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

NCT ID: NCT00057356

Last Updated: 2014-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2004-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

IV

2

Low dose

Group Type EXPERIMENTAL

conivaptan

Intervention Type DRUG

IV

3

Middle dose

Group Type EXPERIMENTAL

conivaptan

Intervention Type DRUG

IV

4

High dose

Group Type EXPERIMENTAL

conivaptan

Intervention Type DRUG

IV

Interventions

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conivaptan

IV

Intervention Type DRUG

placebo

IV

Intervention Type DRUG

Other Intervention Names

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Vaprisol YM087

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cumberland Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Astellas Pharma US, Inc.

Principal Investigators

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Art Wheeler, MD

Role: STUDY_DIRECTOR

Cumberland Pharmaceuticals, Inc.

Locations

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The Heart Center, P.C.

Huntsville, Alabama, United States

Site Status

LA County/USC Medical Center

Los Angeles, California, United States

Site Status

San Joaquin Cardiology

Manteca, California, United States

Site Status

Apex Research Institute

Santa Ana, California, United States

Site Status

The Greater Fort Lauderdale Heart Group Research

Fort Lauderdale, Florida, United States

Site Status

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Site Status

U. Miami, Jackson Mem'l Medical Center

Miami, Florida, United States

Site Status

Discovery Medical Research Group

Ocala, Florida, United States

Site Status

Rush-Presbyterian St. Luke's Medical Center

Chicago, Illinois, United States

Site Status

Louisiana State University Medical Center School of Medicine

New Orleans, Louisiana, United States

Site Status

New Orleans Center for Clinical Research

New Orleans, Louisiana, United States

Site Status

Cardiac Centers of Louisiana, LLC

Shreveport, Louisiana, United States

Site Status

University of Maryland Hospital

Baltimore, Maryland, United States

Site Status

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

New York Presbyterian Hosp, Milstein Hosp.

New York, New York, United States

Site Status

University of Cincinnati, College of Medicine, Div. of Cardiology

Cincinnati, Ohio, United States

Site Status

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Ohio State University Medical Center, Heart and Lung Research Institute

Columbus, Ohio, United States

Site Status

Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Baptist Clinical Research

Memphis, Tennessee, United States

Site Status

Cardiovascular Research Institute of Dallas

Dallas, Texas, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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087-CL-071

Identifier Type: -

Identifier Source: org_study_id

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