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Trial record 48 of 443 for:    Hydrochlorothiazide

Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension

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ClinicalTrials.gov Identifier: NCT00430950
Recruitment Status : Completed
First Posted : February 2, 2007
Results First Posted : April 20, 2009
Last Update Posted : January 10, 2019
Sponsor:
Collaborator:
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Information provided by (Responsible Party):
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
Drug: olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mg
Enrollment 1011
Recruitment Details

92 principal investigators screened patients at clinical sites in Europe (8 in Belgium, 17 in Germany, 12 in the Netherlands, 17 in Poland, 19 in Russia, 10 in Slovakia, and 9 in the Ukraine).Sites were either hospitals or general practitioners.

First patient in: 05 December 2006 Last patient out: 07 May 2008

Pre-assignment Details Trial is 2 week taper-off phase and 2 treatment periods. Period I - 8-week open-label OM 40mg. Only non-responders eligible to randomise into Period II. Period II - 8-week double-blind patients assigned into one of two arms. Results provided for Period II only.
Arm/Group Title OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo
Hide Arm/Group Description Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
Period Title: Overall Study
Started 502 508
Completed 489 495
Not Completed 13 13
Reason Not Completed
Adverse Event             7             6
Withdrawal by Subject             1             0
concomitant medication,etc.             5             7
Arm/Group Title OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo Total
Hide Arm/Group Description Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo Total of all reporting groups
Overall Number of Baseline Participants 502 508 1010
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 502 participants 508 participants 1010 participants
<=18 years 0 0 0
Between 18 and 65 years 404 422 826
>=65 years 93 75 168
>= 75 years 5 11 16
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 502 participants 508 participants 1010 participants
54.7  (9.67) 54.4  (9.77) 54.6  (9.72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 502 participants 508 participants 1010 participants
Female
194
  38.6%
201
  39.6%
395
  39.1%
Male
308
  61.4%
307
  60.4%
615
  60.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
European Number Analyzed 502 participants 508 participants 1010 participants
502 508 1010
1.Primary Outcome
Title Change in Mean Trough Sitting Diastolic Blood Pressure
Hide Description

Change in mean trough sitting diastolic Blood Pressure between OM/HCTZ 20/25 mg vs. 40/25 mg, in those patients inadequately controlled on OM 40 mg monotherapy, after eight weeks of double blind treatment, as compared to baseline.

Change = Week 16 - Week 8 (baseline).

Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The main analysis will be performed on the full analysis set last observation carried forward (LOCF). Pooling will be applied for small centres.
Arm/Group Title OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo
Hide Arm/Group Description:
Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
Overall Number of Participants Analyzed 502 508
Mean (Standard Deviation)
Unit of Measure: mm Hg
-11.16  (8.851) -10.45  (7.928)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo, OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo
Comments

The ANCOVA model included treatment as main effect and baseline mean trough sitting dBP as covariate.

Significance level alpha = 5%. Power = 80%.

The following statistical superiority hypothesis was tested:

Superiority of OM/HCTZ combination therapy 40/25 mg over OM/HCTZ 20/25 mg

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2648
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.5
Confidence Interval 95%
-1.51 to 0.42
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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo
Hide Arm/Group Description:
Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
Overall Number of Participants Analyzed 502 508
Mean (Standard Deviation)
Unit of Measure: mm Hg
-9.32  (7.820) -8.83  (7.584)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo, OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4246
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.4
Confidence Interval 95%
-1.26 to 0.53
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline.
Hide Description 4 weeks Change = Week 12 - Week 8 (baseline). 8 weeks Change = Week 16 - Week 8 (baseline).
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo
Hide Arm/Group Description:
Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
Overall Number of Participants Analyzed 502 508
Mean (Standard Deviation)
Unit of Measure: mm Hg
Change from baseline (Week 8) to Week 16 in sBP -17.41  (13.930) -17.09  (13.126)
Change from baseline (Week 8) to Week 12 in sBP -14.07  (12.654) -13.80  (12.519)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo, OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7019
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.3
Confidence Interval 95%
-1.84 to 1.24
Estimation Comments refers to 8 week change; from week 8 to week 16
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo, OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7328
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.3
Confidence Interval 95%
-1.71 to 1.21
Estimation Comments refers to 4 week change; from week 8 to week 12
4.Secondary Outcome
Title Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline.
Hide Description Change = Week 16 - Week 8 (baseline).
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Exploratory analysis: ANCOVA was used to compare the differences in change from baseline (Visit 4, Week 8) to Week 16 (Visit 6) in daytime, nighttime and 24-hr ABPM dBP and sBP.
Arm/Group Title OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo
Hide Arm/Group Description:
Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
Overall Number of Participants Analyzed 442 442
Mean (Standard Deviation)
Unit of Measure: mm Hg
Change from Week 8 to Wk 16 in mean 24-hr ABPM dBP -9.2  (8.69) -7.6  (8.03)
Change from Week 8 to wk16 in daytime ABPM dBP -9.3  (9.18) -7.7  (8.48)
Change from Week 8 to wk16 in nighttime ABPM dBP -8.6  (9.52) -7.0  (9.49)
Change from Week 8 to wk16 in mean 24-hr ABPM sBP -14.7  (13.75) -12.0  (11.81)
Change from Week 8 to wk16 in daytime ABPM sBP -15.0  (14.36) -12.3  (12.45)
Change from Week 8 to wk16 in nighttime ABPM sBP -13.4  (14.59) -10.7  (13.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo, OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0016
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.6
Confidence Interval 95%
-2.58 to -0.60
Estimation Comments 24 hour Ambulatory Blood Pressure Monitoring (ABPM) diastolic blood pressure (dBP)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo, OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0031
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.6
Confidence Interval 95%
-2.61 to -0.53
Estimation Comments daytime Ambulatory Blood Pressure Monitoring (ABPM) diastolic blood pressure (dBP)
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo, OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0073
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.5
Confidence Interval 95%
-2.58 to -0.40
Estimation Comments night-time Ambulatory Blood Pressure Monitoring (ABPM) diastolic blood pressure (dBP)
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo, OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0021
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.3
Confidence Interval 95%
-3.71 to -0.82
Estimation Comments 24 hour Ambulatory Blood Pressure Monitoring (ABPM) systolic blood pressure (sBP)
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo, OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0031
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.3
Confidence Interval 95%
-3.76 to -0.76
Estimation Comments daytime Ambulatory Blood Pressure Monitoring (ABPM) systolic blood pressure (sBP)
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo, OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0104
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.0
Confidence Interval 95%
-3.61 to -0.48
Estimation Comments night-time Ambulatory Blood Pressure Monitoring (ABPM) systolic blood pressure (sBP)
5.Secondary Outcome
Title Number of Participants Achieving Blood Pressure Goal.
Hide Description [Not Specified]
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo
Hide Arm/Group Description:
Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
Overall Number of Participants Analyzed 502 508
Measure Type: Number
Unit of Measure: participants
260 255
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo, OM/HCTZ 20/25 mg + 40/25 mg 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 1.09
Confidence Interval 95%
0.85 to 1.40
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: Global Clinical Leader
Organization: Daiichi Sankyo
Phone: 908-992-6400
EMail: DataSharing@dsi.com
Layout table for additonal information
Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT00430950     History of Changes
Other Study ID Numbers: CS866CM-B-E302
First Submitted: February 1, 2007
First Posted: February 2, 2007
Results First Submitted: February 9, 2009
Results First Posted: April 20, 2009
Last Update Posted: January 10, 2019