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

Novartis

Status and phase: Completed; Phase 2

Conditions: Chronic Heart Failure

Treatments: Drug: valsartan 160 mg; Drug: valsartan 160 mg BID

Study type: Interventional

Funder types: Industry

Identifiers

NCT00294086

CVAL489BUS70

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind