Study to Compare the Effects of Two Dosages of Tolvaptan in Congestive Heart Failure Patients
Primary Purpose
Congestive Heart Failure
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tolvaptan
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring CHF
Eligibility Criteria
History of CHF
Sites / Locations
- Central Cardiology Medical Clinic
- University of California-San Diego
- University of Miami/Jackson Memorial Hospital
- Medical Research Institute
- Androscoggin Cardiology Associates
- University of Missouri-Kansas City School of Medicine
- Saint Louis University
- Cardiology of Oklahoma
- Medical University of South Carolina
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00043771
First Posted
August 13, 2002
Last Updated
June 23, 2005
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00043771
Brief Title
Study to Compare the Effects of Two Dosages of Tolvaptan in Congestive Heart Failure Patients
Official Title
Multi-Center, Double-Blind Study to Compare the Effects of 30mg Qd Versus 15 Mg Bid of Tolvaptan in Congestive Heart Failure Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2002
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2002 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
4. Oversight
5. Study Description
Brief Summary
Patients with congestive heart failure will be assessed for safety and clinical effects of Tolvaptan 30 mg every day versus 15 mg twice a day over a period of 7 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
CHF
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tolvaptan
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
History of CHF
Facility Information:
Facility Name
Central Cardiology Medical Clinic
City
Bakersfield
State/Province
California
Country
United States
Facility Name
University of California-San Diego
City
San Diego
State/Province
California
Country
United States
Facility Name
University of Miami/Jackson Memorial Hospital
City
Miami
State/Province
Florida
Country
United States
Facility Name
Medical Research Institute
City
Slidell
State/Province
Louisiana
Country
United States
Facility Name
Androscoggin Cardiology Associates
City
Auburn
State/Province
Maine
Country
United States
Facility Name
University of Missouri-Kansas City School of Medicine
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Saint Louis University
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Cardiology of Oklahoma
City
Tulsa
State/Province
Oklahoma
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study to Compare the Effects of Two Dosages of Tolvaptan in Congestive Heart Failure Patients
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