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

April 30, 2014 updated by: Cumberland Pharmaceuticals

A Randomized, Double-blind, Placebo-controlled, Dose-ranging Pilot Study Evaluating the Efficacy and Safety of YM087 in Patients With Decompensated Chronic Heart Failure

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

170

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Drug: placebo
IV
Experimental: 2
Low dose
Drug: conivaptan
IV
Other Names:
  • YM087
  • Vaprisol
Experimental: 3
Middle dose
Drug: conivaptan
IV
Other Names:
  • YM087
  • Vaprisol
Experimental: 4
High dose
Drug: conivaptan
IV
Other Names:
  • YM087
  • Vaprisol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in respiratory Visual analog Scale (VAS)
Time Frame: 48 hours
48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in global VAS
Time Frame: 48 hours
48 hours
Total urine output vs. baseline
Time Frame: 72 hours
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cumberland Pharmaceuticals

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Primary Completion (Actual)

March 1, 2004

Study Completion (Actual)

March 1, 2004

Study Registration Dates

First Submitted

March 31, 2003

First Submitted That Met QC Criteria

March 31, 2003

First Posted (Estimate)

April 1, 2003

Study Record Updates

Last Update Posted (Estimate)

May 2, 2014

Last Update Submitted That Met QC Criteria

April 30, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 087-CL-071

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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