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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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valsartan plus hydrochlorothiazide

Intervention Type DRUG

Eligibility Criteria

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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