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

Sponsor
Cumberland Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00057356
Collaborator
(none)
170
Enrollment
26
Locations
4
Arms
16
Duration (Months)
6.5
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
170 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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 Start Date :
Nov 1, 2002
Actual Primary Completion Date :
Mar 1, 2004
Actual Study Completion Date :
Mar 1, 2004

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: 1

Drug: placebo
IV
Experimental: 2

Low dose

Drug: conivaptan
IV
Other Names:
  • Vaprisol
  • YM087

    		•
    Experimental: 3

    Middle dose

    Drug: conivaptan
    IV
    Other Names:
  • Vaprisol
  • YM087

    		•
    Experimental: 4

    High dose

    Drug: conivaptan
    IV
    Other Names:
  • Vaprisol
  • YM087

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in respiratory Visual analog Scale (VAS) [48 hours]

    Secondary Outcome Measures

    1. Change from baseline in global VAS [48 hours]

    2. Total urine output vs. baseline [72 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

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

    Sponsors and Collaborators

    • Cumberland Pharmaceuticals

    Investigators

    • Study Director: Art Wheeler, MD, Cumberland Pharmaceuticals, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00057356
    Other Study ID Numbers:
    • 087-CL-071
    First Posted:
    Apr 1, 2003
    Last Update Posted:
    May 2, 2014
    Last Verified:
    Apr 1, 2014
    Keywords provided by , ,
    Chronic Heart Failure
    YM078
    Additional relevant MeSH terms:
    Heart Failure
    Conivaptan

    Study Results

    No Results Posted as of May 2, 2014