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Trial record 50 of 134 for:    OLMESARTAN

Use of the Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension

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: NCT00430508
Recruitment Status : Completed
First Posted : February 2, 2007
Results First Posted : June 17, 2009
Last Update Posted : January 9, 2019
Sponsor:
Collaborator:
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Information provided by:
Daiichi Sankyo, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Essential Hypertension
Interventions Drug: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placebo
Drug: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets
Drug: olmesartan medoxomil/hydrochlorothiazide tablets
Enrollment 972
Recruitment Details

78 investigative sites screened patients in Europe (19 in Czech Republic, 11 in Germany, 8 in Bulgaria, 5 in Spain, 20 in Ukraine, 1 in France and 14 in Poland).

Sites were either hospitals or general practitioners. First patient in: 17 January 2007 Last patient out: 30 March 2008

Pre-assignment Details Trial is 2-week taper-off phase and 2 treatment periods. Period I-8-week open-label, OM 40mg. End of Period I, only non-responders randomised to Period II. Blood Pressure controlled patients discontinued. Period II-8-week double-blind four randomized treatment arms. Participant flow is Period II. 972 completed period I, 971 started period II.
Arm/Group Title OM/HCTZ 40/25mg + 20/12.5 Matching Placebo OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo OM/HCTZ 20/12.5mg + 40/0 Matching Placebo OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
Hide Arm/Group Description olmesartan medoxomil/Hydrochlorothizaide 40/25mg tablets, once daily for 8 weeks olmesartan medoxomil/Hydrochlorothizaide 40/12.5mg tablets, once daily for 8 weeks olmesartan medoxomil/Hydrochlorothizaide 20/12.5mg tablets, once daily for 8 weeks olmesartan medoxomil/Hydrochlorothizaide 40/0mg tablets, once daily for 8 weeks
Period Title: Overall Study
Started 140 278 279 274
Completed 137 272 266 269
Not Completed 3 6 13 5
Reason Not Completed
Adverse Event             2             3             5             3
Withdrawal by Subject             0             1             1             1
responder at visit 4             0             0             2             0
conmed-BP-pulse-ABPM withdrawal criteria             0             1             2             1
not specified             1             1             3             0
Arm/Group Title OM/HCTZ 40/25mg + 20/12.5 Matching Placebo OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo OM/HCTZ 20/12.5mg + 40/0 Matching Placebo OM/HCTZ 40/0mg + 20/12.5 Matching Placebo Total
Hide Arm/Group Description olmesartan medoxomil/Hydrochlorothizaide 40/25mg tablets, once daily for 8 weeks olmesartan medoxomil/Hydrochlorothizaide 40/12.5mg tablets, once daily for 8 weeks olmesartan medoxomil/Hydrochlorothizaide 20/12.5mg tablets, once daily for 8 weeks olmesartan medoxomil/Hydrochlorothizaide 40/0mg tablets, once daily for 8 weeks Total of all reporting groups
Overall Number of Baseline Participants 140 278 279 274 971
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 140 participants 278 participants 279 participants 274 participants 971 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
122
  87.1%
240
  86.3%
233
  83.5%
238
  86.9%
833
  85.8%
>=65 years
18
  12.9%
38
  13.7%
46
  16.5%
36
  13.1%
138
  14.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 140 participants 278 participants 279 participants 274 participants 971 participants
55.2  (8.17) 53.7  (9.77) 55.2  (9.47) 54.1  (8.92) 54.5  (9.24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 140 participants 278 participants 279 participants 274 participants 971 participants
Female
52
  37.1%
105
  37.8%
100
  35.8%
115
  42.0%
372
  38.3%
Male
88
  62.9%
173
  62.2%
179
  64.2%
159
  58.0%
599
  61.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 140 participants 278 participants 279 participants 274 participants 971 participants
European 140 278 278 274 970
Other 0 0 1 0 1
1.Primary Outcome
Title Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 16
Hide Description Change = Week 16 - Week 8 (baseline).
Time Frame 8 weeks, change = week 16 - week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set-Last Observation Carried Forward.
Arm/Group Title OM/HCTZ 40/25mg + 20/12.5 Matching Placebo OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo OM/HCTZ 20/12.5mg + 40/0 Matching Placebo OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
Hide Arm/Group Description:
olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
Overall Number of Participants Analyzed 140 277 279 274
Mean (Standard Deviation)
Unit of Measure: mm Hg
-11.16  (8.796) -9.13  (8.622) -8.10  (7.968) -5.66  (8.546)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OM/HCTZ 40/25mg + 20/12.5 Matching Placebo, OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
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 ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -5.3
Confidence Interval 95%
-6.97 to -3.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo, OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
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 ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.4
Confidence Interval 95%
-4.79 to -2.03
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo, OM/HCTZ 20/12.5mg + 40/0 Matching Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1788
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.9
Confidence Interval 95%
-2.32 to 0.43
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12.
Hide Description Change = Week 12 - Week 8 (baseline).
Time Frame 4 weeks, change = week 12 - week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set-Last Observation Carried Forward
Arm/Group Title OM/HCTZ 40/25mg + 20/12.5 Matching Placebo OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo OM/HCTZ 20/12.5mg + 40/0 Matching Placebo OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
Hide Arm/Group Description:
olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
Overall Number of Participants Analyzed 140 277 279 274
Mean (Standard Deviation)
Unit of Measure: mm Hg
-8.74  (7.879) -7.72  (7.606) -6.66  (7.090) -4.47  (7.197)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OM/HCTZ 40/25mg + 20/12.5 Matching Placebo, OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
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 ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.1
Confidence Interval 95%
-5.54 to -2.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo, OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
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 ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.2
Confidence Interval 95%
-4.39 to -1.98
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo, OM/HCTZ 20/12.5mg + 40/0 Matching Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1081
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.0
Confidence Interval 95%
-2.19 to 0.22
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 16.
Hide Description Change = Week 16 - Week 8 (baseline).
Time Frame 8 weeks, change = week 16 - week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set-Last Observation Carried Forward.
Arm/Group Title OM/HCTZ 40/25mg + 20/12.5 Matching Placebo OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo OM/HCTZ 20/12.5mg + 40/0 Matching Placebo OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
Hide Arm/Group Description:
olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
Overall Number of Participants Analyzed 140 277 279 274
Mean (Standard Deviation)
Unit of Measure: mm Hg
-16.17  (13.444) -13.52  (14.533) -11.46  (13.673) -8.85  (13.537)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OM/HCTZ 40/25mg + 20/12.5 Matching Placebo, OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
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 ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -7.4
Confidence Interval 95%
-10.13 to -4.66
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo, OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
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 ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -5.2
Confidence Interval 95%
-7.4 to -2.91
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo, OM/HCTZ 20/12.5mg + 40/0 Matching Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0255
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.6
Confidence Interval 95%
-4.79 to -0.31
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in Mean Trough Sitting Systolic Blood Pressure From Week 8(Baseline) to Week 12.
Hide Description Change = Week 12 - Week 8 (baseline).
Time Frame 4 weeks, change = week 12 - week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set-Last Observation Carried Forward
Arm/Group Title OM/HCTZ 40/25mg + 20/12.5 Matching Placebo OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo OM/HCTZ 20/12.5mg + 40/0 Matching Placebo OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
Hide Arm/Group Description:
olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
Overall Number of Participants Analyzed 140 277 279 274
Mean (Standard Deviation)
Unit of Measure: mm Hg
-13.16  (13.337) -10.90  (12.297) -9.65  (11.743) -6.60  (10.932)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OM/HCTZ 40/25mg + 20/12.5 Matching Placebo, OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
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 ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -6.6
Confidence Interval 95%
-9.00 to -4.26
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo, OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
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 ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.8
Confidence Interval 95%
-6.70 to -2.81
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo, OM/HCTZ 20/12.5mg + 40/0 Matching Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0812
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.7
Confidence Interval 95%
-3.66 to 0.21
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Patients Achieving Target Blood Pressure at Week 16
Hide Description Target Blood Pressure is diastolic blood pressure (dBP) < 90 mmHg and systolic blood pressure (sBP) < 140 mmHg for non-diabetics, and dBP < 80 mmHg and sBP < 130 mmHg for diabetics
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set-Last Observation Carried Forward
Arm/Group Title OM/HCTZ 40/25mg + 20/12.5 Matching Placebo OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo OM/HCTZ 20/12.5mg + 40/0 Matching Placebo OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
Hide Arm/Group Description:
olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
Overall Number of Participants Analyzed 140 277 279 274
Measure Type: Number
Unit of Measure: participants
59 110 88 68
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OM/HCTZ 40/25mg + 20/12.5 Matching Placebo, OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.67
Confidence Interval 95%
1.69 to 4.21
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo, OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.20
Confidence Interval 95%
1.50 to 3.24
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo, OM/HCTZ 20/12.5mg + 40/0 Matching Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.55
Confidence Interval 95%
1.07 to 2.25
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change in Mean 24-hour Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.
Hide Description Change = Week 16 - Week 8 (baseline).
Time Frame 8 weeks, change = week 16 - week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set-Observed Cases
Arm/Group Title OM/HCTZ 40/25mg + 20/12.5 Matching Placebo OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo OM/HCTZ 20/12.5mg + 40/0 Matching Placebo OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
Hide Arm/Group Description:
olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
Overall Number of Participants Analyzed 120 250 241 249
Mean (Standard Deviation)
Unit of Measure: mm Hg
-7.2  (7.62) -5.3  (8.60) -4.1  (9.07) -2.0  (7.64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OM/HCTZ 40/25mg + 20/12.5 Matching Placebo, OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
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 ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -5.1
Confidence Interval 95%
-6.78 to -3.36
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo, OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
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 ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.2
Confidence Interval 95%
-4.54 to -1.78
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo, OM/HCTZ 20/12.5mg + 40/0 Matching Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1452
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.0
Confidence Interval 95%
-2.43 to 0.36
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change in Mean Daytime Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.
Hide Description Change = Week 16 - Week 8 (baseline).
Time Frame 8 weeks, change = week 16 - week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set-Observed Cases
Arm/Group Title OM/HCTZ 40/25mg + 20/12.5 Matching Placebo OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo OM/HCTZ 20/12.5mg + 40/0 Matching Placebo OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
Hide Arm/Group Description:
olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
Overall Number of Participants Analyzed 120 250 241 249
Mean (Standard Deviation)
Unit of Measure: mm Hg
-7.0  (8.06) -5.5  (9.10) -4.0  (9.34) -1.8  (8.39)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OM/HCTZ 40/25mg + 20/12.5 Matching Placebo, OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
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 ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -5.0
Confidence Interval 95%
-6.79 to -3.17
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo, OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
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 ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.3
Confidence Interval 95%
-4.79 to -1.87
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo, OM/HCTZ 20/12.5mg + 40/0 Matching Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1629
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.0
Confidence Interval 95%
-2.52 to 0.42
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change in Mean Night-time Ambulatory Blood Pressure Monitoring Diastolic Blood Pressure From Week 8(Baseline) to Week 16.
Hide Description Change = Week 16 - Week 8 (baseline).
Time Frame 8 weeks, change = week 16 - week 8
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Full Analysis Set-Observed Cases
Arm/Group Title OM/HCTZ 40/25mg + 20/12.5 Matching Placebo OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo OM/HCTZ 20/12.5mg + 40/0 Matching Placebo OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
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olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
Overall Number of Participants Analyzed 120 250 241 249
Mean (Standard Deviation)
Unit of Measure: mm Hg
-7.9  (9.51) -4.5  (9.90) -4.2  (10.61) -2.3  (8.47)
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Statistical Analysis Overview Comparison Group Selection OM/HCTZ 40/25mg + 20/12.5 Matching Placebo, OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
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 ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -5.5
Confidence Interval 95%
-7.40 to -3.62
Estimation Comments [Not Specified]
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Statistical Analysis Overview Comparison Group Selection OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo, OM/HCTZ 40/0mg + 20/12.5 Matching Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0009
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.6
Confidence Interval 95%
-4.12 to -1.07
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo, OM/HCTZ 20/12.5mg + 40/0 Matching Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1985
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.0
Confidence Interval 95%
-2.55 to 0.53
Estimation Comments [Not Specified]
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.
Results of Study shall not be published without prior express written consent and approval of Sponsor. If Contractor wishes to use data generated at Sites by Investigator, such data includes but not limited to data used in collection of metrics, copy of any intended publication, details of use must be sent in writing to Quintiles and Sponsor for review. Sponsor has right to change proposed publication and/or prohibit publication and Contractor must comply with requirements of Sponsor
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: James McCarthy / Director Regulatory Operations
Organization: Daiichi Sankyo
Phone: 732-590-3430
EMail: jmccarthy@dsus.com
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Responsible Party: Bettina Ammentorp, Daichi Sankyo Europe, GmbH
ClinicalTrials.gov Identifier: NCT00430508     History of Changes
Other Study ID Numbers: CS866CM-B-E301
First Submitted: February 1, 2007
First Posted: February 2, 2007
Results First Submitted: February 9, 2009
Results First Posted: June 17, 2009
Last Update Posted: January 9, 2019