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

Chronic Heart Failure Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00294086
• Other study ID #: CVAL489BUS70
• Status: Completed
• Phase: Phase 2
• First received: February 17, 2006
• Last updated: June 7, 2011
• Start date: December 2005
• Est. completion date: January 2007

Study information

• Verified date: June 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Drug:
• valsartan 160 mg

• valsartan 160 mg BID

Locations

Country	Name	City	State
United States	Novartis Pharmaceuticals	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patients reaching target dose at 10 weeks
Secondary	Change from baseline in systolic blood pressure at each study visit
Secondary	Change from baseline in diastolic blood pressure at each study visit
Secondary	Change from baseline in blood potassium at each study visit
Secondary	Change from baseline in blood creatinine at each study visit