Safety and Efficacy Study of YM087 (Conivaptan) in Patients With Acute Decompensated Heart Failure
NCT ID: NCT00057356
Last Updated: 2014-05-02
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
170 participants
INTERVENTIONAL
2002-11-30
2004-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
placebo
IV
2
Low dose
conivaptan
IV
3
Middle dose
conivaptan
IV
4
High dose
conivaptan
IV
Interventions
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conivaptan
IV
placebo
IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Women must be post-menopausal or surgically sterile.
* Patients must have chronic heart failure of at least 2 months duration and be hospitalized for the treatment of worsening heart failure. The primary manifestation of worsening heart failure must be worsening dyspnea.
18 Years
ALL
No
Sponsors
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Cumberland Pharmaceuticals
INDUSTRY
Responsible Party
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Astellas Pharma US, Inc.
Principal Investigators
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Art Wheeler, MD
Role: STUDY_DIRECTOR
Cumberland Pharmaceuticals, Inc.
Locations
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The Heart Center, P.C.
Huntsville, Alabama, United States
LA County/USC Medical Center
Los Angeles, California, United States
San Joaquin Cardiology
Manteca, California, United States
Apex Research Institute
Santa Ana, California, United States
The Greater Fort Lauderdale Heart Group Research
Fort Lauderdale, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
U. Miami, Jackson Mem'l Medical Center
Miami, Florida, United States
Discovery Medical Research Group
Ocala, Florida, United States
Rush-Presbyterian St. Luke's Medical Center
Chicago, Illinois, United States
Louisiana State University Medical Center School of Medicine
New Orleans, Louisiana, United States
New Orleans Center for Clinical Research
New Orleans, Louisiana, United States
Cardiac Centers of Louisiana, LLC
Shreveport, Louisiana, United States
University of Maryland Hospital
Baltimore, Maryland, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Washington University
St Louis, Missouri, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
New York Presbyterian Hosp, Milstein Hosp.
New York, New York, United States
University of Cincinnati, College of Medicine, Div. of Cardiology
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University Medical Center, Heart and Lung Research Institute
Columbus, Ohio, United States
Hershey Medical Center
Hershey, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Baptist Clinical Research
Memphis, Tennessee, United States
Cardiovascular Research Institute of Dallas
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Washington
Seattle, Washington, United States
Countries
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Other Identifiers
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087-CL-071
Identifier Type: -
Identifier Source: org_study_id
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