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
|Condition or disease||Intervention/treatment||Phase|
|Essential Hypertension||Drug: olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ) tablets Drug: olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mg||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1011 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Efficacy and Safety of Olmesartan Medoxomil/Hydrochlorothiazide Combination 20/25 mg Versus 40/25 mg in Moderately to Severely Hypertensive Patients Not Adequately Controlled by Olmesartan Medoxomil 40 mg Monotherapy|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||October 2008|
olmesartan medoximil (OM)/ hydrochlorothiazide (HCTZ) 40/25 mg + OM/HCTZ 20/25 mg matching placebo
Drug: olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ) tablets
olmesartan medoxomil (OM)+ hydrochlorothiazide (HCTZ)tablets 40mg/25mg + 20mg/25mg matching placebo tablets once daily for 8 weeks
olmesartan medoximil (OM)/ hydrochlorothiazide (HCTZ)20/25 mg + OM/HCTZ 40/25 matching placebo
Drug: olmesartan medoxomil (OM)/ hydrochlorothiazide (HCTZ) 20mg/25mg
olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ)20mg/25mg tablet + 40mg/25mg matching placebo tablet once a day for 8 weeks
- Change in Mean Trough Sitting Diastolic Blood Pressure [ Time Frame: 8 weeks ]
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).
- Change in Mean Trough Sitting Diastolic Blood Pressure From Week 8(Baseline) to Week 12 [ Time Frame: 4 weeks ]Change = Week 12 - Week 8 (baseline).
- Change in Sitting Systolic Blood Pressure 4 Weeks and 8 Weeks After Baseline. [ Time Frame: 8 weeks ]4 weeks Change = Week 12 - Week 8 (baseline). 8 weeks Change = Week 16 - Week 8 (baseline).
- Change in Daytime, Nighttime and 24-hour Blood Pressure Evaluated by Ambulatory Blood Pressure Monitoring 8 Weeks After Baseline. [ Time Frame: 8 weeks ]Change = Week 16 - Week 8 (baseline).
- Number of Participants Achieving Blood Pressure Goal. [ Time Frame: 8 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00430950
|Alphen aan den Rijn, Netherlands|
|Amsterdam Zuidoost, Netherlands|
|De Bilt, Netherlands|
|Den Bosch, Netherlands|
|Den Haag, Netherlands|
|Nove Zamky, Slovakia|
|Study Chair:||Professor Lars Christian Rump, M.D.||University of Ruhr-Bochum|