Olmesartan as an add-on to Amlodipine in Hypertension

Phase 3CompletedNCT00220233

Sankyo Pharma Gmbh632 enrolled

Overview

This study is to test the efficacy and safety of the combination of olmesartan and amlodipine in hypertensive patients whose blood pressure is not adequately controlled with amlodipine alone

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

632

Conditions

Essential Hypertension

Interventions

olmesartan medoxomilDRUG

amlodipineDRUG

hydrochlorothiazideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Without antihypertensive pre-treatment mean seated BP greater than 160/100 mmHg * Pre-treatment with amlodipine 5 or 10 mg: mean seated BP greater than or equal to 140/90 mmHg Exclusion Criteria: * Secondary hypertension * Any serious disorder which may limit the ability to evaluate the efficacy or safety of the test drugs

Locations (5)

Unnamed facility

Leipzig, Germany

Unnamed facility

Sinsheim, Germany

Unnamed facility

Tann, Germany

Unnamed facility

Weinheim, Germany

Unnamed facility

Wiesbaden, Germany

Outcomes

Primary Outcomes

Mean change in trough seated diastolic blood pressure

Secondary Outcomes

Mean change in trough seated systolic BP

Mean change in daytime, nighttime and 24 hour ambulatory blood pressure

Percent of patients achieving target blood pressure goal

Safety and tolerability

Data from ClinicalTrials.gov

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