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NCT00043771 Clinical Trial

Study to Compare the Effects of Two Dosages of Tolvaptan in Congestive Heart Failure Patients

Congestive Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00043771
Other study ID # 156-01-231
Secondary ID
Status Completed
Phase Phase 2
First received August 13, 2002
Last updated June 23, 2005
Start date May 2002
Est. completion date September 2002

Study information
Verified date September 2002
Source Otsuka Pharmaceutical Development & Commercialization, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date September 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility History of CHF

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Tolvaptan

Locations
Country Name City State
United States Androscoggin Cardiology Associates Auburn Maine
United States Central Cardiology Medical Clinic Bakersfield California
United States Medical University of South Carolina Charleston South Carolina
United States University of Missouri-Kansas City School of Medicine Kansas City Missouri
United States University of Miami/Jackson Memorial Hospital Miami Florida
United States University of California-San Diego San Diego California
United States Medical Research Institute Slidell Louisiana
United States Saint Louis University St. Louis Missouri
United States Cardiology of Oklahoma Tulsa Oklahoma

Sponsors (1)
Lead Sponsor Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.

Country where clinical trial is conducted

United States, 

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