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)”

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.

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: valsartan 160 mg
• Drug: valsartan 160 mg BID

Primary 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 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

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director   

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00294086

Study ID Number: CVAL489BUS70

ClinicalTrials.gov Identifier: NCT00294086

Health Authority: United States: Food and Drug Administration