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

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ClinicalTrials.gov Identifier: NCT00043771
Recruitment Status : Completed
First Posted : August 14, 2002
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.

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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Drug: Tolvaptan Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
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
Study Start Date : May 2002
Study Completion Date : September 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Tolvaptan
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
History of CHF

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.

ClinicalTrials.gov Identifier: NCT00043771     History of Changes
Other Study ID Numbers: 156-01-231
First Posted: August 14, 2002    Key Record Dates
Last Update Posted: June 24, 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