 & =<30 mm Hg 76
mean last 6 hour SBP reduction >30 & =<45 mm Hg 23
mean last 6 hour SBP reduction >45 mm Hg 5
mean last 6 hour DBP reduction =<10 mm Hg 76
mean last 6 hour DBP reduction >10 & =<15 mm Hg 41
mean last 6 hour DBP reduction >15 & =<20 mm Hg 27
mean last 6 hour DBP reduction >20 mm Hg 21
22.Secondary Outcome
Title Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions
Hide Description number 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
Time Frame week 0 - week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aml + Olm + Hctz
Hide Arm/Group Description:
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Overall Number of Participants Analyzed 165
Measure Type: Number
Unit of Measure: participants
mean last 4 hour SBP reduction =<15 mm Hg 67
mean last 4 hour SBP reduction >15 & =<30 mm Hg 65
mean last 4 hour SBP reduction >30 & =<45 mm Hg 28
mean last 4 hour SBP reduction >45 mm Hg 5
mean last 4 hour DBP reduction =<10 mm Hg 76
mean last 4 hour DBP reduction >10 & =<15 mm Hg 36
mean last 4 hour DBP reduction >15 & =<20 mm Hg 25
mean last 4 hour DBP reduction >20 mm Hg 28
23.Secondary Outcome
Title Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
Hide Description number 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
Time Frame week 0 - week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aml + Olm + Hctz
Hide Arm/Group Description:
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Overall Number of Participants Analyzed 165
Measure Type: Number
Unit of Measure: participants
mean last 2 hour SBP reduction =<15 mm Hg 63
mean last 2 hour SBP reduction >15 & =<30 mm Hg 62
mean last 2 hour SBP reduction >30 & =<45 mm Hg 35
mean last 2 hour SBP reduction >45 mm Hg 5
mean last 2 hour DBP reduction =<10 mm Hg 77
mean last 2 hour DBP reduction >10 & =<15 mm Hg 28
mean last 2 hour DBP reduction >15 & =<20 mm Hg 29
mean last 2 hour DBP reduction >20 mm Hg 31
24.Secondary Outcome
Title Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3
Hide Description number 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
Time Frame week 0 - week 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aml + Olm + Hctz
Hide Arm/Group Description:
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Overall Number of Participants Analyzed 201
Measure Type: Number
Unit of Measure: participants
mean seated SBP reduction =<15 mm Hg 131
mean seated SBP reduction >15 & =<30 mm Hg 62
mean seated SBP reduction >30 & =<45 mm Hg 6
mean seated SBP reduction >45 mm Hg 2
mean seated DBP reduction =<10 mm Hg 163
mean seated DBP reduction >10 & =<15 mm Hg 25
mean seated DBP reduction >15 & =<20 mm Hg 10
mean seated DBP reduction >20 mm Hg 3
25.Secondary Outcome
Title Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6
Hide Description number 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
Time Frame week 0 - week 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aml + Olm + Hctz
Hide Arm/Group Description:
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Overall Number of Participants Analyzed 192
Measure Type: Number
Unit of Measure: participants
mean seated SBP reduction =<15 mm Hg 69
mean seated SBP reduction >15 & =<30 mm Hg 90
mean seated SBP reduction >30 & =<45 mm Hg 31
mean seated SBP reduction >45 mm Hg 2
mean seated DBP reduction =<10 mm Hg 120
mean seated DBP reduction >10 & =<15 mm Hg 33
mean seated DBP reduction >15 & =<20 mm Hg 24
mean seated DBP reduction >20 mm Hg 15
26.Secondary Outcome
Title Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9
Hide Description number 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
Time Frame week 0 - week 9
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aml + Olm + Hctz
Hide Arm/Group Description:
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Overall Number of Participants Analyzed 184
Measure Type: Number
Unit of Measure: participants
mean seated SBP reduction =<15 mm Hg 72
mean seated SBP reduction >15 & =<30 mm Hg 69
mean seated SBP reduction >30 & =<45 mm Hg 34
mean seated SBP reduction >45 mm Hg 9
mean seated DBP reduction =<10 mm Hg 100
mean seated DBP reduction >10 & =<15 mm Hg 43
mean seated DBP reduction >15 & =<20 mm Hg 18
mean seated DBP reduction >20 mm Hg 23
27.Secondary Outcome
Title Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12
Hide Description number 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
Time Frame week 0 - week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aml + Olm + Hctz
Hide Arm/Group Description:
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Overall Number of Participants Analyzed 177
Measure Type: Number
Unit of Measure: participants
mean seated SBP reduction =<15 mm Hg 48
mean seated SBP reduction >15 & =<30 mm Hg 73
mean seated SBP reduction >30 & =<45 mm Hg 45
mean seated SBP reduction >45 mm Hg 11
mean seated DBP reduction =<10 mm Hg 85
mean seated DBP reduction >10 & =<15 mm Hg 42
mean seated DBP reduction >15 & =<20 mm Hg 27
mean seated DBP reduction >20 mm Hg 23
28.Secondary Outcome
Title Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15
Hide Description number 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
Time Frame week 0 - week 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aml + Olm + Hctz
Hide Arm/Group Description:
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Overall Number of Participants Analyzed 172
Measure Type: Number
Unit of Measure: participants
mean seated SBP reduction =<15 mm Hg 31
mean seated SBP reduction >15 & =<30 mm Hg 66
mean seated SBP reduction >30 & =<45 mm Hg 55
mean seated SBP reduction >45 mm Hg 20
mean seated DBP reduction =<10 mm Hg 52
mean seated DBP reduction >10 & =<15 mm Hg 45
mean seated DBP reduction >15 & =<20 mm Hg 32
mean seated DBP reduction >20 mm Hg 43
29.Secondary Outcome
Title Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18
Hide Description number 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
Time Frame week 0 - week 18
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aml + Olm + Hctz
Hide Arm/Group Description:
amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required
Overall Number of Participants Analyzed 164
Measure Type: Number
Unit of Measure: participants
mean seated SBP reduction =<15 mm Hg 22
mean seated SBP reduction >15 & =<30 mm Hg 53
mean seated SBP reduction >30 & =<45 mm Hg 64
mean seated SBP reduction >45 mm Hg 25
mean seated DBP reduction =<10 mm Hg 50
mean seated DBP reduction >10 & =<15 mm Hg 33
mean seated DBP reduction >15 & =<20 mm Hg 29
mean seated DBP reduction >20 mm Hg 52
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ALL - Aml + Olm + Hctz Start - Amlodipine 5 mg Titration 1 - Amlodipine 5 mg / Olmesartan 20 mg Titration 2 - Amlodipine 5 mg / Olmesartan 40 mg Titration 3 - Amlodipine 10 mg / Olmesartan 40 mg Titration 4 Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 12.5 mg Titration 5 - Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 25 mg
Hide Arm/Group Description Summary of ALL participants receiving amlodipine + olmesartan medoxomil, if required, + hydrochlorothiazide, if required All participants started trial on Amlodipine 5 mg. Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen. Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen. Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen. Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen. Participants not meeting blood pressure (BP) goals on previous regimen were titrated to this regimen.
All-Cause Mortality
ALL - Aml + Olm + Hctz Start - Amlodipine 5 mg Titration 1 - Amlodipine 5 mg / Olmesartan 20 mg Titration 2 - Amlodipine 5 mg / Olmesartan 40 mg Titration 3 - Amlodipine 10 mg / Olmesartan 40 mg Titration 4 Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 12.5 mg Titration 5 - Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 25 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ALL - Aml + Olm + Hctz Start - Amlodipine 5 mg Titration 1 - Amlodipine 5 mg / Olmesartan 20 mg Titration 2 - Amlodipine 5 mg / Olmesartan 40 mg Titration 3 - Amlodipine 10 mg / Olmesartan 40 mg Titration 4 Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 12.5 mg Titration 5 - Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 25 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/207 (1.93%)      0/207 (0.00%)      0/195 (0.00%)      1/177 (0.56%)      0/167 (0.00%)      1/146 (0.68%)      2/101 (1.98%)    
Infections and infestations               
pneumonia  1  1/207 (0.48%)  1 0/207 (0.00%)  0 0/195 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 0/146 (0.00%)  0 1/101 (0.99%)  1
Metabolism and nutrition disorders               
hyperkalaemia  1  1/207 (0.48%)  1 0/207 (0.00%)  0 0/195 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 1/146 (0.68%)  1 0/101 (0.00%)  0
Nervous system disorders               
presyncope  2  1/207 (0.48%)  1 0/207 (0.00%)  0 0/195 (0.00%)  0 0/177 (0.00%)  0 0/167 (0.00%)  0 1/146 (0.68%)  1 0/101 (0.00%)  0
Respiratory, thoracic and mediastinal disorders               
chronic obstructive pulmonary disease  2  1/207 (0.48%)  1 0/207 (0.00%)  0 0/195 (0.00%)  0 1/177 (0.56%)  1 0/167 (0.00%)  0 0/146 (0.00%)  0 1/101 (0.99%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
2
Term from vocabulary, MedDRA (11.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
ALL - Aml + Olm + Hctz Start - Amlodipine 5 mg Titration 1 - Amlodipine 5 mg / Olmesartan 20 mg Titration 2 - Amlodipine 5 mg / Olmesartan 40 mg Titration 3 - Amlodipine 10 mg / Olmesartan 40 mg Titration 4 Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 12.5 mg Titration 5 - Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 25 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   80/207 (38.65%)      16/207 (7.73%)      15/195 (7.69%)      10/177 (5.65%)      21/167 (12.57%)      14/146 (9.59%)      4/101 (3.96%)    
Blood and lymphatic system disorders               
anaemia  1  7/207 (3.38%)  7 0/207 (0.00%)  0 0/195 (0.00%)  0 0/177 (0.00%)  0 4/167 (2.40%)  4 1/146 (0.68%)  1 2/101 (1.98%)  2
General disorders               
oedema peripheral  1  20/207 (9.66%)  20 7/207 (3.38%)  7 3/195 (1.54%)  3 2/177 (1.13%)  2 7/167 (4.19%)  7 1/146 (0.68%)  1 0/101 (0.00%)  0
Infections and infestations               
upper respiratory tract infection  1  11/207 (5.31%)  11 0/207 (0.00%)  0 2/195 (1.03%)  2 3/177 (1.69%)  3 3/167 (1.80%)  3 3/146 (2.05%)  3 0/101 (0.00%)  0
bronchitis  1  5/207 (2.42%)  5 1/207 (0.48%)  1 2/195 (1.03%)  2 0/177 (0.00%)  0 1/167 (0.60%)  1 1/146 (0.68%)  1 0/101 (0.00%)  0
Musculoskeletal and connective tissue disorders               
pain in extremity  1  5/207 (2.42%)  5 1/207 (0.48%)  1 2/195 (1.03%)  2 1/177 (0.56%)  1 0/167 (0.00%)  0 1/146 (0.68%)  1 0/101 (0.00%)  0
arthralgia  1  5/207 (2.42%)  5 1/207 (0.48%)  1 3/195 (1.54%)  3 0/177 (0.00%)  0 1/167 (0.60%)  1 0/146 (0.00%)  0 0/101 (0.00%)  0
Nervous system disorders               
dizziness  1  12/207 (5.80%)  12 3/207 (1.45%)  3 1/195 (0.51%)  1 2/177 (1.13%)  2 1/167 (0.60%)  1 5/146 (3.42%)  5 0/101 (0.00%)  0
headache  1  6/207 (2.90%)  6 3/207 (1.45%)  3 0/195 (0.00%)  0 0/177 (0.00%)  0 2/167 (1.20%)  2 0/146 (0.00%)  0 1/101 (0.99%)  1
Respiratory, thoracic and mediastinal disorders               
cough  1  5/207 (2.42%)  5 0/207 (0.00%)  0 1/195 (0.51%)  1 2/177 (1.13%)  2 2/167 (1.20%)  2 0/146 (0.00%)  0 0/101 (0.00%)  0
Vascular disorders               
hypotension  1  4/207 (1.93%)  4 0/207 (0.00%)  0 1/195 (0.51%)  1 0/177 (0.00%)  0 0/167 (0.00%)  0 2/146 (1.37%)  2 1/101 (0.99%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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."
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: James McCarthy
Organization: Daiichi Sankyo
Phone: 732-590-3430
EMail: jmccarthy@dsi.com
Layout table for additonal information
Responsible Party: Director, Medical Research, Hypertension, Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT00654745     History of Changes
Other Study ID Numbers: CS-8663-403
First Submitted: April 4, 2008
First Posted: April 9, 2008
Results First Submitted: April 21, 2010
Results First Posted: July 2, 2010
Last Update Posted: July 13, 2010