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)
1 other identifier
interventional
160
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2005
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 17, 2006
CompletedFirst Posted
Study publicly available on registry
February 20, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedJune 8, 2011
June 1, 2011
1.1 years
February 17, 2006
June 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (1)
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936, United States
Related Publications (1)
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.
PMID: 20730060DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 17, 2006
First Posted
February 20, 2006
Study Start
December 1, 2005
Primary Completion
January 1, 2007
Study Completion
January 1, 2007
Last Updated
June 8, 2011
Record last verified: 2011-06