Safety Study of Vasopressin V2 Receptor Antagonist on Patients With Severe Chronic Heart Failure (AQUAVIT).
NCT ID: NCT00032747
Last Updated: 2008-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
338 participants
INTERVENTIONAL
2001-08-31
2003-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Vasopressin V2 Receptor Antagonist
Eligibility Criteria
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Inclusion Criteria
* Women must be post-menopausal or surgically sterilized; they cannot be pregnant or nursing.
* Age 21 to 80 years.
* Chronic heart failure of at least 3 months duration. For 2 months prior to screening, patients must have had symptoms at rest or on minimal exertion for more than 50% of the time. For 2 weeks prior to screening, patients must have had symptoms at rest or on minimal exertion for more than 90% of the time.
* Patients must be receiving a diuretic and an ACE inhibitor (or an angiotensin II receptor antagonist) for the treatment of heart failure.
* Patients may be receiving digoxin, a beta-blocker or spironolactone
18 Years
80 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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ICD CSD
Role: STUDY_DIRECTOR
Sanofi
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Emory University
Atlanta, Georgia, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
Brian LGH Heart Institute
Lincoln, Nebraska, United States
The Lindner Clinical Trial Center
Cincinnati, Ohio, United States
MUSC/Division Cardiology
Charleston, South Carolina, United States
Sanofi-aventis Administrative Office
Laval, , Canada
Sanofi-aventis Administrative Office
Guildford Surrey, , United Kingdom
Countries
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Related Links
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Related Info
Related Info
Other Identifiers
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SR121463B
Identifier Type: -
Identifier Source: secondary_id
DFI4510
Identifier Type: -
Identifier Source: org_study_id