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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

Primary Purpose

Congestive Heart Failure

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tolvaptan
Sponsored by
Otsuka Pharmaceutical Development & Commercialization, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring CHF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

History of congestive heart failure

Sites / Locations

  • Desert Cardiology of Tucson
  • Arkansas Heart
  • San Diego Cardiac Center
  • Northern California Medical Associates
  • Cardiovascular Consultants Medical Group, Inc.
  • University of Colorado
  • The Hoffman Heart Institute of CT/St. Francis Hospital
  • Yale University
  • Cardiology Associates of Fort Lauderdale
  • Cardiovascular Research Center of South Florida
  • Charlotte Heart Group
  • The Heart and Vascular Institute of Florida
  • Cardiovascular Associates of Augusta, PA
  • Georgia Heart Specialists
  • Illinois Heart and Lung Associates, SC
  • The Care Group, LLC
  • Medical Research Institute
  • Androscoggin Cardiology Associates
  • Maine Cardiology Associates
  • Pentucket Medical Associates
  • Mystic Cardiology Associates, Inc.
  • Harper Hospital/Wayne State University
  • John Dingell VA Medical Center
  • St. Luke's-Roosevelt Hospital Center
  • South Bay Cardiovascular Associates
  • The Lindner Clinical Trial Center
  • Midwest Cardiology Research Foundation
  • North Ohio Research LTD
  • North Ohio Research LTD.
  • Medical College of Pennsylvania
  • Guthrie Clinic, LTD
  • Miriam Hospital
  • University Cardiology Foundation
  • Ralph H. Johnson VAMC
  • Stern Cardiovascular Center
  • Health Sciences Center
  • Health Sciences Center Memorial University of Newfoundland
  • London Health Sciences Center
  • St. Michael's Hospital
  • The Toronto Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 13, 2002
Last Updated
June 23, 2005
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00043758
Brief Title
Multicenter, Randomized, Double-Blind, Placebo Controlled, Efficacy Study on the Effects of Tolvaptan on Left Ventricular Dilatation in Congestive Heart Failure Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2005
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.

4. Oversight

5. Study Description

Brief Summary
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
CHF

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
170 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tolvaptan

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
History of congestive heart failure
Facility Information:
Facility Name
Desert Cardiology of Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Arkansas Heart
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
San Diego Cardiac Center
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Northern California Medical Associates
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Cardiovascular Consultants Medical Group, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
University of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
The Hoffman Heart Institute of CT/St. Francis Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Cardiology Associates of Fort Lauderdale
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Cardiovascular Research Center of South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Charlotte Heart Group
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
The Heart and Vascular Institute of Florida
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Cardiovascular Associates of Augusta, PA
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
Georgia Heart Specialists
City
Covington
State/Province
Georgia
ZIP/Postal Code
30014
Country
United States
Facility Name
Illinois Heart and Lung Associates, SC
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
The Care Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Medical Research Institute
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70458
Country
United States
Facility Name
Androscoggin Cardiology Associates
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
Maine Cardiology Associates
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Pentucket Medical Associates
City
Haverhill
State/Province
Massachusetts
ZIP/Postal Code
01839
Country
United States
Facility Name
Mystic Cardiology Associates, Inc.
City
Medford
State/Province
Massachusetts
ZIP/Postal Code
02155
Country
United States
Facility Name
Harper Hospital/Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
John Dingell VA Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
St. Luke's-Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
South Bay Cardiovascular Associates
City
West Islip
State/Province
New York
ZIP/Postal Code
11795
Country
United States
Facility Name
The Lindner Clinical Trial Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Midwest Cardiology Research Foundation
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43202
Country
United States
Facility Name
North Ohio Research LTD
City
Lorraine
State/Province
Ohio
ZIP/Postal Code
44053
Country
United States
Facility Name
North Ohio Research LTD.
City
Sandusky
State/Province
Ohio
ZIP/Postal Code
44870
Country
United States
Facility Name
Medical College of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19129
Country
United States
Facility Name
Guthrie Clinic, LTD
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
University Cardiology Foundation
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Ralph H. Johnson VAMC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
Stern Cardiovascular Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Health Sciences Center
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
Health Sciences Center Memorial University of Newfoundland
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
London Health Sciences Center
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
The Toronto Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
17543634
Citation
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. doi: 10.1016/j.jacc.2007.01.091. Epub 2007 May 18.
Results Reference
derived

Learn more about this trial

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

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