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

This study has been completed.
Information provided by (Responsible Party):
Novartis Identifier:
First received: November 6, 2005
Last updated: April 20, 2017
Last verified: November 2016

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.

Condition Intervention Phase
Drug: valsartan plus hydrochlorothiazide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (masked roles unspecified)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline diastolic blood pressure after 8 weeks

Secondary Outcome Measures:
  • 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

Enrollment: 1171
Study Start Date: October 2005
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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 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:

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Please refer to this study by its identifier: NCT00250562

United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Study Director: Novartis Pharmaceutical Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Identifier: NCT00250562     History of Changes
Other Study ID Numbers: CVAH631A2302
Study First Received: November 6, 2005
Last Updated: April 20, 2017

Keywords provided by Novartis:
Angiotensin II receptor blocker
fixed combination

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists processed this record on April 25, 2017