Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy

PHASE3CompletedINTERVENTIONAL
Enrollment

441

Participants

Timeline

Start Date

December 9, 2013

Primary Completion Date

February 7, 2018

Study Completion Date

February 7, 2018

Conditions
Transthyretin (TTR) Amyloid Cardiomyopathy
Interventions
DRUG

Tafamidis

Tafamidis 20 mg in soft gel capsules administered once a day for 30 months

DRUG

Tafamidis

Tafamidis 80 mg in soft gel capsules administered once a day for 30 months

DRUG

Placebo

Placebo in soft gel capsules administered once a day for 30 months

Trial Locations (80)

3000

Universitaire Ziekenhuizen Leuven, Leuven

10016

New York University Hospitals, New York

10029

Icahn School of Medicine at Mount Sinai and Mount Sinai Hospital, New York

Mount Sinai Doctors Faculty Practice, New York

The Mount Sinai Hospital Department of Pharmacy, New York

10032

Columbia University Medical Center Research Pharmacy, New York

10034

Columbia University Medical Center/Clinical Cardiovascular Research Laboratory for the Elderly, New York

12808

Vseobecna fakultni nemocnice v Praze, Nemocnicni lekarna, Prague

15006

Hospital Universitario A Coruna, A Coruña

19104

Penn Presbyterian Medical Center, Philadelphia

21201

University of Maryland, School of Medicine, Baltimore

21287

Johns Hopkins University, Baltimore

The Johns Hopkins Hospital IDS Pharmacy, Baltimore

23298

VCU Medical Center - Ambulatory Care Clinic, Richmond

VCU Medical Center - Main Hospital, Richmond

25123

Unita Operativa di Cardiologia, Brescia

27100

Centro per lo Studio e la Cura Delle Amiloidosi Sistemiche - Fondazione IRCCS Policlinico S. Matteo, Pavia

27710

Duke University Health System, Durham

28222

Hospital Universitario Puerta De Hierro - Majadahonda, Majadahonda

30120

Hospital Clinico Universitario Virgen de la Arrixaca, El Palmar

33136

University of Miami Hospital & Clinics, Miami

33442

UM Sylvester at Deerfield Beach, Deerfield Beach

35249

The Kirklin Clinic, Birmingham

UAB Hospital Department of Pharmacy IDS, Birmingham

University Hospital, University of Alabama at Birmingham, Birmingham

37232

Vanderbilt University Medical Center, Nashville

40138

U.O. Cardiologia- Prof. Rapezzi, Bologna

44195

Cleveland Clinic, Cleveland

48109

Michigan Medicine,University of Michigan, Ann Arbor

48149

Universitaetsklinikum Muenster, Münster

50134

S.O.D. Cardiologia Generale 1 - D.A.I. del Cuore e dei Vasi, Florence

55905

Mayo Clinic Pharmacy Research Supp, Rochester

Mayo Clinic, Rochester

60453

Advocate Christ Medical Centre, Oak Lawn

60611

Northwestern Medical Group, Chicago

Northwestern Memorial Hospital, Chicago

69120

Medical University of Heidelberg, Heidelberg

70121

Ochsner Medical Center, New Orleans

77030

Houston Methodist Hospital, Houston

84132

University of Utah,Health Sciences Center, Salt Lake City

85054

Mayo Clinic Arizona - Mayo Clinic Speciality Building, Phoenix

Mayo Clinic Hospital, Phoenix

85259

Mayo Clinic Arizona - Mayo Clinic Building, Scottsdale

90048

Cedars-Sinai Medical Center, Investigational Drug Pharmacy Services, Los Angeles

Cedars-Sinai Medical Center, Los Angeles

90211

Cedars-Sinai Medical Care Foundation, Los Angeles

92037

Altman Clinical Translational Research Institute, La Jolla

UCSD Sulpizio Cardiovascular Center, La Jolla

92140

Hopital Antoine Beclere, Clamart

93186

Medicin-Geriatrik kliniken-Skelleftea lasarett, Skellefteå

94010

CHU Henri Mondor, Créteil

94143

UCSF Cardiovascular Care and Prevention Center, San Francisco

94305

Stanford University Hospital and Clinics, Stanford

97239

OHSU Center for Health and Healing, Portland

OHSU Research Pharmacy Services, Portland

Oregon Health and Science University (OHSU), Portland

98101

Virginia Mason Medical Center, Seattle

8608556

Kumamoto University Hospital, Kumamoto

92037-0620

UCSD Clinical and Translational Research Institute, Investigational Drug Service, La Jolla

92037-0990

Altman Clinical Translational Research institute, La Jolla

02118

Boston Medical Center - Cardiovascular Center, Outpatient Clinic, Boston

Boston Medical Center Investigational Pharmacy Services, Boston

Boston Medical Center, Boston

Boston University Medical Center General Clinical Research Unit, Boston

07112

Newark Beth Israel Medical Center, Newark

21941-913

Unidade de Pesquisa Clinica / Hospital Universitario Clementino Fraga Filho / UFRJ, Rio de Janeiro

T2N 4Z6

University of Calgary/Foothills Medical Centre, Calgary

M5G 2N2

Toronto General Hospital, Toronto

656 91

Fakultni nemocnice u sv. Anny, Nemocnicni lekarna, Brno

Nemocnice u sv. Anny v Brne, Brno

128 08

Vseobecna fakultni nemocnice v Praze, Prague

140 21

IKEM, Ustavni lekarna, Prague

IKEM, Prague

830-0011

Kurume University Hospital, Kurume-shi

390-8621

Shinshu University Hospital, Nagano

9713 GZ

University Medical Center Groningen, Groningen

751 85

Sjukhusvägen, Akademiska sjukhuset, Uppsala

EC1A 7BE

St Bartholomew's Hospital-Barts Health NHS Trust, London

SW17 0QT

St. George's Hospital (St George's Healthcare NHS Trust), London

SW17 0RE

St. George's University of London, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY