Safety and Efficacy Study of YM087 (Conivaptan) in Patients With Acute Decompensated Heart Failure

Condition(s) targeted: Chronic Heart Failure

Intervention: conivaptan (Drug); placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Use Central Contact, Study Director, Affiliation: Astellas Pharma US, Inc.

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.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Pilot Study Evaluating the Efficacy and Safety of YM087 in Patients With Decompensated Chronic Heart Failure

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline in respiratory Visual analog Scale (VAS)

Secondary outcome:

Change from baseline in global VAS

Total urine output vs. baseline

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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.

The Heart Center, P.C., Huntsville, Alabama 35801, United States

LA County/USC Medical Center, Los Angeles, California 90033, United States

San Joaquin Cardiology, Manteca, California 95337, United States

Apex Research Institute, Santa Ana, California 92705, United States

Jacksonville Center for Clinical Research, Jacksonville, Florida 32216, United States

U. Miami, Jackson Mem'l Medical Center, Miami, Florida 33136, United States

The Greater Fort Lauderdale Heart Group Research, Fort Lauderdale, Florida 33308, United States

Discovery Medical Research Group, Ocala, Florida 34478, United States

Rush-Presbyterian St. Luke's Medical Center, Chicago, Illinois 60612, United States

Cardiac Centers of Louisiana, LLC, Shreveport, Louisiana 71103, United States

Louisiana State University Medical Center School of Medicine, New Orleans, Louisiana 70112, United States

New Orleans Center for Clinical Research, New Orleans, Louisiana 70119, United States

University of Maryland Hospital, Baltimore, Maryland 20201, United States

Hennepin County Medical Center, Minneapolis, Minnesota 55415, United States

Washington University, St. Louis, Missouri 63110, United States

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire 03756, United States

New York Presbyterian Hosp, Milstein Hosp., New York, New York 10032, United States

Ohio State University Medical Center, Heart and Lung Research Institute, Columbus, Ohio 43210, United States

University of Cincinnati, College of Medicine, Div. of Cardiology, Cincinnati, Ohio 45267, United States

The Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States

Hershey Medical Center, Hershey, Pennsylvania 17033, United States

Medical University of South Carolina, Charleston, South Carolina 29425, United States

Baptist Clinical Research, Memphis, Tennessee 38120, United States

Cardiovascular Research Institute of Dallas, Dallas, Texas 75231, United States

Baylor College of Medicine, Houston, Texas 77030, United States

University of Washington, Seattle, Washington 98195, United States

Starting date: November 2002
Ending date: March 2004
Last updated: June 11, 2008