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

NCT ID: NCT00043758

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2004-07-31

Brief Summary

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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)

Detailed Description

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Conditions

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Congestive Heart Failure

Keywords

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CHF

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Tolvaptan

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

History of congestive heart failure
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role lead

Locations

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Desert Cardiology of Tucson

Tucson, Arizona, United States

Site Status

Arkansas Heart

Little Rock, Arkansas, United States

Site Status

San Diego Cardiac Center

San Diego, California, United States

Site Status

Northern California Medical Associates

Santa Rosa, California, United States

Site Status

Cardiovascular Consultants Medical Group, Inc.

Walnut Creek, California, United States

Site Status

University of Colorado

Denver, Colorado, United States

Site Status

The Hoffman Heart Institute of CT/St. Francis Hospital

Hartford, Connecticut, United States

Site Status

Yale University

New Haven, Connecticut, United States

Site Status

Cardiology Associates of Fort Lauderdale

Fort Lauderdale, Florida, United States

Site Status

Cardiovascular Research Center of South Florida

Miami, Florida, United States

Site Status

Charlotte Heart Group

Port Charlotte, Florida, United States

Site Status

The Heart and Vascular Institute of Florida

St. Petersburg, Florida, United States

Site Status

Cardiovascular Associates of Augusta, PA

Augusta, Georgia, United States

Site Status

Georgia Heart Specialists

Covington, Georgia, United States

Site Status

Illinois Heart and Lung Associates, SC

Normal, Illinois, United States

Site Status

The Care Group, LLC

Indianapolis, Indiana, United States

Site Status

Medical Research Institute

Slidell, Louisiana, United States

Site Status

Androscoggin Cardiology Associates

Auburn, Maine, United States

Site Status

Maine Cardiology Associates

Portland, Maine, United States

Site Status

Pentucket Medical Associates

Haverhill, Massachusetts, United States

Site Status

Mystic Cardiology Associates, Inc.

Medford, Massachusetts, United States

Site Status

Harper Hospital/Wayne State University

Detroit, Michigan, United States

Site Status

John Dingell VA Medical Center

Detroit, Michigan, United States

Site Status

St. Luke's-Roosevelt Hospital Center

New York, New York, United States

Site Status

South Bay Cardiovascular Associates

West Islip, New York, United States

Site Status

The Lindner Clinical Trial Center

Cincinnati, Ohio, United States

Site Status

Midwest Cardiology Research Foundation

Columbus, Ohio, United States

Site Status

North Ohio Research LTD

Lorraine, Ohio, United States

Site Status

North Ohio Research LTD.

Sandusky, Ohio, United States

Site Status

Medical College of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Guthrie Clinic, LTD

Sayre, Pennsylvania, United States

Site Status

Miriam Hospital

Providence, Rhode Island, United States

Site Status

University Cardiology Foundation

Providence, Rhode Island, United States

Site Status

Ralph H. Johnson VAMC

Charleston, South Carolina, United States

Site Status

Stern Cardiovascular Center

Memphis, Tennessee, United States

Site Status

Health Sciences Center

Winnipeg, Manitoba, Canada

Site Status

Health Sciences Center Memorial University of Newfoundland

St. John's, Newfoundland and Labrador, Canada

Site Status

London Health Sciences Center

London, Ontario, Canada

Site Status

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status

The Toronto Hospital

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

References

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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.

Reference Type DERIVED
PMID: 17543634 (View on PubMed)

Other Identifiers

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156-01-232

Identifier Type: -

Identifier Source: org_study_id