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CompletedNCT00057356Updated May 2, 2014

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

A Phase 2 interventional study of conivaptan and placebo in Chronic Heart Failure, sponsored by Cumberland Pharmaceuticals. Completed at 26 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-02.

Sponsored by Cumberland Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
170
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Heart Failure

Browse trials for

Keywords

  • Chronic Heart Failure
  • YM078
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 170 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Cumberland Pharmaceuticals is the lead sponsor of 47 studies on the registry; 1 is open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
170 participants (actual)

Study arms

  • Placebo comparator
    1

    Drug: placebo

  • Experimental
    2

    Low dose

    Drug: conivaptan

  • Experimental
    3

    Middle dose

    Drug: conivaptan

  • Experimental
    4

    High dose

    Drug: conivaptan

Interventions

  • Drugconivaptan

    IV

    Also known as: Vaprisol, YM087

  • Drugplacebo

    IV

06

What researchers measure

Primary outcomes

  1. Change from baseline in respiratory Visual analog Scale (VAS)

    Time frame: 48 hours

Secondary outcomes

  1. Change from baseline in global VAS

    Time frame: 48 hours

  2. Total urine output vs. baseline

    Time frame: 72 hours

07

Study locations

26 sites
  • 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
  • The Greater Fort Lauderdale Heart Group Research
    Fort Lauderdale, Florida 33308, United States
  • Jacksonville Center for Clinical Research
    Jacksonville, Florida 32216, United States
  • U. Miami, Jackson Mem'l Medical Center
    Miami, Florida 33136, United States
  • Discovery Medical Research Group
    Ocala, Florida 34478, United States
  • Rush-Presbyterian St. Luke's Medical Center
    Chicago, Illinois 60612, 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
  • Cardiac Centers of Louisiana, LLC
    Shreveport, Louisiana 71103, 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
  • University of Cincinnati, College of Medicine, Div. of Cardiology
    Cincinnati, Ohio 45267, United States
  • The Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
  • Ohio State University Medical Center, Heart and Lung Research Institute
    Columbus, Ohio 43210, 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00057356
Lead sponsor
Cumberland Pharmaceuticals
First posted
Apr 1, 2003
Start date
Nov 2002
Primary completion
Mar 2004
Completion
Mar 2004
Last update
May 2, 2014

Study contacts

Art Wheeler, MD
study director · Cumberland Pharmaceuticals, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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