Back to resultsA Study of Valsartan Administered Once Daily Versus Twice Daily, in Patients With Stable, Chronic Heart Failure
Primary Purpose
Chronic Heart Failure
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
valsartan 160 mg
valsartan 160 mg BID
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Heart Failure focused on measuring valsartan,, chronic heart failure,
Eligibility Criteria
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.
Sites / Locations
- Novartis Pharmaceuticals
Outcomes
Primary Outcome 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 Outcome 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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00294086
Brief Title
A Study of Valsartan Administered Once Daily Versus Twice Daily, in Patients With Stable, Chronic Heart Failure
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
valsartan,, chronic heart failure,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
160 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
valsartan 160 mg
Intervention Type
Drug
Intervention Name(s)
valsartan 160 mg BID
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Patients reaching target dose at 10 weeks
Title
Change from baseline in systolic blood pressure at each study visit
Title
Change from baseline in diastolic blood pressure at each study visit
Title
Change from baseline in blood potassium at each study visit
Title
Change from baseline in blood creatinine at each study visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Pharmaceuticals
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20730060
Citation
Anand IS, Deswal A, Kereiakes DJ, Purkayastha D, Zappe DH. Comparison of once-daily versus twice-daily dosing of valsartan in patients with chronic stable heart failure. Vasc Health Risk Manag. 2010 Aug 9;6:449-55.
Results Reference
derived
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A Study of Valsartan Administered Once Daily Versus Twice Daily, in Patients With Stable, Chronic Heart Failure
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