EVEREST: Efficacy of Vasopressin Antagonism in hEart failuRE: Outcome Study With Tolvaptan

May 2, 2012 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

Protocol 156-03-236: Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long Term Efficacy and Safety of Oral Tolvaptan Tablets in Subjects Hospitalized With Worsening Congestive Heart Failure

The purpose of this study is to compare the effectiveness of tolvaptan or placebo in adults with worsening congestive heart failure (CHF).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Design: Multicenter, randomized, double-blind, placebo-controlled

Study Type

Interventional

Enrollment

3600

Phase

  • Phase 3

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

  • Argentina
      • Buenos Aires, Argentina
        • Fundacion Favaloro
      • Buenos Aires, Argentina
        • Clinica Constituyentes de Moron
      • Buenos Aires, Argentina
        • Clinica Modelo de Moron
      • Buenos Aires, Argentina
        • Hospital Argerich
      • Buenos Aires, Argentina
        • Hospital Churruca
      • Buenos Aires, Argentina
        • Hospital Eva Perón
      • Buenos Aires, Argentina
        • Hospital Nacional Dr. Alejandro Posadas
      • Capital Federal, Argentina
        • Hospital Italiano de Buenos Aires
      • Capital Federal, Argentina
        • Hospital de Clínicas
      • Capital Federal, Argentina
        • Hospital Fernandez
      • Capital Federal, Argentina
        • Hospital Privado Antartida
      • Capital Federal, Argentina
        • Hospital Ramos Mejia
      • Capital Federal, Argentina
        • Policlinica Bancaria
      • Capital Federal, Argentina
        • Sanatorio Municipal "Julio A. Mendez"
      • Cordoba, Argentina
        • Hospital Privado Centro Medico de Cordoba
      • Cordoba, Argentina
        • Hospital Italiano de Cordoba
      • Cordoba, Argentina
        • Hospital Allende
      • Cordoba, Argentina
        • Hospital Militar de Cordoba
      • Corrientes, Argentina
        • Instituto de Cardiologia J. F. Cabral
      • San Isidro, Argentina
        • Hospital Central de San Isidro
  • Belgium
      • Antwerpen, Belgium
        • AZ Middelheim
      • Bonheiden, Belgium
        • AZ Imelda Ziekenhuis
      • Namur, Belgium
        • Clinique St Elisabeth Place Louise
      • Yvoir, Belgium
        • Cliniques UCL Mont-Godinne
  • Brazil
      • Natal, Brazil, 59012-310
        • Hospital Universitário Onofre Lopes
      • Porto Alegre, Brazil, 90035-003
        • Hospital das Clinicas de Porto Alegre
      • Rio de Janeiro, Brazil, 20551-030
        • Hospital Universitário Pedro Ernesto
    • BA
      • Salvador, BA, Brazil, 40050-410
        • Hospital Santa Isabel da Santa Casa de Misericordia da Bahia
      • Salvador, BA, Brazil, 40140-060
        • Fundacao Bahiana de Cardiologia- Hospital Universitario Professor Edgard Santos
    • GO
      • Goiania, GO, Brazil, 74605-050
        • Hospital das Clínicas da Universidade Federal de Goiás
    • MG
      • Belo Horizonte, MG, Brazil, 30150-221
        • Santa Casa de Misericórdia de Belo Horizonte
      • Belo Horizonte, MG, Brazil, 30130-110
        • Hospital Governador Israel Pinheiro
    • PR
      • Curitiba, PR, Brazil, 80810-040
        • Hospital Nossa Senhora Das Gracas
      • Curitiba, PR, Brazil, 80730-150
        • Hospital Evangelico de Curitiba
    • RJ
      • Rio de Janeiro, RJ, Brazil, 20020-020
        • Santa Casa de Misericordia do Rio de Janeiro
    • RS
      • Porto Alegre, RS, Brazil, 90880-480
        • Hospital Mãe de Deus
      • Porto Alegre, RS, Brazil, 90020-090
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre
      • Porto Alegre, RS, Brazil, 90035-003
        • Hospital das Clinicas de Porto Alegre
      • Porto Alegre, RS, Brazil, 91350-200
        • Hospital Nossa Senhora da Conceica
    • SP
      • Campinas, SP, Brazil, 13059-740
        • Hospital e Maternidade Celso Pierro
      • Sao Jose de Rio Preto, SP, Brazil, 15090-020
        • Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto
      • Sao Jose do Rio Preto, SP, Brazil, 15015-210
        • IMC- Instituto de Molestias Cardiovasculares
      • Sao Paulo, SP, Brazil, 05403-000
        • Instituto do Coracao do Hospital das Clinicas- Faculdade de Medicina da Universidade de Sao Paulo
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T1Y6J4
        • Peter Loougheed Center
    • British Columbia
      • Surrey, British Columbia, Canada, V3V1Z2
        • Surrey Memorial Hospital
      • Victoria, British Columbia, Canada, V8R4R2
        • Victoria Heart Institute Foundation
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • St. Boniface General Hospital
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Health Sciences Center
    • Ontario
      • Brampton, Ontario, Canada, L6V1B4
        • Brampton Research Associates
      • Niagara Falls, Ontario, Canada, L2E6Y2
        • Greater Niagara General Hospital
      • Oshawa, Ontario, Canada, L1G2B9
        • Lakeridge Health Oshawa
      • Scarborough, Ontario, Canada, M1E5E9
        • Scarborough Cardiology Research
      • Scarborough, Ontario, Canada, M2S4V5
        • Cardiology Research Associates
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
      • Toronto, Ontario, Canada, M1P 2V5
        • The Scarborough Hospital
      • Toronto, Ontario, Canada, M5G 2C4
        • University Health Network, Toronto Western Hospital
    • Quebec
      • Fleurimond, Quebec, Canada, J1H 5N4
        • Centre Hospitalier de l'Université de Sherbrooke
      • Joliette, Quebec, Canada, J6E6J2
        • CHRDL
      • Longueuil, Quebec, Canada, J4M 1E1
        • Invascor Clinical Research
      • Montreal, Quebec, Canada, H3G 1A4
        • Montreal General Hospital
      • Montreal, Quebec, Canada, H1T1C8
        • Montreal Heart Institute
      • Montreal, Quebec, Canada, H3A1A1
        • Royal Victoria Hospital
      • Saint Jerome, Quebec, Canada, J7Z 5T3
        • Hotel-Dieu de Saint-Jerome
  • Czech Republic
      • Brno, Czech Republic
        • I. interni kardio-angiologicka klinika LF MU
      • Jablonec nad Nisou, Czech Republic
        • Interni oddeleni
      • Nachod, Czech Republic
        • Interni oddeleni
      • Pardubice, Czech Republic
        • Interni klinika, Oddeleni Interna I, Kardiologie
      • Pisek, Czech Republic
        • Interni oddeleni
      • Plzen-Lochotin, Czech Republic
        • I.Interni klinika
      • Praha, Czech Republic
        • I.Interni oddeleni
      • Praha, Czech Republic
        • II.Interni klinika
      • Praha, Czech Republic
        • Kardiologicka klinika
      • Praha, Czech Republic
        • Kardiologicke oddeleni
      • Praha, Czech Republic
        • Klinika kardiologie
      • Usti nad Labem, Czech Republic
        • Interni oddeleni
      • Zlin, Czech Republic
        • Interni klinika IPVZ
  • France
      • Arras, France
        • Centre Hospitalier Regional d'Arras-Service de Cardiologie
      • Avignon, France
        • Hopital General Henri Duffaut
      • Bar-le-Duc, France
        • Centre Hospitalier Jeanne d'Arc
      • Bron cedex, France
        • Hôpital Louis Pradel
      • Essey lès Nancy Cedex, France
        • Cabinet de Cardiologie et d'Explorations
      • Langres, France
        • Centre Hospitalier
      • Montpellier, France
        • CHU Montpellier
      • Nantes Cedex, France, 44093
        • Centre Hospitalo-Universitaire de Nantes-Service de Cardiologie
      • Nice, France
        • Hôpital Pasteur
      • Saint Denis, France
        • Centre Cardiologique du Nord
      • Toulouse, France, 31403
        • Groupe Hospitalier Rangueil-Larrey CHU
      • Vandoeuvre les Nancy, France
        • Centre Hospitalier Universitaire de Nancy-Brabois
  • Germany
      • Augsburg, Germany
        • Klinikum Augsburg
      • Bad Krozingen, Germany
        • Herzzentrum Bad Krozingen
      • Bad Neustadt-Saale, Germany
        • Herz- und Gefabklinik Bad Neustadt
      • Berlin, Germany
        • Vivantes Klinikum Neukoln
      • Essen, Germany
        • Universitätsklinik Essen
      • Essen, Germany
        • Akademisches Lehrkrankenhaus d. HGS Essen
      • Gottingen, Germany
        • Georg-August-Universität Göttingen
      • Greifswald, Germany
        • Universitatsklinikum der
      • Halle, Germany
        • Klinikum der Medizinischen Fakultat
      • Hamburg, Germany
        • Universitätsklinikum Eppendorf
      • Heidelberg, Germany
        • Universitatsklinikum Heidelberg
      • Heidelberg, Germany
        • Medizinische Universitätsklinik
      • Homburg/Saar, Germany
        • Universitatsklinikum des Saarland
      • Jena, Germany
        • Friedrich Schiller Universitat Jena
      • Koln, Germany
        • Klinikum der Universität zu Köln
      • Leipzig, Germany
        • University Leipzig
      • Munster, Germany
        • Universitätsklinikum Münster
      • Oeyenhausen, Germany
        • Herz- und Diabetes Zentrum Nordrhein-Westfalen
      • Regensburg, Germany
        • Universität Regensburg
      • Soest, Germany
        • Marienkrankenhaus Soest
      • Stuttgart, Germany
        • Robert-Bosch-Krankenhaus
  • Italy
      • Albano Laziale, Italy
        • Ospedale Civile S. Giuseppe
      • Cagliari, Italy
        • Azienda Ospedaliera S. Michele
      • Capri, Italy
        • Ospedale Civile
      • Cecina, Italy
        • Azienda USL n. 6 Ospedale Civile
      • Cortona, Italy
        • Poliambulatorio Valdichiana Ospedale di Cortona
      • Milano, Italy
        • Centro Cardiologico Monzino
      • Milano, Italy
        • Ospedale Nigaurda Ca Granda
      • Montescano, Italy
        • Fondazione Salvatore Maugeri
      • Palmero, Italy
        • Presidio Ospedaliero Villa Sofia
      • Parma, Italy
        • Ospedali Riunti
      • Pavia, Italy
        • IRCCS Policlinico S. Matteo
      • Pavia, Italy
        • IRCCS- Fondazione Salvatore Maugeri
      • Pozzuoli, Italy
        • Ospedale S. Maria delle Grazie
      • Sarzana, Italy
        • Ospedale S. Bartolomeo
      • Sassari, Italy
        • Ospedali Civile SS Annunziata
  • Netherlands
      • Amsterdam, Netherlands
        • Sint Lucas Andreas Ziekenhuis (loc. Lucas)
      • Apeldoorn, Netherlands
        • Gelre Ziekenhuis (location Juliana)
      • Blaricum, Netherlands
        • Ziekenhuis Gooi Noord
      • Den Bosch, Netherlands
        • Jeroen Bosch Ziekenhus (location Groot Ziekengasthius=GZG)
      • Den Haag, Netherlands
        • Medisch Centrum Haaglanden (location Westeinde)
      • Deventer, Netherlands
        • Deventer Ziekenhuis
      • Ede, Netherlands
        • Ziekenhuis Gelderse Vallei
      • Enschede, Netherlands
        • Medisch Spectrum Twente
      • Goes, Netherlands
        • Oosterschelde Ziekenhuizen
      • Groningen, Netherlands
        • Martini Ziekenhuis (Loc. Martini Paviljoen)
      • Heemstede, Netherlands
        • Spaarne Ziekenhuis
      • Hilversum, Netherlands
        • Ziekenhuis Hilversum
      • Nijmegen, Netherlands
        • Canisius-Wilhelmina Ziekenhuis
      • Zwolle, Netherlands
        • Isala Klinieken (Loc. Sophia)
  • Norway
      • Bergen, Norway
        • Hjerte med. Avd. Haukeland Universitets Sykehus
      • Bodo, Norway
        • Nordlandsykehuset
      • Nordbyhagen, Norway
        • Hjertemed.avd. Akershus Universitetssykenhus
      • Oslo, Norway
        • Diakonhjemmets sykehus Oslo
      • Skien, Norway
        • Med. Avd. Sykenhuset Telemark
      • Stavanger, Norway
        • Stavanger Helseforskning
  • Poland
      • Bydgoszcz, Poland
        • Oddzial Kardiologii
      • Krakow, Poland
        • Oddzial Kardiologii
      • Lodz, Poland
        • Oddzial Kardiologii
      • Olawa, Poland
        • Oddzial Chorob Wewnetrznych
      • Opole, Poland
        • Oddzial Kardiologiczny
      • Ostrowiec Swietokrzyski, Poland
        • Oddzial Kardiologii
      • Piotrków Trybunalski, Poland
        • Oddzial Kardiologiczny
      • Plock, Poland
        • Oddzial Kardiologiczny
      • Sieradz, Poland
        • Oddzial Kardiologii
      • Torun, Poland
        • Oddzial Kardiologii
      • Tychy, Poland
        • Katedra i Oddzial Kliniczny Kardiologii Slaskiej Akademii
      • Warszawa, Poland
        • I Klinika Choroby Wiencowej
      • Warszawa, Poland
        • Katedra i Klinika Chorab Wewnetrznych i Kardiologii
      • Wloclawek, Poland
        • Oddzial Kardiologii
  • Romania
      • Brasov, Romania
        • Spitalul Judetean Brasov, Sectia de Cardiologie
      • Bucharest, Romania
        • Institutul de Boli Cardiovasculare
      • Bucharest, Romania
        • Spitalul Caritas, Clinica Medicala
      • Bucharest, Romania
        • Spitalul de Urgenta Floreasca, Clinica de Cardiologie
      • Bucharest, Romania
        • Spitalul Universitar de Urgenta Bucuresti
      • Bucuresti, Romania
        • Spitalul Universitar de Urgenta
      • Cluj-Napoca, Romania
        • Institutul Inimii, Prof.N. Stancioiu
      • Craiova, Romania
        • Centrul de Cardiologie Craiova
      • Iasi, Romania
        • Spitalul Clinic Universitar ,,Sf. Spiridon"
      • Targu-Mures, Romania
        • Spitalul Clinic Judetean Mures
      • Timisoara, Romania
        • Institutul de Boli Cardiovasculare Timisoara
  • Russian Federation
      • Moscow, Russian Federation
        • Moscow State University of Medicine and Dentistry
      • Moscow, Russian Federation
        • Botkins Moscow City Hospital
      • Moscow, Russian Federation
        • Burdenko Main Military Clinical Hospital
      • Moscow, Russian Federation
        • Cardiology Research Center
      • Moscow, Russian Federation
        • Central Clinical Hospital Presidential
      • Moscow, Russian Federation
        • City Clinical Hospital 2
      • Moscow, Russian Federation
        • Institute of Physico-Chemical Medicine
      • Moscow, Russian Federation
        • Medical Center of General Management
      • Moscow, Russian Federation
        • Moscow Medical Academy
      • Moscow, Russian Federation
        • Moscow Regional Research Clinical Institute n.a. Vishnevsky
      • Moscow, Russian Federation
        • Moscow State University of Medicine and Dentistry - City Hospital #11
      • Moscow, Russian Federation
        • Moscow State University of Medicine and Dentistry - City Hospital #40
      • Moscow, Russian Federation
        • Russian State Medical University
      • Moscow, Russian Federation
        • Veterans Hospital #3
      • St. Petersburg, Russian Federation
        • Cardiology Research Institute of the Ministry of Health of the Russian Federation
      • St. Petersburg, Russian Federation
        • City Alexandrovsky Hospital, ICU Department
      • St. Petersburg, Russian Federation
        • City Hospital #31
      • St. Petersburg, Russian Federation
        • City Hospital 8
      • St. Petersburg, Russian Federation
        • Military Medical Academy
      • St. Petersburg, Russian Federation
        • St. Elisabeth City Hospital
      • St. Petersburg, Russian Federation
        • St. Petersburg Clinical Hospital of Russian Academy of Sciences
      • St. Petersburg, Russian Federation
        • St. Petersburg Dzanelidze State Scientific Research Institute for Emergency Medical Care
      • St. Petersburg, Russian Federation
        • St. Petersburg Medical Postgraduate Academy
      • St. Petersburg, Russian Federation
        • St. Petersburg State University
  • Spain
      • Almeria, Spain
        • Hospital de Torrecárdenas
      • Barcelona, Spain
        • Hospital Clinic y Provincial
      • Bilbao, Spain
        • Hospital De Cruces
      • Cordoba, Spain
        • Hospital Reina Sofia, in Cordoba
      • Madrid, Spain
        • Hospital Doce de Octubre
      • Madrid, Spain
        • Hospital Severo Ochoa
      • Tarragona, Spain
        • Hospital Universitari de Tarragona Joan XXIII
      • Valencia, Spain
        • Hospital General Universitario de Valencia
  • Sweden
      • Goteborg, Sweden
        • Medicinkliniken
      • Gothenburg, Sweden
        • Avd. for intermedicin
      • Linkoping, Sweden
        • Kardiologkliniken
      • Malmo, Sweden
        • Kardiologkliniken
      • Molndal, Sweden
        • Forskiningsenheten,
      • Stockholm, Sweden
        • Enheten for internmedicin, Karolinska Institutet
      • Stockholm, Sweden
        • Hjartkliniken, M84
      • Stockholm, Sweden
        • Kardiologkliniken
      • Umea, Sweden
        • Hjartcentrum,
      • Uppsala, Sweden
        • Cardiologkliniken, Avd 50F
  • Switzerland
      • Lugano, Switzerland
        • Cardiocentro Ticino
  • United Kingdom
      • Bradford, United Kingdom
        • Bradford Royal Infirmary
      • Cottingham, United Kingdom
        • Castle Hill Hospital
      • Leeds, United Kingdom
        • Leeds General Infirmary
      • Manchester, United Kingdom
        • Northern Manchester General Hospital
      • Scunthorpe, United Kingdom
        • Scunthorpe General Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
      • Huntsville, Alabama, United States, 35801
        • The Heart Center
      • Mobile, Alabama, United States, 36608
        • The Heart Group
    • Arizona
      • Gilbert, Arizona, United States, 85233
        • Phoenix Memorial Hospital
      • Phoenix, Arizona, United States, 85006
        • Arizona Heart Institute
      • Tucson, Arizona, United States, 85712
        • Saguaro Clinical Research
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
      • Little Rock, Arkansas, United States, 72205
        • Central Arkansas Veterans Healthcare Systems
    • California
      • Bakersfield, California, United States, 93301
        • Bakersfield Memorial Hospital
      • Bakersfield, California, United States, 93301
        • Central Cardiology Medical Center
      • Larkspur, California, United States, 94939
        • Cardiology Associates
      • Loma Linda, California, United States, 92354
        • Loma Linda University Medical Center
      • Los Angeles, California, United States, 90033
        • LAC/USC Medical Center
      • Los Angeles, California, United States, 90073
        • VA Medical Center- W. Los Angeles
      • Mission Viejo, California, United States, 92691
        • Mission Internal Medical Group
      • Redondo Beach, California, United States, 92077
        • ARI Clinical Trials
      • San Diego, California, United States, 92123
        • San Diego Cardiac Center
      • Santa Monica, California, United States, 90404
        • Pacific Heart Institute
      • Walnut Creek, California, United States, 94598
        • Cardiovascular Consultants Medical Group, Inc.
    • Colorado
      • Denver, Colorado, United States, 80262
        • University of Colorado
      • Denver, Colorado, United States, 80218
        • Aurora Denver Cardiology Associates
      • Fort Collins, Colorado, United States, 80528
        • Heart and Vascular Clinic of North Colorado
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Bakus Resesarch
    • Delaware
      • Newark, Delaware, United States, 19718
        • Christiana Care Health System
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • VA Medical Center
    • Florida
      • Atlantis, Florida, United States, 33462
        • Florida Cardiovascular Research
      • Fort Lauderdale, Florida, United States, 33308
        • Cardiology Associates of Fort Lauderdale
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • Jacksonville, Florida, United States, 32207
        • Jacksonville Heart Center
      • Jacksonville Beach, Florida, United States, 32250
        • Jacksonville Heart Center
      • Melbourne, Florida, United States, 32901
        • Melbourne Internal Medicine Assoc.
      • Miami, Florida, United States, 33136
        • University of Miami/ Jackson Memorial Hospital
      • Miami, Florida, United States, 33156
        • Miami Research and Education Foundation
      • Ocala, Florida, United States, 34480
        • Ocala Resarch Institute
      • Ormond Beach, Florida, United States, 32174
        • Cardiology Research Associates
      • Port Charlotte, Florida, United States, 33952
        • Charlotte Heart Group Research Center
      • Sarasota, Florida, United States, 34239
        • Cardiovascular Center of Sarasota
      • St. Petersburg, Florida, United States, 33701
        • The Heart And Vascular Institute Of Florida
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Cardiac Disease Specialists PC
      • Atlanta, Georgia, United States, 30342
        • Atlanta Heart and Vascular Research Group
      • Covington, Georgia, United States, 30014
        • Georgia Heart Specialists
    • Idaho
      • Boise, Idaho, United States, 83704
        • Idaho Cardiology Associates
      • Meridian, Idaho, United States, 83642
        • Idaho Cardiology Associates
    • Illinois
      • Bannockburn, Illinois, United States, 60015
        • North Shore Cardiologists
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Lombard, Illinois, United States, 60148
        • Midwest Heart Research Found.
      • Normal, Illinois, United States, 61761
        • Illinois Heart & Lung Associates
      • Peoria, Illinois, United States, 61603
        • Heart Care Midwest
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • The Care Group
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Mid America Cardiology
    • Kentucky
      • Louisville, Kentucky, United States, 40205
        • Cardiovascular Associates
      • Louisville, Kentucky, United States, 40207
        • Louisville Cardiology Medical Group
    • Louisiana
      • Chalmette, Louisiana, United States, 70043
        • The Louisiana Heart Center
      • Covington, Louisiana, United States, 70433
        • Northshore Medical Research
      • Houma, Louisiana, United States, 70360
        • Leonard J Chabert Medical Center
      • Shreveport, Louisiana, United States, 71103
        • Lousiana State University Health Sciences Center
      • Shreveport, Louisiana, United States, 71135
        • Cardiac Centers of LA, LLC
    • Maine
      • Auburn, Maine, United States, 04210
        • Androscoggin Cardiology Associates
      • Bangor, Maine, United States, 04401
        • Northeast Cardiology Associates
      • Portland, Maine, United States, 04102
        • Maine Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Midatlantic Cardiovascular Associates
      • Baltimore, Maryland, United States, 21229
        • Midatlantic Cardiovascular Associates
      • Baltimore, Maryland, United States, 21237
        • Midatlantic Cardiovascular Associates
      • Bel Air, Maryland, United States, 21014
        • Midatlantic Cardiovascular Associates
      • Easton, Maryland, United States, 21601
        • Shore Health System
      • Towson, Maryland, United States, 21204
        • Midatlantic Cardiovascular Associates
      • Towson, Maryland, United States, 21286
        • Heart Associates, P.A.
      • Westminster, Maryland, United States, 21157
        • Midatlantic Cardiovascular Associates
    • Massachusetts
      • Ayer, Massachusetts, United States, 01432
        • Primary Care Cardiology Research
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • John Dingell VA Medical Center
      • Petoskey, Michigan, United States, 49770
        • Nisus Research
      • Royal Oak, Michigan, United States, 48073-1026
        • William Beaumont Hospital
      • Saginaw, Michigan, United States, 48602
        • Covenant Medical Center
      • Troy, Michigan, United States, 48085
        • Beaumont Hospital
      • Ypsilanti, Michigan, United States, 48197
        • Michigan Heart
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute
      • Minneapolis, Minnesota, United States, 55416
        • Hennepin County Medical Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic, Division of Cardiology
      • St. Louis Park, Minnesota, United States, 55426
        • Park Nicollet Heart Center
      • St. Paul, Minnesota, United States, 55102
        • St. Paul Heart Clinic
      • St. Paul, Minnesota, United States, 55101
        • Regions Hospital Cardiology Research
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Cardiology Associates of North Mississippi
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Missouri Cardiovascular Specialists
      • Kansas City, Missouri, United States, 64128
        • VA Medical Center- Kansas City
      • St. Louis, Missouri, United States, 63110
        • St. Louis University
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Bryan LGH Heart Institute
      • Omaha, Nebraska, United States, 68122
        • Heart Consultants
    • New Hampshire
      • Manchester, New Hampshire, United States, 03102
        • New England Heart Institute
    • New Jersey
      • Morristown, New Jersey, United States, 07962-1956
        • Morristown Memorial Hospital
      • Newark, New Jersey, United States, 07112
        • Newark Beth Israel Medical Center
      • Newark, New Jersey, United States, 07103
        • University of Medicine and Dentistry of New Jersey
      • Paramus, New Jersey, United States, 07652
        • Garden State Cardiology
    • New York
      • Albany, New York, United States, 12212
        • Albany Associates in Cardiology
      • Johnson City, New York, United States, 13790
        • Cardiology Associates, P.C.
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • New York, New York, United States, 10032
        • New York Presbyterian Hospital
      • New York, New York, United States, 10011
        • St. Vincents Hospital and Medical Center
      • New York, New York, United States, 10019
        • St. Lukes-Roosevelt Hospital Centers
      • Roslyn, New York, United States, 11576
        • St. Francis Hospital
      • Syracuse, New York, United States, 13230
        • SUNY
      • West Islip, New York, United States, 11795
        • South Bay Cardiovascular Associates
      • Williamsville, New York, United States, 14221
        • Buffalo Cardiology and Pulmonary Associates
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Asheville Cardiology Associates
      • Burlington, North Carolina, United States, 27215
        • Alamance Regional Medical Center
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Mid Carolina Cardiology
      • Durham, North Carolina, United States, 27705
        • Durham VA Medical Center
      • Durham, North Carolina, United States, 27710
        • Duke Cardiology Research
      • Greenville, North Carolina, United States, 28735
        • Pitt County Memorial Hospital, The Heart Center
      • Hendersonville, North Carolina, United States, 28739
        • Hendersonville Cardiology
    • Ohio
      • Akron, Ohio, United States, 44307
        • Akron General Medical Center
      • Canton, Ohio, United States, 44718
        • Clinical Research Limited
      • Cincinnati, Ohio, United States, 45219
        • Sterling Research Group
      • Cincinnati, Ohio, United States, 45219
        • The Lindner Clinical Trial Center
      • Columbus, Ohio, United States, 43214
        • MidWest Cardiology Research Foundation
      • Dayton, Ohio, United States, 45414
        • The Dayton Heart Center
      • Fairview Park, Ohio, United States, 44126
        • Cleveland Cardiovascular Research
      • Lorain, Ohio, United States, 44052
        • North Ohio Research Limited
      • Sandusky, Ohio, United States, 44870
        • North Ohio Research Limited
      • Toledo, Ohio, United States, 43615
        • Northwest Ohio Cardiology Consultants
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Oklahoma Cardiovascular Research Group
      • Oklahoma City, Oklahoma, United States, 73112
        • Integris Heart Research Center
    • Oregon
      • Portland, Oregon, United States, 97230
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19146
        • Cardiology Consultants of Philadelphia
      • Pittsburgh, Pennsylvania, United States, 15224
        • The Western Pennsylvania Hospital
      • Sayre, Pennsylvania, United States, 18840
        • Guthrie Clinic, Ltd
      • Sellersville, Pennsylvania, United States, 18960
        • Buxmont Cardiology Associates, PC
      • West Reading, Pennsylvania, United States, 19611
        • Cardiology Associates of West Reading
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Rhode Island Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Medical University of South Carolina
      • Charleston, South Carolina, United States, 29401
        • Ralph H. Johnson VAMC
      • Columbia, South Carolina, United States, 29204
        • South Carolina Heart Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • The Chattanooga Heart Institute
      • Kingsport, Tennessee, United States, 37660
        • Cardiovascular Associates
      • Memphis, Tennessee, United States, 38120
        • Baptist Clinical Research Center
      • Memphis, Tennessee, United States, 38120
        • Stern Cardiovascular Center
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt Clinical Trials Center
      • Tullahoma, Tennessee, United States, 37388
        • The Cardiology Group
    • Texas
      • Austin, Texas, United States, 78705
        • Austin Cardiovascular Associates
      • Beaumont, Texas, United States, 77702
        • Southeast Texas Cardiology Associates
      • Dallas, Texas, United States, 75230
        • Cardiopulmonary Research Science and Technology Institute
      • Galveston, Texas, United States, 77555-0553
        • University of Texas Medical Branch
      • Lubbock, Texas, United States, 79410
        • Cardiology Associates Covenant Medical Group
      • McAllen, Texas, United States, 78503
        • McAllen Heart Clinic
      • San Antonio, Texas, United States, 78229-3900
        • University of Texas Health Science Center
      • San Antonio, Texas, United States, 78236
        • Wilford Hall Medical Center,
      • Temple, Texas, United States, 76508
        • Scott & White Clinic Division of Cardiology
    • Utah
      • Salt Lake City, Utah, United States, 84148
        • VA Salt Lake City Health Care System
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Medical Center
      • Fairfax, Virginia, United States, 22031
        • The Cardiovascular Group PC
      • Falls Church, Virginia, United States, 22042
        • Inova Institute of Research
      • Richmond, Virginia, United States, 23219
        • Medical College of Virginia
      • Richmond, Virginia, United States, 23225
        • Cardiovascular Associates of Virginia
      • Roanoke, Virginia, United States, 24014
        • Roanoke Heart Institute
    • Washington
      • Spokane, Washington, United States, 99204
        • Empire Health Services
      • Spokane, Washington, United States, 99204
        • Rockwood Clinic
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • CAMC Clinical Trials
    • Wisconsin
      • Elkhorn, Wisconsin, United States, 53121
        • Wisconsin Center for Clinical Research

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

Inclusion Criteria:

  • Age greater than or equal to 18 years.
  • Current hospitalization for chronic congestive heart failure with admission up to 48 hours prior to randomization. Chronic heart failure is defined as requiring treatment for a minimum of 30 days prior to hospitalization.

The subject must have signs of extracellular volume expansion, defined as two or more of the following: a) jugular venous distention; b) pitting edema (>1+); or c) dyspnea.

  • NYHA Class III or IV at the time of hospitalization.
  • Left Ventricular Ejection Fraction < = 40% within one year.

Exclusion Criteria

  • Women who will not adhere to the reproductive precautions as outlined in the Informed Consent form.
  • Positive urine pregnancy test.
  • Inability to provide written informed consent.
  • Cardiac surgery within 60 days of potential study enrollment, excluding percutaneous coronary interventions.
  • Planned revascularization procedures, electrophysiologic (EP) device implantation, cardiac mechanical support implantation, cardiac transplantation, or other cardiac surgery within 30 days following study enrollment.
  • Subjects who are on cardiac mechanical support.
  • History of bi-ventricular pacer placement within the last 60 days.
  • Co-morbid condition with an expected survival less than six months.
  • Subjects with acute ST segment elevation myocardial infarction at the time of hospitalization.
  • History of sustained ventricular tachycardia or ventricular fibrillation within 30 days, unless in the presence of an automatic implantable cardioverter defibrillator.
  • History of a cerebrovascular accident within the last 30 days.
  • Hemodynamically significant uncorrected primary cardiac valvular disease.
  • Hypertrophic cardiomyopathy (obstructive or non-obstructive).
  • CHF due to uncorrected thyroid disease, active myocarditis or known amyloid cardiomyopathy.
  • Subjects with progressive or episodic neurological disease such as multiple sclerosis or history of multiple strokes.
  • History of primary significant liver disease or acute hepatic failure, as defined by the investigator.
  • History of poorly controlled diabetes mellitus.
  • Morbid obesity, defined as > 159 kg (or 350 lbs) or BMI > 40.
  • Supine systolic arterial blood pressure < 90 mmHg.
  • Serum creatinine > 3.5 mg/dL or > 309.4 mmol/L.
  • Serum potassium > 5.5 mEq/L or > 5.5 mmol/L.
  • Hemoglobin < 9 g/dL or < 90 g/L.
  • History of hypersensitivity and/or idiosyncratic reaction to benzazepine derivatives (such as benazapril).
  • History of drug or medication abuse within the past year, or current alcohol abuse.
  • Inability to take oral medications.
  • Participation in another clinical drug or device trial within the past 30 days.
  • Previous participation in this or any other tolvaptan clinical trial.

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
  • 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

September 1, 2003

Primary Completion (ACTUAL)

July 1, 2006

Study Completion (ACTUAL)

July 1, 2006

Study Registration Dates

First Submitted

October 20, 2003

First Submitted That Met QC Criteria

October 20, 2003

First Posted (ESTIMATE)

October 21, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

May 3, 2012

Last Update Submitted That Met QC Criteria

May 2, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 156-03-236

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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