A Study Comparing Valsartan With And Without Hydrochlorothiazide In Patients With Hypertension

This study has been completed.

First Received: October 14, 2005 Last Updated: June 1, 2006 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00241007

Purpose

SAFETY EXTENSION STUDY TO THE CORE STUDY CVAH631C2301

Condition	Intervention	Phase
Hypertension	Drug: VALSARTAN, VALSARTAN+HYDROCHLOROTHIAZIDE	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Study Comparing Valsartan With And Without Hydrochlorothiazide In Patients With Hypertension

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:

Adverse events and serious adverse events at each study visit for 54 weeks

Secondary Outcome Measures:

Change from baseline in diastolic blood pressure from baseline after 54 weeks
Change from baseline in systolic blood pressure from baseline after 54 weeks
Change from baseline in standing diastolic and systolic blood pressure after 54 weeks
Hematology and blood chemistries up to 54 weeks
Physical condition including pregnancy, pulse and weight at each study visit

Estimated Enrollment:	797
Study Start Date:	December 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

SUCCESSFUL COMPLETION OF STUDY CVAH631C2301

Exclusion Criteria:

NONE

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241007

Locations

United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	CVAH631C2301E1
Study First Received:	October 14, 2005
Last Updated:	June 1, 2006
ClinicalTrials.gov Identifier:	NCT00241007 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

HYPERTENSION, VALSARTAN

Study placed in the following topic categories:

Sodium Chloride Symporter Inhibitors
Diuretics
Vascular Diseases
Cardiovascular Agents

Antihypertensive Agents
Hydrochlorothiazide
Valsartan
Hypertension

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Hydrochlorothiazide

Pharmacologic Actions
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Valsartan
Hypertension

ClinicalTrials.gov processed this record on September 10, 2009