NCT01001572

Efficacy and Safety of Valsartan/Amlodipine in Patients With Mild to Moderate Essential Hypertension

A Multi-national, Multi-center, Double-blind, Randomized, Parallel Study Comparing the Efficacy and Safety of Valsartan/Amlodipine 160/5 mg to Valsartan 160 mg Alone in Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Valsartan 160 mg Monotherapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 932 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study assessed the efficacy and safety of the valsartan/amlodipine 160/5 mg single-pill combination in patients with uncomplicated essential hypertension not adequately controlled (MSDBP ≥90 mmHg and \<110 mmHg) on valsartan 160 mg alone.

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
DRUG	Valsartan/amlodipine 160/5 mg	Valsartan/amlodipine 160/5mg film coated tablets taken orally once daily.
DRUG	Valsartan 160 mg	Valsartan 160 mg capsule taken orally once daily.
DRUG	Placebo	1 capsule or tablet taken orally once daily

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2009-10-26
• Last updated: 2011-05-24
• Results posted: 2011-05-24