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Efficacy and Safety of Valsartan and Amlodipine in Patients With Essential Hypertension

NCT00425373 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1474

Last updated 2011-04-29

Study results available
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Summary

The purpose of this study is to evaluate the safety and efficacy of fixed combination of valsartan (40 mg and 80 mg) and amlodipine (2.5 mg and 5 mg), valsartan and amlodipine alone, and placebo in reducing blood pressure. The study will investigate the dose response relationship for the combinations, monotherapies, and placebo.

Conditions

  • Essential Hypertension

Interventions

DRUG

Valsartan + amlodipine 40/2.5 mg

Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily

DRUG

Valsartan + amlodipine 40/5 mg

Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily

DRUG

Valsartan + amlodipine 80/2.5 mg

Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily

DRUG

Valsartan + amlodipine 80/5 mg

Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily

DRUG

Valsartan 40 mg

Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily

DRUG

Valsartan 80 mg

Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily

DRUG

Amlodipine 2.5 mg

Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily

DRUG

Amlodipine 5 mg

Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily

DRUG

Placebo

4 tablet and 2 capsule placebos taken once daily

Sponsors & Collaborators

Principal Investigators

  • Novartis Japan · Sponsor GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00425373 on ClinicalTrials.gov