NCT00437645

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

A Double-blind, Randomized, Multicenter, Parallel Group Study to Evaluate the Efficacy, Tolerability, and Safety of Treatment With the Combination of Valsartan/Amlodipine 160/5 mg Compared to Amlodipine 10 mg in Patients With Essential Hypertension Not Adequately Controlled With Amlodipine 5 mg Alone

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,183 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

This study was designed to compare the efficacy, tolerability, and safety of the combination valsartan/amlodipine 160/5 mg versus amlodipine 10 mg in patients with essential hypertension not adequately controlled (defined as mean sitting systolic blood pressure \[msSBP\] ≥ 130 mmHg and ≤ 160 mmHg) on amlodipine 5 mg alone. The study evaluated both the efficacy and tolerability of the treatments by providing data that assessed blood pressure and the proportion of patients developing peripheral edema.

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
DRUG	Valsartan 160 mg capsules
DRUG	Amlodipine 5 mg capsules
DRUG	placebo	capsules

Timeline

• Start date: 2007-01-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2007-02-21
• Last updated: 2014-11-11
• Results posted: 2011-02-14

Locations

12 sites across 12 countries: Argentina, Chile, Ecuador, Finland, France, Germany, Italy, Norway, Spain, Sweden, Switzerland, Turkey (Türkiye)