Clinical trial NCT00057356: Safety and Efficacy Study of YM087 (Conivaptan) in Patients With Acute Decompensated Heart Failure
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Heart Failure
Keywords: Chronic Heart Failure
YM078
Lead sponsor: Cumberland Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2003-04-01
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change from baseline in respiratory Visual analog Scale (VAS)
timeFrame: 48 hours
Secondary outcomes:
measure: Change from baseline in global VAS
timeFrame: 48 hours
measure: Total urine output vs. baseline
timeFrame: 72 hours
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: The Heart Center, P.C.
state: Alabama
city: Los Angeles
country: United States
facility: LA County/USC Medical Center
state: California
city: Manteca
country: United States
facility: San Joaquin Cardiology
state: California
city: Santa Ana
country: United States
facility: Apex Research Institute
state: California
city: Fort Lauderdale
country: United States
facility: The Greater Fort Lauderdale Heart Group Research
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Miami
country: United States
facility: U. Miami, Jackson Mem'l Medical Center
state: Florida
city: Ocala
country: United States
facility: Discovery Medical Research Group
state: Florida
city: Chicago
country: United States
facility: Rush-Presbyterian St. Luke's Medical Center
state: Illinois
city: New Orleans
country: United States
facility: Louisiana State University Medical Center School of Medicine
state: Louisiana
city: New Orleans
country: United States
facility: New Orleans Center for Clinical Research
state: Louisiana
city: Shreveport
country: United States
facility: Cardiac Centers of Louisiana, LLC
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Hospital
state: Maryland
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: New York Presbyterian Hosp, Milstein Hosp.
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati, College of Medicine, Div. of Cardiology
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center, Heart and Lung Research Institute
state: Ohio
city: Hershey
country: United States
facility: Hershey Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: Baptist Clinical Research
state: Tennessee
city: Dallas
country: United States
facility: Cardiovascular Research Institute of Dallas
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Cumberland Pharmaceuticals, Inc.
name: Art Wheeler, MD
role: STUDY_DIRECTOR
References: