Amlodipine as Add-on to Olmesartan in Hypertension
This study has been completed.
Sankyo Pharma Gmbh
Information provided by:
Daiichi Sankyo Inc.
First received: September 16, 2005
Last updated: October 10, 2007
Last verified: October 2007
Test the efficacy and safety of the combination of olmesartan and amlodipine in hypertensive patients whose blood pressure is not adequately controlled with olmesartan alone.
Drug: olmesartan medoxomil
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of Amlodipine Used as Add-on Therapy in Moderately to Severely Hypertensive Patients Not Adequately Controlled by Olmesartan Medoxomil 20 mg Monotherapy|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Daiichi Sankyo Inc.:
Primary Outcome Measures:
- Mean change in trough sitting diastolic blood pressure (dBP) assessed by conventional BP measurements after 8 weeks of double-blind treatment.
Secondary Outcome Measures:
- Mean change in trough sitting sBP and mean BP daytime, nighttime and 24h ABPM after 8 weeks of double-blind treatment.
- Responder rate, defined as number (%) of patients achieving BP goals during 8 weeks of double-blind treatment.
- Safety and tolerability
|Study Start Date:||April 2005|
|Study Completion Date:||April 2007|
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