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

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

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.

Sponsors & Collaborators

• Daiichi Sankyo

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-06-30

Primary Completion

2011-01-31

Completion

2011-03-31

Countries

• Belgium
• Bulgaria
• Czechia
• Denmark
• Germany
• Hungary
• Italy
• Latvia
• Netherlands
• Poland
• Romania
• Russia
• Slovakia
• Spain
• Ukraine

Study Locations