A Study of VAH631 in Patients With Essential Hypertension (Factorial Study) - Full Text View

Sponsor:	Novartis
Information provided by (Responsible Party):	Novartis
ClinicalTrials.gov Identifier:	NCT00311740

Purpose

The purpose of this study is to compare the effect of the fixed combination of valsartan+hydrochlorothiazide (HCTZ) on blood pressure reduction with valsartan and HCTZ alone and whether the combination treatments are safe and well tolerated. The study aims to establish a dose response relationship for both monotherapies and the combinations.

This study is being conducted in Japan.

Condition	Intervention	Phase
Hypertension	Drug: Valsartan Drug: Hydrochlorothiazide	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Multi-center, Factorial Study to Evaluate Efficacy & Safety of 8 Wks Treatment With VAH631 [Valsartan (40 & 80 mg) and Hydrochlorothiazide (6.25 & 12.5 mg) Combined & Alone in Essential Hypertensive Patients] - Double-blind Study of VAH631 in Patients With Essential Hypertension (Factorial Study)

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Valsartan

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in diastolic blood pressure after 8 weeks

Secondary Outcome Measures:

Change from baseline in 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
Change from baseline in standing diastolic blood pressure after 8 weeks
Change from baseline in standing systolic blood pressure after 8 weeks
Adverse events and serious adverse events at each study visit for 8 weeks

Enrollment:	582
Study Start Date:	March 2006
Study Completion Date:	September 2006
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Essential hypertension measured by mercury sphygmomanometer
Outpatients

Exclusion Criteria:

Secondary hypertension or suspected of having secondary hypertension.
A history of malignant hypertension
Severe hypertension
Significant heart, renal, hepatic diseases or significant cerebrovascular disorder
Gout Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311740

Locations

Japan
Novartis Pharmaceuticals
Tokyo, Japan

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

Novatis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00311740 History of Changes
Other Study ID Numbers:	CVAH631B1303
Study First Received:	April 4, 2006
Last Updated:	November 7, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:

Hypertension,
Valsartan,
Hydrochlorothiazide

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Valsartan
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions

Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on February 09, 2012