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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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valsartan 160 mg

Intervention Type DRUG

valsartan 160 mg BID

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No