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

Primary Purpose

Chronic Heart Failure

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
conivaptan
placebo
Sponsored by
Cumberland Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring Chronic Heart Failure, YM078

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Heart Center, P.C.
  • LA County/USC Medical Center
  • San Joaquin Cardiology
  • Apex Research Institute
  • The Greater Fort Lauderdale Heart Group Research
  • Jacksonville Center for Clinical Research
  • U. Miami, Jackson Mem'l Medical Center
  • Discovery Medical Research Group
  • Rush-Presbyterian St. Luke's Medical Center
  • Louisiana State University Medical Center School of Medicine
  • New Orleans Center for Clinical Research
  • Cardiac Centers of Louisiana, LLC
  • University of Maryland Hospital
  • Hennepin County Medical Center
  • Washington University
  • Dartmouth-Hitchcock Medical Center
  • New York Presbyterian Hosp, Milstein Hosp.
  • University of Cincinnati, College of Medicine, Div. of Cardiology
  • The Cleveland Clinic Foundation
  • Ohio State University Medical Center, Heart and Lung Research Institute
  • Hershey Medical Center
  • Medical University of South Carolina
  • Baptist Clinical Research
  • Cardiovascular Research Institute of Dallas
  • Baylor College of Medicine
  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

Arm Description

Low dose

Middle dose

High dose

Outcomes

Primary Outcome Measures

Change from baseline in respiratory Visual analog Scale (VAS)

Secondary Outcome Measures

Change from baseline in global VAS
Total urine output vs. baseline

Full Information

First Posted
March 31, 2003
Last Updated
April 30, 2014
Sponsor
Cumberland Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00057356
Brief Title
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

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
March 2004 (Actual)
Study Completion Date
March 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cumberland Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
Chronic Heart Failure, YM078

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Experimental
Arm Description
Low dose
Arm Title
3
Arm Type
Experimental
Arm Description
Middle dose
Arm Title
4
Arm Type
Experimental
Arm Description
High dose
Intervention Type
Drug
Intervention Name(s)
conivaptan
Other Intervention Name(s)
Vaprisol, YM087
Intervention Description
IV
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
IV
Primary Outcome Measure Information:
Title
Change from baseline in respiratory Visual analog Scale (VAS)
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Change from baseline in global VAS
Time Frame
48 hours
Title
Total urine output vs. baseline
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Art Wheeler, MD
Organizational Affiliation
Cumberland Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
The Heart Center, P.C.
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
LA County/USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
San Joaquin Cardiology
City
Manteca
State/Province
California
ZIP/Postal Code
95337
Country
United States
Facility Name
Apex Research Institute
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
The Greater Fort Lauderdale Heart Group Research
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
U. Miami, Jackson Mem'l Medical Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Discovery Medical Research Group
City
Ocala
State/Province
Florida
ZIP/Postal Code
34478
Country
United States
Facility Name
Rush-Presbyterian St. Luke's Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Louisiana State University Medical Center School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
New Orleans Center for Clinical Research
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
Facility Name
Cardiac Centers of Louisiana, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
University of Maryland Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
20201
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Washington University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
New York Presbyterian Hosp, Milstein Hosp.
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Cincinnati, College of Medicine, Div. of Cardiology
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University Medical Center, Heart and Lung Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Baptist Clinical Research
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Cardiovascular Research Institute of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

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

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