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

June 23, 2005 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.
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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

170

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

History of congestive heart failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Study Completion

July 1, 2004

Study Registration Dates

First Submitted

August 13, 2002

First Submitted That Met QC Criteria

August 13, 2002

First Posted (Estimate)

August 14, 2002

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

June 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 156-01-232

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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