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

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2

Details

• Lead Sponsor: Novartis
• Treatments: Valsartan

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.