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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00043771
First Posted: August 14, 2002
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.
  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
Intervention Model: Parallel Assignment
Masking: Double
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
History of CHF
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00043771     History of Changes
Other Study ID Numbers: 156-01-231
First Submitted: August 13, 2002
First Posted: August 14, 2002
Last Update Posted: December 9, 2005
Last Verified: September 2002

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Tolvaptan
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs