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

Chronic Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00057356
• Other study ID #: 087-CL-071
• Status: Completed
• Phase: Phase 2
• First received: March 31, 2003
• Last updated: April 30, 2014
• Start date: November 2002
• Est. completion date: March 2004

Study information

• Verified date: April 2014
• Source: Cumberland Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: March 2004
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Drug:
• conivaptan
IV
• placebo
IV

Locations

Country	Name	City	State
United States	University of Maryland Hospital	Baltimore	Maryland
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Rush-Presbyterian St. Luke's Medical Center	Chicago	Illinois
United States	University of Cincinnati, College of Medicine, Div. of Cardiology	Cincinnati	Ohio
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Ohio State University Medical Center, Heart and Lung Research Institute	Columbus	Ohio
United States	Cardiovascular Research Institute of Dallas	Dallas	Texas
United States	The Greater Fort Lauderdale Heart Group Research	Fort Lauderdale	Florida
United States	Hershey Medical Center	Hershey	Pennsylvania
United States	Baylor College of Medicine	Houston	Texas
United States	The Heart Center, P.C.	Huntsville	Alabama
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	LA County/USC Medical Center	Los Angeles	California
United States	San Joaquin Cardiology	Manteca	California
United States	Baptist Clinical Research	Memphis	Tennessee
United States	U. Miami, Jackson Mem'l Medical Center	Miami	Florida
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	Louisiana State University Medical Center School of Medicine	New Orleans	Louisiana
United States	New Orleans Center for Clinical Research	New Orleans	Louisiana
United States	New York Presbyterian Hosp, Milstein Hosp.	New York	New York
United States	Discovery Medical Research Group	Ocala	Florida
United States	Apex Research Institute	Santa Ana	California
United States	University of Washington	Seattle	Washington
United States	Cardiac Centers of Louisiana, LLC	Shreveport	Louisiana
United States	Washington University	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Cumberland Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in respiratory Visual analog Scale (VAS)		48 hours	No
Secondary	Change from baseline in global VAS		48 hours	No
Secondary	Total urine output vs. baseline		72 hours	No