NCT00057356

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2002

Shorter than P25 for phase_2

Geographic Reach
1 country

26 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 1, 2003

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
Last Updated

May 2, 2014

Status Verified

April 1, 2014

Enrollment Period

1.3 years

First QC Date

March 31, 2003

Last Update Submit

April 30, 2014

Conditions

Chronic Heart Failure

Keywords

Chronic Heart FailureYM078

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in respiratory Visual analog Scale (VAS)

    48 hours

Secondary Outcomes (2)

  • Change from baseline in global VAS

    48 hours

  • Total urine output vs. baseline

    72 hours

Study Arms (4)

1

PLACEBO COMPARATOR
Drug: placebo

2

EXPERIMENTAL

Low dose

Drug: conivaptan

3

EXPERIMENTAL

Middle dose

Drug: conivaptan

4

EXPERIMENTAL

High dose

Drug: conivaptan

Interventions

conivaptanDRUG

IV

Also known as: Vaprisol, YM087
234
placeboDRUG

IV

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

The Heart Center, P.C.

Huntsville, Alabama, 35801, United States

Location

LA County/USC Medical Center

Los Angeles, California, 90033, United States

Location

San Joaquin Cardiology

Manteca, California, 95337, United States

Location

Apex Research Institute

Santa Ana, California, 92705, United States

Location

The Greater Fort Lauderdale Heart Group Research

Fort Lauderdale, Florida, 33308, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

U. Miami, Jackson Mem'l Medical Center

Miami, Florida, 33136, United States

Location

Discovery Medical Research Group

Ocala, Florida, 34478, United States

Location

Rush-Presbyterian St. Luke's Medical Center

Chicago, Illinois, 60612, United States

Location

Louisiana State University Medical Center School of Medicine

New Orleans, Louisiana, 70112, United States

Location

New Orleans Center for Clinical Research

New Orleans, Louisiana, 70119, United States

Location

Cardiac Centers of Louisiana, LLC

Shreveport, Louisiana, 71103, United States

Location

University of Maryland Hospital

Baltimore, Maryland, 20201, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

New York Presbyterian Hosp, Milstein Hosp.

New York, New York, 10032, United States

Location

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

Cincinnati, Ohio, 45267, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University Medical Center, Heart and Lung Research Institute

Columbus, Ohio, 43210, United States

Location

Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Baptist Clinical Research

Memphis, Tennessee, 38120, United States

Location

Cardiovascular Research Institute of Dallas

Dallas, Texas, 75231, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Interventions

conivaptan

Study Officials

  • Art Wheeler, MD

    Cumberland Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 31, 2003

First Posted

April 1, 2003

Study Start

November 1, 2002

Primary Completion

March 1, 2004

Study Completion

March 1, 2004

Last Updated

May 2, 2014

Record last verified: 2014-04

Locations

US(26)