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

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

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 2

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 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)

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure Potassium

Drug Information available for: Valsartan

U.S. FDA Resources

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
Study Completion Date:	January 2007
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

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

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Anand IS, Deswal A, Kereiakes DJ, Purkayastha D, Zappe DH. Comparison of once-daily versus twice-daily dosing of valsartan in patients with chronic stable heart failure. Vasc Health Risk Manag. 2010 Aug 9;6:449-55.

Responsible Party:	Study Director, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00294086 History of Changes
Other Study ID Numbers:	CVAL489BUS70
Study First Received:	February 17, 2006
Last Updated:	June 7, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

valsartan,
chronic heart failure,

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases
Valsartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2012