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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
Otsuka Pharmaceutical Development & Commercialization, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring CHF

Eligibility Criteria

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

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

First Posted
August 13, 2002
Last Updated
June 23, 2005
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
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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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