Clinical trial NCT00043758: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Congestive Heart Failure
Keywords: CHF
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2002-08-14
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: History of congestive heart failure

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Desert Cardiology of Tucson
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Heart
state: Arkansas
city: San Diego
country: United States
facility: San Diego Cardiac Center
state: California
city: Santa Rosa
country: United States
facility: Northern California Medical Associates
state: California
city: Walnut Creek
country: United States
facility: Cardiovascular Consultants Medical Group, Inc.
state: California
city: Denver
country: United States
facility: University of Colorado
state: Colorado
city: Hartford
country: United States
facility: The Hoffman Heart Institute of CT/St. Francis Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Cardiology Associates of Fort Lauderdale
state: Florida
city: Miami
country: United States
facility: Cardiovascular Research Center of South Florida
state: Florida
city: Port Charlotte
country: United States
facility: Charlotte Heart Group
state: Florida
city: St. Petersburg
country: United States
facility: The Heart and Vascular Institute of Florida
state: Florida
city: Augusta
country: United States
facility: Cardiovascular Associates of Augusta, PA
state: Georgia
city: Covington
country: United States
facility: Georgia Heart Specialists
state: Georgia
city: Normal
country: United States
facility: Illinois Heart and Lung Associates, SC
state: Illinois
city: Indianapolis
country: United States
facility: The Care Group, LLC
state: Indiana
city: Slidell
country: United States
facility: Medical Research Institute
state: Louisiana
city: Auburn
country: United States
facility: Androscoggin Cardiology Associates
state: Maine
city: Portland
country: United States
facility: Maine Cardiology Associates
state: Maine
city: Haverhill
country: United States
facility: Pentucket Medical Associates
state: Massachusetts
city: Medford
country: United States
facility: Mystic Cardiology Associates, Inc.
state: Massachusetts
city: Detroit
country: United States
facility: Harper Hospital/Wayne State University
state: Michigan
city: Detroit
country: United States
facility: John Dingell VA Medical Center
state: Michigan
city: New York
country: United States
facility: St. Luke's-Roosevelt Hospital Center
state: New York
city: West Islip
country: United States
facility: South Bay Cardiovascular Associates
state: New York
city: Cincinnati
country: United States
facility: The Lindner Clinical Trial Center
state: Ohio
city: Columbus
country: United States
facility: Midwest Cardiology Research Foundation
state: Ohio
city: Lorraine
country: United States
facility: North Ohio Research LTD
state: Ohio
city: Sandusky
country: United States
facility: North Ohio Research LTD.
state: Ohio
city: Philadelphia
country: United States
facility: Medical College of Pennsylvania
state: Pennsylvania
city: Sayre
country: United States
facility: Guthrie Clinic, LTD
state: Pennsylvania
city: Providence
country: United States
facility: Miriam Hospital
state: Rhode Island
city: Providence
country: United States
facility: University Cardiology Foundation
state: Rhode Island
city: Charleston
country: United States
facility: Ralph H. Johnson VAMC
state: South Carolina
city: Memphis
country: United States
facility: Stern Cardiovascular Center
state: Tennessee
city: Winnipeg
country: Canada
facility: Health Sciences Center
state: Manitoba
city: St. John's
country: Canada
facility: Health Sciences Center Memorial University of Newfoundland
state: Newfoundland and Labrador
city: London
country: Canada
facility: London Health Sciences Center
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: The Toronto Hospital
state: Ontario
Study officials:
References:
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.