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

Completed · Phase 2

Conditions studied: Chronic Heart Failure

In brief

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.

Key facts

Study ID

NCT00294086

Run by

Novartis

People needed

160

Starts

2005-12-01

Expected to finish

2007-01-01

Last updated by the study team

2011-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Novartis Pharmaceuticals — East Hanover, New Jersey, United States

Full record on ClinicalTrials.gov

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