Efficacy and Safety of Olmesartan Medoxomil in Stage 1 and 2 Essential Hypertension (Benibest)
This study has been completed.
Daiichi Sankyo, Inc.
First Posted: April 30, 2009
Last Update Posted: July 29, 2009
Information provided by:
Daiichi Sankyo, Inc.
In patients naive to treatment or after a 2-week washout period for patients whose treatment was ineffective, the use of olmesartan was assessed in a 4-phase treatment scheme: monotherapy, addition of hydrochlorothiazide (2 phases), addition of amlodipine.
|Essential Hypertension||Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||National, Multicenter, Open-Label and Prospective Study Assessment of Efficacy and Safety in Stage 1 and 2 Essential Hypertension With Olmesartan Medoxomil Based Treatment Algorithm From Monotherapy to Association With Hydrochlorothiazide and Amlodipine Besylate|
Resource links provided by NLM:
Drug Information available for: Hydrochlorothiazide Amlodipine Amlodipine besylate Olmesartan Olmesartan medoxomilU.S. FDA Resources
Further study details as provided by Daiichi Sankyo, Inc.:
Primary Outcome Measures:
- Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 (Olmesartan 20 mg Monotherapy) [ Time Frame: 4 - 9 wks of olmesartan monotherapy ]
- Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in First Titrated Group (Olmesartan 20 mg + 12.5 mg Hydrochlorothiazide) [ Time Frame: 4 to 9 weeks on combination therapy ]
- Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Second Titrated Group (Olmesartan 40 mg + 25 mg Hydrochlorothiazide) [ Time Frame: 4 to 9 weeks ]
- Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Third Titrated Group (Olmesartan + Hydrochorothiazide + Amlodipine) [ Time Frame: 4 - 9 weeks ]
|Study Start Date:||August 2006|
|Study Completion Date:||August 2007|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary
olmesartan medoxomil tablets,or olmesartan medoxomil/hydrochlorothiazide tablets, if necessary + amlodipine tablets, if necessary. All interventions are once-daily for 4 to 9 weeks
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