A Study of Valsartan Administered Once Daily Versus Twice Daily, in Patients With Stable, Chronic Heart Failure
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...
Brief Summary
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)”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
- Study Primary Completion Date: January 2007
Intervention(s) in this Clinical Trial
- Drug: valsartan 160 mg
- Drug: valsartan 160 mg BID
Outcome Measures for this Clinical Trial
Primary Measures
- 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 Measures
- 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
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Clinical Trial Investigator Information
Lead Investigator: Novartis Industry
Overall Clinical Trial Officials and Contacts
Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00294086
Study ID Number: CVAL489BUS70
ClinicalTrials.gov Identifier: NCT00294086
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00294086
