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

This study is currently recruiting patients.

Sponsored by: Otsuka Maryland Research Institute
Information provided by: Otsuka Maryland Research Institute

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 Treatment or Intervention Phase
Congestive Heart Failure
 Drug: Tolvaptan
Phase II

MedlinePlus related topics:  Heart Failure

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

Further Study Details: 

Expected Total Enrollment:  170

Study start: July 2002;  Study completion: December 2002

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

History of congestive heart failure

Location and Contact Information

Patty Wedge      617-636-5068 

Arizona
      Desert Cardiology of Tucson, Tucson,  Arizona,  85741,  United States; Recruiting
Gregory Koshkarian, MD,  Principal Investigator

Arkansas
      Arkansas Heart, Little Rock,  Arkansas,  72211,  United States; Not yet recruiting
Steven Hutchins, MD,  Principal Investigator

California
      Northern California Medical Associates, Santa Rosa,  California,  95403,  United States; Recruiting
Patrick Coleman, MD,  Principal Investigator

      San Diego Cardiac Center, San Diego,  California,  92123,  United States; Recruiting
John Gordon, MD,  Principal Investigator

      Cardiovascular Consultants Medical Group, Inc., Walnut Creek,  California,  94598,  United States; Not yet recruiting
Mark Nathan, MD,  Principal Investigator

Colorado
      University of Colorado, Denver,  Colorado,  80262,  United States; Not yet recruiting
JoAnn Lindenfeld, MD,  Principal Investigator

Connecticut
      Yale University, New Haven,  Connecticut,  06510,  United States; Not yet recruiting
Stewart Katz, MD,  Principal Investigator

      The Hoffman Heart Institute of CT/St. Francis Hospital, Hartford,  Connecticut,  06105,  United States; Recruiting
Richard Soucier, MD,  Principal Investigator

Florida
      Charlotte Heart Group, Port Charlotte,  Florida,  33952,  United States; Recruiting
Terrence Connelly, MD,  Principal Investigator

      Cardiovascular Research Center of South Florida, Miami,  Florida,  33173,  United States; Recruiting
Alvaro Flores, MD,  Principal Investigator

      Cardiology Associates of Fort Lauderdale, Fort Lauderdale,  Florida,  33308,  United States; Recruiting
Pablo Guzman, MD,  Principal Investigator

      The Heart and Vascular Institute of Florida, St. Petersburg,  Florida,  33701,  United States; Recruiting
Gregg Schuyler, MD,  Principal Investigator

Georgia
      Cardiovascular Associates of Augusta, PA, Augusta,  Georgia,  30901,  United States; Not yet recruiting
Arthur B Chandler, MD,  Principal Investigator

      Georgia Heart Specialists, Covington,  Georgia,  30014,  United States; Recruiting
Enrique Flores, MD,  Principal Investigator

Illinois
      Illinois Heart and Lung Associates, SC, Normal,  Illinois,  61761,  United States; Not yet recruiting
Robert Braadstad, MD,  Principal Investigator

Indiana
      The Care Group, LLC, Indianapolis,  Indiana,  46260,  United States; Recruiting
Mary Walsh, MD,  Principal Investigator

Louisiana
      Medical Research Institute, Slidell,  Louisiana,  70458,  United States; Not yet recruiting
Vasanth Bethala, MD,  Principal Investigator

Maine
      Maine Cardiology Associates, Portland,  Maine,  04102,  United States; Not yet recruiting
Joseph Wight, MD,  Principal Investigator

      Androscoggin Cardiology Associates, Auburn,  Maine,  04210,  United States; Recruiting
Robert Weiss, MD,  Principal Investigator

Massachusetts
      Pentucket Medical Associates, Haverhill,  Massachusetts,  01839,  United States; Recruiting
Seth Bilazarian, MD,  Principal Investigator

      Mystic Cardiology Associates, Inc., Medford,  Massachusetts,  02155,  United States; Not yet recruiting
Laurence Conway, MD,  Principal Investigator

Michigan
      John Dingell VA Medical Center, Detroit,  Michigan,  48201,  United States; Not yet recruiting
Edouard Daher, MD,  Principal Investigator

      Harper Hospital/Wayne State University, Detroit,  Michigan,  48201,  United States; Not yet recruiting
Marvin Kronenberg, MD,  Principal Investigator

New York
      South Bay Cardiovascular Associates, West Islip,  New York,  11795,  United States; Not yet recruiting
Larry Altschul, MD,  Principal Investigator

      St. Luke's-Roosevelt Hospital Center, New York,  New York,  10025,  United States; Not yet recruiting
Jonathan Sackner-Bernstein, MD,  Principal Investigator

Ohio
      The Lindner Clinical Trial Center, Cincinnati,  Ohio,  45219,  United States; Recruiting
Eugene Chung, MD,  Principal Investigator

      Midwest Cardiology Research Foundation, Columbus,  Ohio,  43202,  United States; Recruiting
Gary Haas, MD,  Principal Investigator

      North Ohio Research LTD., Sandusky,  Ohio,  44870,  United States; Recruiting
Hassan Ibrahim, MD,  Principal Investigator

      North Ohio Research LTD, Lorraine,  Ohio,  44053,  United States; Recruiting
David Joyce, MD,  Principal Investigator

Pennsylvania
      Guthrie Clinic, LTD, Sayre,  Pennsylvania,  18840,  United States; Not yet recruiting
Dwight Stapleton, MD,  Principal Investigator

      Medical College of Pennsylvania, Philadelphia,  Pennsylvania,  19129,  United States; Not yet recruiting
William Van Decker, MD,  Principal Investigator

Rhode Island
      University Cardiology Foundation, Providence,  Rhode Island,  02905,  United States; Not yet recruiting
Daniel Levine, MD,  Principal Investigator

      Miriam Hospital, Providence,  Rhode Island,  02905,  United States; Not yet recruiting
Ara Sadaniantz, MD,  Principal Investigator

South Carolina
      Ralph H. Johnson VAMC, Charleston,  South Carolina,  29401,  United States; Not yet recruiting
Terrence O'Brien, MD,  Principal Investigator

Tennessee
      Stern Cardiovascular Center, Memphis,  Tennessee,  38120,  United States; Recruiting
Frank McGrew, MD,  Principal Investigator

Canada, Manitoba
      Health Sciences Center, Winnipeg,  Manitoba,  R3A 1R9,  Canada; Not yet recruiting
Eduardo Azevedo, MD,  Principal Investigator

Canada, Newfoundland and Labrador
      Health Sciences Center Memorial University of Newfoundland, St. John's,  Newfoundland and Labrador,  A1B 3V6,  Canada; Not yet recruiting
Bruce Sussex, MD,  Principal Investigator

Canada, Ontario
      London Health Sciences Center, London,  Ontario,  N6A 4G5,  Canada; Not yet recruiting
Malcolm Arnold, MD,  Principal Investigator

      The Toronto Hospital, Toronto,  Ontario,  M5G 2C4,  Canada; Not yet recruiting
Peter Liu, MD,  Principal Investigator

      St. Michael's Hospital, Toronto,  Ontario,  M5B 1W8,  Canada; Not yet recruiting
Gordon Moe, MD,  Principal Investigator

More Information

Study ID Numbers:  156-01-232
Record last reviewed:  August 2002
Record first received:  August 13, 2002
ClinicalTrials.gov Identifier:  NCT00043758
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10
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