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

Condition(s) targeted: Hypertension

Intervention: valsartan plus hydrochlorothiazide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceutical, Study Director, Affiliation: Novartis

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.

Official title: 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

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline diastolic blood pressure after 8 weeks

Secondary outcome:

Change from baseline systolic blood pressure after 8 weeks

Diastolic blood pressure less than 90 mmHg or at least a 10 mmHg decrease in diastolic blood pressure after 8 weeks

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- - Male or female Outpatients 18 years and older.

- Patients with hypertension defined as the following:

- Newly diagnosed hypertensive patients should have a MSDBP > 95 mmHg and < 110 mmHg. at

Visit 1 and 2, Pre-treated hypertensive patients should have a MSDBP > 95 mmHg and < 110 mmHg at Visit 2

- For entrance into the double-blind treatment period (Visit 3), all patients should

have a MSDBP of > 90 mmHg and < 110 mmHg

- Patients must have given written informed consent to participate and be willing to

participate in the entire study

Exclusion Criteria:

-

Novartis Pharmaceuticals, East Hanover, New Jersey 07936, United States

Last updated: June 1, 2006