Hypertension and Cardiovascular Risk Factors

This study has been completed.

First Received on September 13, 2005. Last Updated on November 7, 2011 History of Changes

Sponsor:	Novartis
Information provided by (Responsible Party):	Novartis
ClinicalTrials.gov Identifier:	NCT00171782

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Valsartan Plus Hydrochlorothiazide in Patients With Hypertension and Cardiovascular Risk Factors

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 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

Enrollment:	76
Study Start Date:	February 2004
Study Completion Date:	December 2004
Primary Completion Date:	December 2004 (Final data collection date for primary outcome measure)

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

More Information

No publications provided

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00171782 History of Changes
Other Study ID Numbers:	CVAH631BCO02
Study First Received:	September 13, 2005
Last Updated:	November 7, 2011
Health Authority:	Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Novartis:

HYPERTENSION
VALSARTAN
VALSARTAN AND HYDROCHLOROTHIAZIDE
RISK FACTORS

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