NCT00413049

Efficacy/Safety of Valsartan Plus Amlodipine and Amlodipine Alone in Patients With Hypertension

A Multi-national, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel Study Comparing the Efficacy and Safety of Valsartan/Amlodipine 80/5 mg to Amlodipine 5 mg Alone Once Daily in Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Amlodipine 5 mg Monotherapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 698 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and efficacy of the fixed combination of valsartan/amlodipine in adult patients with mild to moderate hypertension

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Valsartan/amlodipine 80/5 mg	1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
DRUG	Amlodipine 5 mg	1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.

Timeline

• Start date: 2007-01-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2006-12-19
• Last updated: 2011-04-29
• Results posted: 2011-02-08

Locations

12 sites across 1 country: China