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

This study has been completed.
Sponsor:
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00043771
First received: August 13, 2002
Last updated: June 23, 2005
Last verified: September 2002
  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 2

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


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Central Cardiology Medical Clinic
Bakersfield, California, United States
University of California-San Diego
San Diego, California, United States
United States, Florida
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
University of Missouri-Kansas City School of Medicine
Kansas City, Missouri, United States
Saint Louis University
St. Louis, 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

ClinicalTrials.gov Identifier: NCT00043771     History of Changes
Other Study ID Numbers: 156-01-231
Study First Received: August 13, 2002
Last Updated: June 23, 2005
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 September 18, 2014