Multicenter, Randomized, Double-Blind, Placebo Controlled, Efficacy Study on the Effects of Tolvaptan on Left Ventricular Dilatation in Congestive Heart Failure Patients - Full Text View

Sponsor:	Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by:	Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:	NCT00043758

Purpose

The purpose of this study is to study the effects of tolvaptan on the size and function of the left heart chamber (ventricle) in patients with congestive heart failure (CHF)

Condition	Intervention	Phase
Congestive Heart Failure	Drug: Tolvaptan	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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:	170
Study Start Date:	July 2002
Estimated Study Completion Date:	July 2004

Eligibility

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

Criteria

History of congestive heart failure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043758

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Locations

United States, Arizona
Desert Cardiology of Tucson
Tucson, Arizona, United States, 85741
United States, Arkansas
Arkansas Heart
Little Rock, Arkansas, United States, 72211
United States, California
Northern California Medical Associates
Santa Rosa, California, United States, 95403
San Diego Cardiac Center
San Diego, California, United States, 92123
Cardiovascular Consultants Medical Group, Inc.
Walnut Creek, California, United States, 94598
United States, Colorado
University of Colorado
Denver, Colorado, United States, 80262
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06510
The Hoffman Heart Institute of CT/St. Francis Hospital
Hartford, Connecticut, United States, 06105
United States, Florida
Charlotte Heart Group
Port Charlotte, Florida, United States, 33952
Cardiovascular Research Center of South Florida
Miami, Florida, United States, 33173
Cardiology Associates of Fort Lauderdale
Fort Lauderdale, Florida, United States, 33308
The Heart and Vascular Institute of Florida
St. Petersburg, Florida, United States, 33701
United States, Georgia
Cardiovascular Associates of Augusta, PA
Augusta, Georgia, United States, 30901
Georgia Heart Specialists
Covington, Georgia, United States, 30014
United States, Illinois
Illinois Heart and Lung Associates, SC
Normal, Illinois, United States, 61761
United States, Indiana
The Care Group, LLC
Indianapolis, Indiana, United States, 46260
United States, Louisiana
Medical Research Institute
Slidell, Louisiana, United States, 70458
United States, Maine
Maine Cardiology Associates
Portland, Maine, United States, 04102
Androscoggin Cardiology Associates
Auburn, Maine, United States, 04210
United States, Massachusetts
Pentucket Medical Associates
Haverhill, Massachusetts, United States, 01839
Mystic Cardiology Associates, Inc.
Medford, Massachusetts, United States, 02155
United States, Michigan
John Dingell VA Medical Center
Detroit, Michigan, United States, 48201
Harper Hospital/Wayne State University
Detroit, Michigan, United States, 48201
United States, New York
South Bay Cardiovascular Associates
West Islip, New York, United States, 11795
St. Luke's-Roosevelt Hospital Center
New York, New York, United States, 10025
United States, Ohio
The Lindner Clinical Trial Center
Cincinnati, Ohio, United States, 45219
Midwest Cardiology Research Foundation
Columbus, Ohio, United States, 43202
North Ohio Research LTD.
Sandusky, Ohio, United States, 44870
North Ohio Research LTD
Lorraine, Ohio, United States, 44053
United States, Pennsylvania
Guthrie Clinic, LTD
Sayre, Pennsylvania, United States, 18840
Medical College of Pennsylvania
Philadelphia, Pennsylvania, United States, 19129
United States, Rhode Island
University Cardiology Foundation
Providence, Rhode Island, United States, 02905
Miriam Hospital
Providence, Rhode Island, United States, 02905
United States, South Carolina
Ralph H. Johnson VAMC
Charleston, South Carolina, United States, 29401
United States, Tennessee
Stern Cardiovascular Center
Memphis, Tennessee, United States, 38120
Canada, Manitoba
Health Sciences Center
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Newfoundland and Labrador
Health Sciences Center Memorial University of Newfoundland
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
London Health Sciences Center
London, Ontario, Canada, N6A 4G5
The Toronto Hospital
Toronto, Ontario, Canada, M5G 2C4
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8

Sponsors and Collaborators

Otsuka Pharmaceutical Development & Commercialization, Inc.

More Information

No publications provided by Otsuka Pharmaceutical Development & Commercialization, Inc.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Udelson JE, McGrew FA, Flores E, Ibrahim H, Katz S, Koshkarian G, O'Brien T, Kronenberg MW, Zimmer C, Orlandi C, Konstam MA. Multicenter, randomized, double-blind, placebo-controlled study on the effect of oral tolvaptan on left ventricular dilation and function in patients with heart failure and systolic dysfunction. J Am Coll Cardiol. 2007 Jun 5;49(22):2151-9. Epub 2007 May 18.

Study ID Numbers:	156-01-232
Study First Received:	August 13, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00043758 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 25, 2009