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

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00294086

Enrollment

160

Registered

2006-02-20

Start date

2005-12-31

Completion date

2007-01-31

Last updated

2011-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Heart Failure

Keywords

valsartan,, chronic heart failure,

Brief 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.

Interventions

DRUGvalsartan 160 mg

DRUGvalsartan 160 mg BID

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026