NCT00923091

Parallel-Group Comparison of Olmesartan (OLM), Amlodipine (AML) and Hydrochlorothiazid (HCTZ) in Hypertension

Randomised, Double-Blind, Parallel-Group Study Evaluating Efficacy and Safety of Co-Administration of Triple Combinations of Olmesartan Medoxomil, Amlodipine Besylate, and Hydrochlorothiazide Compared With Corresponding Olmesartan - Amlodipine Combination in Subjects With Hypertension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,689 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to determine the change in blood pressure from the administration of Olmesartan/Amlodipine/Hydrochlorothiazide triple combinations compared to dual combinations with Olmesartan/Amlodipine.

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
DRUG	olmesartan medoxomil + amlodipine + hydroclororthiazide + placebo	One olmesartan medoxomil 20 mg + amlodipine 5 mg combination oral tablet taken once per day. One hydrochlorothiazide 12.5 mg tablet + one hydrochlorothiazide 12.5 mg placebo tablet taken once per day.
DRUG	Olmesartan medoxomil + amlodipine + hydrochlorothiazide + placebo	One olmesartan medoxomil 40 mg + amlodipine 5 mg combination oral tablet taken once per day. One hydrochlorothiazide 12.5 mg tablet + one hydrochlorothiazide 12.5 mg placebo tablet taken once per day.
DRUG	olmesartan medoxomil + amlodipine + hydroclororthiazide	One olmesartan medoxomil 40 mg + amlodipine 5 mg combination oral tablet taken once per day. Two hydrochlorothiazide 12.5 mg tablets taken once per day.
DRUG	olmesartan medoxomil + amlodipine + hydroclororthiazide	One olmesartan medoxomil 40 mg + amlodipine 10 mg combination oral tablet taken once per day. One hydrochlorothiazide 12.5 mg tablet + one hydrochlorothiazide 12.5 mg placebo tablet taken once per day.
DRUG	olmesartan medoxomil + amlodipine + hydroclororthiazide	One olmesartan medoxomil 40 mg + amlodipine 10 mg combination oral tablet taken once per day. Two hydrochlorothiazide 12.5 mg tablets taken once per day.
DRUG	olmesartan medoxomil + amlodipine	One olmesartan medoxomil 20 mg + amlodipine 5 mg combination oral tablet taken once per day
DRUG	olmesartan medoxomil + amlodipine	One olmesartan medoxomil 40 mg + amlodipine 5 mg combination oral tablet taken once per day.
DRUG	olmesartan medoxomil + amlodipine	One olmesartan medoxomil 40 mg + amlodipine 10 mg combination oral tablet taken once per day.

Timeline

• Start date: 2009-06-01
• Primary completion: 2011-01-01
• Completion: 2011-03-01
• First posted: 2009-06-18
• Last updated: 2019-01-10
• Results posted: 2012-04-06

Locations

133 sites across 15 countries: Belgium, Bulgaria, Czechia, Denmark, Germany, Hungary, Italy, Latvia, Netherlands, Poland, Romania, Russia, Slovakia, Spain, Ukraine