Clinical Trials Directory

Trials / Completed

CompletedNCT00250562

A Study in Chinese Mild to Moderate Hypertensive Patients Comparing the Efficacy of Co-Diovan With Diovan.

A Multicenter, Double-blind, Randomized, Active Controlled, Parallel Group Trial Comparing the Combinations of Valsartan 80 mg Plus Hydrochlorothiazide 12.5 mg to Valsartan 80 mg in Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Valsartan 80mg

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
1,171 (actual)
Sponsor
Novartis · Industry
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

Valsartan, an orally active angiotensin II receptor blocker, is registered in most countries worldwide for the treatment of hypertension. In China the usual recommended starting and maintenance dose is 80 mg o.d. The combination of HCTZ 12.5 mg with valsartan 80 mg has been shown to have additive effects in lowering blood pressure compared to valsartan 80 mg in patients not adequately controlled by valsartan 80 mg monotherapy5 or in non-selected patients6. This fixed combination is registered in most countries worldwide. The potential benefits of these combinations should be evaluated in patients not adequately controlled by valsartan 80 mg monotherapy. This study will compare the efficacy, safety and tolerability of adding HCTZ 12.5 mg to valsartan 80 mg in those hypertensive patients. This study is not recruiting in the US.

Conditions

Interventions

TypeNameDescription
DRUGvalsartan plus hydrochlorothiazide

Timeline

Start date
2005-10-01
Primary completion
2006-06-01
Completion
2006-06-01
First posted
2005-11-08
Last updated
2017-08-01

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00250562. Inclusion in this directory is not an endorsement.