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

This study has been completed.

First Received: August 13, 2002 Last Updated: June 23, 2005 History of Changes

Sponsor:	Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by:	Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:	NCT00043771

Purpose

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.

Condition	Intervention	Phase
Congestive Heart Failure	Drug: Tolvaptan	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study
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

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: Tolvaptan

U.S. FDA Resources

Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Estimated Enrollment:	40
Study Start Date:	May 2002
Estimated Study Completion Date:	September 2002

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

History of CHF

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043771

Locations

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

Sponsors and Collaborators

Otsuka Pharmaceutical Development & Commercialization, Inc.

More Information

No publications provided

Study ID Numbers:	156-01-231
Study First Received:	August 13, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00043771 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

CHF

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 09, 2009