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

Sponsor:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00057356

Purpose

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.

Condition	Intervention	Phase
Chronic Heart Failure	Drug: conivaptan Drug: placebo	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: YM 087 Conivaptan

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Change from baseline in respiratory Visual analog Scale (VAS) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in global VAS [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Total urine output vs. baseline [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Enrollment:	170
Study Start Date:	November 2002
Study Completion Date:	March 2004
Primary Completion Date:	March 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: placebo IV
2: Experimental Low dose	Drug: conivaptan IV
3: Experimental Middle dose	Drug: conivaptan IV
4: Experimental High dose	Drug: conivaptan IV

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057356

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Locations

United States, Alabama
The Heart Center, P.C.
Huntsville, Alabama, United States, 35801
United States, California
LA County/USC Medical Center
Los Angeles, California, United States, 90033
San Joaquin Cardiology
Manteca, California, United States, 95337
Apex Research Institute
Santa Ana, California, United States, 92705
United States, Florida
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
U. Miami, Jackson Mem'l Medical Center
Miami, Florida, United States, 33136
The Greater Fort Lauderdale Heart Group Research
Fort Lauderdale, Florida, United States, 33308
Discovery Medical Research Group
Ocala, Florida, United States, 34478
United States, Illinois
Rush-Presbyterian St. Luke's Medical Center
Chicago, Illinois, United States, 60612
United States, Louisiana
Cardiac Centers of Louisiana, LLC
Shreveport, Louisiana, United States, 71103
Louisiana State University Medical Center School of Medicine
New Orleans, Louisiana, United States, 70112
New Orleans Center for Clinical Research
New Orleans, Louisiana, United States, 70119
United States, Maryland
University of Maryland Hospital
Baltimore, Maryland, United States, 20201
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
New York Presbyterian Hosp, Milstein Hosp.
New York, New York, United States, 10032
United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
University of Cincinnati, College of Medicine, Div. of Cardiology
Cincinnati, Ohio, United States, 45267
Ohio State University Medical Center, Heart and Lung Research Institute
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Baptist Clinical Research
Memphis, Tennessee, United States, 38120
United States, Texas
Cardiovascular Research Institute of Dallas
Dallas, Texas, United States, 75231
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Washington
University of Washington
Seattle, Washington, United States, 98195

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Use Central Contact

Astellas Pharma US, Inc.

More Information

Additional Information:

Link to results on ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Astellas Pharma US, Inc. ( Sr Manager Clinical Trials Registry )
Study ID Numbers:	087-CL-071
Study First Received:	March 31, 2003
Last Updated:	June 26, 2008
ClinicalTrials.gov Identifier:	NCT00057356 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:

Chronic Heart Failure
YM078

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 25, 2009