Hypertension and Cardiovascular Risk Factors - Full Text View

Purpose

A study to evaluate the efficacy of valsartan+chydochlorothiazide in patients with stage 2 hypertension and cardiovascular risk factors.

Condition	Intervention	Phase
Hypertension	Drug: VALSARTAN+HYDROCHLOROTHIAZIDE	Phase IV

MedlinePlus related topics:

High Blood Pressure

Drug Information available for:

Valsartan Hydrochlorothiazide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Official Title:	Valsartan Plus Hydrochlorothiazide in Patients With Hypertension and Cardiovascular Risk Factors

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline systolic blood pressure at 8 weeks

Secondary Outcome Measures:

Blood pressure less than 140/90 mmHg at 8 weeks
Reduction from baseline in diastolic blood pressure greater than or equal to 10 mmHg
Reduction from baseline in systolic blood pressure greater than or equal to 20 mmHg

Estimated Enrollment:	74
Study Start Date:	February 2004

Eligibility

Ages Eligible for Study:

18 Years to 80 Years

Criteria

Inclusion Criteria:

- Patients who give consent
Men and women 18 to 80 years of age
Patients with hypertension (systolic >159 mm, diastolic >100 mm)
Patients meeting laboratory criteria

Exclusion Criteria:

- Pregnant women
Women not using approved contraception methods
Secondary hypertension

Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171782

Sponsors and Collaborators

Novartis

Investigators


Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information

Study ID Numbers:	CVAH631BCO02
First Received:	September 13, 2005
Last Updated:	June 1, 2006
ClinicalTrials.gov Identifier:	NCT00171782
Health Authority:	Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Novartis:

HYPERTENSION

VALSARTAN

VALSARTAN AND HYDROCHLOROTHIAZIDE

RISK FACTORS

Study placed in the following topic categories:

Vascular Diseases

Hydrochlorothiazide

Valsartan

Hypertension

Additional relevant MeSH terms:

Membrane Transport Modulators

Molecular Mechanisms of Pharmacological Action

Natriuretic Agents

Therapeutic Uses

Sodium Chloride Symporter Inhibitors

Physiological Effects of Drugs

Diuretics

Cardiovascular Diseases

Cardiovascular Agents

Antihypertensive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 06, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171782