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

This study has been completed.

First Received on October 14, 2005. Last Updated on November 7, 2011 History of Changes

Sponsor:	Novartis
Information provided by (Responsible Party):	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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Enrollment:	836
Study Start Date:	December 2003
Study Completion Date:	March 2005
Primary Completion Date:	March 2005 (Final data collection date for primary outcome measure)

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

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00241007 History of Changes
Other Study ID Numbers:	CVAH631C2301E1
Study First Received:	October 14, 2005
Last Updated:	November 7, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

HYPERTENSION, VALSARTAN

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