- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00294086
A Study of Valsartan Administered Once Daily Versus Twice Daily, in Patients With Stable, Chronic Heart Failure
June 7, 2011 updated by: Novartis
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
160
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Jersey
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East Hanover, New Jersey, United States, 07936
- Novartis Pharmaceuticals
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Tolerability as assessed by laboratory tests for potassium, creatinine, and on systolic blood pressure, symptoms of low blood pressure, and symptoms of heart failure
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Secondary Outcome Measures
Outcome Measure |
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Patients reaching target dose at 10 weeks
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Change from baseline in systolic blood pressure at each study visit
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Change from baseline in diastolic blood pressure at each study visit
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Change from baseline in blood potassium at each study visit
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Change from baseline in blood creatinine at each study visit
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2005
Primary Completion (Actual)
January 1, 2007
Study Completion (Actual)
January 1, 2007
Study Registration Dates
First Submitted
February 17, 2006
First Submitted That Met QC Criteria
February 17, 2006
First Posted (Estimate)
February 20, 2006
Study Record Updates
Last Update Posted (Estimate)
June 8, 2011
Last Update Submitted That Met QC Criteria
June 7, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CVAL489BUS70
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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