NCT00400777

Efficacy and Safety of Valsartan, Hydrochlorothiazide and Amlodipine Combination Therapy in Hypertension

An Open-Label, Randomized, Multicenter Study to Evaluate the Efficacy of the Combination of Valsartan and Hydrochlorothiazide and Amlodipine in Hypertensive Patients Not Controlled With Valsartan and Hydrochlorothiazide

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 460 (estimated)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the efficacy and safety of the combination valsartan with hydrochlorothiazide and amlodipine in hypertensive patients previously treated with valsartan with hydrochlorothiazide and remaining uncontrolled. A naturalistic approach will be taken comparing two different possible ways to achieve the higher dosage of the triple combination, i.e. 160 mg of valsartan and 25 mg of hydrochlorothiazide with amlodipine 10 mg.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Valsartan, hydrochlorothiazide and amlodipine

Timeline

• Start date: 2006-08-01
• Primary completion: 2007-11-01
• Completion: 2008-06-01
• First posted: 2006-11-17
• Last updated: 2008-06-18

Locations

1 site across 1 country: Brazil