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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00250562

Enrollment

1171

Registered

2005-11-08

Start date

2005-10-31

Completion date

2006-06-30

Last updated

2017-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Hypertension, Angiotensin II receptor blocker, fixed combination, diuretics

Brief 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.

Interventions

DRUGvalsartan plus hydrochlorothiazide

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Change from baseline diastolic blood pressure after 8 weeks	—

Secondary

Measure	Time frame
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026