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

Novartis1,171 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,171

Conditions

Hypertension

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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: \-

Outcomes

Primary Outcomes

Change from baseline diastolic blood pressure after 8 weeks

Secondary Outcomes

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