Safety and Efficacy Study of YM087 (Conivaptan) in Patients With Acute Decompensated Heart Failure
- Registration Number
- NCT00057356
- Lead Sponsor
- Cumberland Pharmaceuticals
- Brief Summary
This is a randomized, double-blind, placebo-controlled, dose ranging pilot study to examine the effects of conivaptan in patients with acute decompensated heart failure.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 170
- Patients may be male or female age 18 years or older.
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 placebo - 2 conivaptan Low dose 4 conivaptan High dose 3 conivaptan Middle dose
- Primary Outcome Measures
Name Time Method Change from baseline in respiratory Visual analog Scale (VAS) 48 hours
- Secondary Outcome Measures
Name Time Method Change from baseline in global VAS 48 hours Total urine output vs. baseline 72 hours
Trial Locations
- Locations (26)
Ohio State University Medical Center, Heart and Lung Research Institute
🇺🇸Columbus, Ohio, United States
University of Washington
🇺🇸Seattle, Washington, United States
The Heart Center, P.C.
🇺🇸Huntsville, Alabama, United States
San Joaquin Cardiology
🇺🇸Manteca, California, United States
LA County/USC Medical Center
🇺🇸Los Angeles, California, United States
Rush-Presbyterian St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Washington University
🇺🇸St. Louis, Missouri, United States
New York Presbyterian Hosp, Milstein Hosp.
🇺🇸New York, New York, United States
Apex Research Institute
🇺🇸Santa Ana, California, United States
Cardiovascular Research Institute of Dallas
🇺🇸Dallas, Texas, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Cardiac Centers of Louisiana, LLC
🇺🇸Shreveport, Louisiana, United States
Hennepin County Medical Center
🇺🇸Minneapolis, Minnesota, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
The Greater Fort Lauderdale Heart Group Research
🇺🇸Fort Lauderdale, Florida, United States
University of Maryland Hospital
🇺🇸Baltimore, Maryland, United States
U. Miami, Jackson Mem'l Medical Center
🇺🇸Miami, Florida, United States
Louisiana State University Medical Center School of Medicine
🇺🇸New Orleans, Louisiana, United States
Discovery Medical Research Group
🇺🇸Ocala, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
New Orleans Center for Clinical Research
🇺🇸New Orleans, Louisiana, United States
University of Cincinnati, College of Medicine, Div. of Cardiology
🇺🇸Cincinnati, Ohio, United States
Baptist Clinical Research
🇺🇸Memphis, Tennessee, United States