A Study of Valsartan Administered Once Daily Versus Twice Daily, in Patients With Stable, Chronic Heart Failure - Full Text View

Purpose

This study will evaluate the tolerability and safety of valsartan in patients with stable, chronic heart failure (NYHA Class ll-lll). The 12-week double blind study has a 2-week (maximum) screening, and a 10-week active treatment phase. In each of the treatment arms (QD and BID), patients are up-titrated to a maximum valsartan total daily dose of 320 mg. Patients remain on their prior CHF standard care therapy throughout the study period, and the up-titration of valsartan is based on patient tolerability.

Condition	Intervention	Phase
Chronic Heart Failure	Drug: valsartan 160 mg Drug: valsartan 160 mg BID	Phase II

MedlinePlus related topics:

Heart Failure

Drug Information available for:

Valsartan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A 12-Week Multicenter, 2-Arm Regimen, Exploratory Study to Evaluate the Tolerability and Safety of Valsartan Administered Once Daily vs Daily, in Patients With Stable, Chronic Heart Failure (NYHA Class ll-Lll)

Further study details as provided by Novartis:

Primary Outcome Measures:

Tolerability as assessed by laboratory tests for potassium, creatinine, and on systolic blood pressure, symptoms of low blood pressure, and symptoms of heart failure

Secondary Outcome Measures:

Patients reaching target dose at 10 weeks
Change from baseline in systolic blood pressure at each study visit
Change from baseline in diastolic blood pressure at each study visit
Change from baseline in blood potassium at each study visit
Change from baseline in blood creatinine at each study visit

Estimated Enrollment:	160
Study Start Date:	December 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria

Males or females aged 18 years or older
Diagnosis of chronic heart failure (CHF), in NYHA Class ll-lll beginning at least 3 months prior to Visit 1
Patients must remain on their prior standard care CHF therapy

Exclusion Criteria

Diagnosis of severe hypertension (SBP>180 and DBP>110 mm Hg)
Right heart failure due to pulmonary disease
Presence of rapidly deteriorating heart failure
MI or cardiac surgery, including PTCA within 3 months of Visit 1
Unstable angina or coronary artery disease likely to require CABG or PTCA
Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00294086

Locations


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

Sponsors and Collaborators

Novartis

Investigators


Study Director:	Novartis Pharmaceuticals

More Information

Study ID Numbers:	CVAL489BUS70
First Received:	February 17, 2006
Last Updated:	March 20, 2008
ClinicalTrials.gov Identifier:	NCT00294086
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

valsartan,

chronic heart failure,

Study placed in the following topic categories:

Heart Failure

Heart Diseases

Valsartan

Additional relevant MeSH terms:

Therapeutic Uses

Cardiovascular Diseases

Cardiovascular Agents

Antihypertensive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 29, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00294086