NCT00425373

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

A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled, Factorial Study to Evaluate the Efficacy and Safety of 8-week Treatment With Valsartan (40 and 80 mg) and Amlodipine (2.5 and 5 mg) Combined and Alone in Essential Hypertensive Patients

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,474 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2006-11-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2007-01-23
• Last updated: 2011-04-29
• Results posted: 2011-02-04

Locations

1 site across 1 country: Japan