Transthyretin Amyloid Cardiomyopathy Clinical Trial

Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy

Summary

Open label study to evaluate tafamidis for the treatment of transthyretin cardiomyopathy

View Full Description

Full Description

Global Phase 3, open label long term extension safety study designed to obtain additional safety data for tafamidis meglumine 20 mg and 80 mg (or tafamidis 61 mg where available), and to continue to provide enrolled subjects with tafamidis for up to 60 months, or until subject has access to tafamidis for ATTR CM via prescription, whichever occurs first.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Cohort A: Completion of 30 months of study treatment on Pfizer Protocol B3461028

Cohort B: Patients in specific countries diagnosed with ATTR-CM who did not previously participate in Pfizer Study B3461028

Exclusion Criteria:

-Liver and/or heart transplant, or implanted cardiac mechanical assist device

Study is for people with:

Transthyretin Amyloid Cardiomyopathy

Phase:

Phase 3

Estimated Enrollment:

1733

Study ID:

NCT02791230

Recruitment Status:

Completed

Sponsor:

Pfizer

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There are 66 Locations for this study

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The Kirklin Clinic of UAB Hospital
Birmingham Alabama, 35233, United States
Cardiovascular Clinical Trials Unit (CCTU)
Birmingham Alabama, 35294, United States
University Hospital, University of Alabama at Birmingham
Birmingham Alabama, 35294, United States
California Heart Center
Beverly Hills California, 90211, United States
Cedars-Sinai Medical Care Foundation
Beverly Hills California, 90211, United States
Altman Clinical Translational Research Institute
La Jolla California, 92037, United States
University of California, San Diego
La Jolla California, 92037, United States
Cedars-Sinai Medical Center
Los Angeles California, 90048, United States
University of California, San Diego Medical Center - Hillcrest
San Diego California, 92103, United States
University of California, San Diego Medical Center - Hillcrest
San Diego California, 92103, United States
Center Adv Lab Medicine
San Diego California, 92121, United States
UCSF Ambulatory Care Center
San Francisco California, 94143, United States
University of California
San Francisco California, 94143, United States
UCSF Cardiovascular Care and Prevention Center
San Francisco California, 94158, United States
Stanford Hospital and Clinics Investigational Pharmacy
Stanford California, 94305, United States
Stanford University Hospital and Clinics
Stanford California, 94305, United States
Sylvester at Deerfield Beach
Deerfield Beach Florida, 33136, United States
Sylvester at Deerfield Beach
Deerfield Beach Florida, 33442, United States
University of Miami Hospital & Clinics/Sylvester Comprehensive Cancer Center
Miami Florida, 33136, United States
Northwestern Medical Group
Chicago Illinois, 60611, United States
Northwestern Memorial Hospital
Chicago Illinois, 60611, United States
Northwestern University
Chicago Illinois, 60611, United States
Advocate Christ Medical Center
Oak Lawn Illinois, 60453, United States
University of Maryland, Baltimore
Baltimore Maryland, 21201, United States
Johns Hopkins University
Baltimore Maryland, 21287, United States
Boston Medical Center Investigational Pharmacy
Boston Massachusetts, 02118, United States
Boston Medical Center
Boston Massachusetts, 02118, United States
Boston University Medical Center
Boston Massachusetts, 02118, United States
Michigan Medicine - Department of Pharmacy Services - Research Pharmacy
Ann Arbor Michigan, 48109, United States
Michigan Medicine,University of Michigan
Ann Arbor Michigan, 48109, United States
Mayo Clinic Hospital-Rochester
Rochester Minnesota, 55902, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Newark Beth Israel Medical Center
Newark New Jersey, 07112, United States
NYU Langone Health
New York New York, 10016, United States
Center for Advanced Cardiac Care
New York New York, 10032, United States
Columbia University Irving Medical Center
New York New York, 10032, United States
Columbia University Medical Center- Clinical Cardiovascular Research Laboratory for the Elderly
New York New York, 10034, United States
Duke University
Durham North Carolina, 27710, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
OHSU Center for Health and Healing
Portland Oregon, 97239, United States
OHSU Research Pharmacy Services
Portland Oregon, 97239, United States
Oregon Health & Science University
Portland Oregon, 97239, United States
Penn Presbyterian Medical Center
Philadelphia Pennsylvania, 19104, United States
Vanderbilt Univ. Med. Ctr
Nashville Tennessee, 37232, United States
Huntsman Cancer Hospital
Salt Lake City Utah, 84112, United States
University of Utah Hospitals & Clinics
Salt Lake City Utah, 84132, United States
University of Utah, Division of Cardiovascular Medicine
Salt Lake City Utah, 84132, United States
Instituto Cardiovascular de Buenos Aires
Ciudad Autónoma de Buenos Aires , C1428, Argentina
Westmead Hospital
Westmead New South Wales, 2145, Australia
Princess Alexandra Hospital
Woolloongabba Queensland, 4102, Australia
Eastern Health (Box Hill Hospital)
Box Hill Victoria, 3128, Australia
UZ Leuven
Leuven , 3000, Belgium
Hospital Universitário Clementino Fraga Filho (UFRJ)
Rio de Janeiro RJ, 21941, Brazil
University of Calgary/Foothills Medical Centre
Calgary Alberta, T2N 4, Canada
Gordon and Leslie Diamond Health Care Centre
Vancouver British Columbia, V5Z 1, Canada
Vancouver General Hospital
Vancouver British Columbia, V5Z 1, Canada
Toronto General Hospital
Toronto Ontario, M5G 2, Canada
University health network-Toronto General Hospital
Toronto Ontario, M5G 2, Canada
Montreal Heart Institute-Research Center
Montreal Quebec, H1T 1, Canada
Montreal Heart Institute
Montreal Quebec, H1T 1, Canada
Fakultni nemocnice u sv. Anny v Brne
Brno , 656 9, Czechia
Vseobecna fakultni nemocnice v Praze
Praha 2 , 128 0, Czechia
Institut klinicke a experimentalni mediciny
Praha 4 , 140 2, Czechia
Hopital de La Timone
Marseille CAN, 13005, France
CHU Henri Mondor
Creteil , 94010, France
Hôpital De La Timone
Marseille , 13385, France
Hopital Bichat
Paris , 75018, France
CHU de Rennes - Hopital Pontchaillou
Rennes , 35033, France
CHU de Rennes - Hôpital Pontchaillou
Rennes , 35033, France
CHU de Toulouse - Hôpital Rangueil
Toulouse , 31059, France
Medical University of Heidelberg
Heidelberg , 69120, Germany
Medizinisches Universitatsklinikum Heidelberg
Heidelberg , 69120, Germany
Universitätsklinikum Münster
Münster , 48149, Germany
Clinical Trial Pharmacy
Hong Kong , , Hong Kong
Queen Mary Hospital
Hong Kong , , Hong Kong
Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi
Bologna , 40138, Italy
Azienda Ospedaliera Universitaria Careggi
Firenze , 50134, Italy
Azienda Ospedaliero-Universitaria Careggi
Firenze , 50134, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia , 27100, Italy
Kurume University Hospital
Kurume-shi Fukuoka, 830-0, Japan
Kumamoto University Hospital
Kumamoto-city Kumamoto, 860-8, Japan
Shinshu University Hospital
Nagano , 390-8, Japan
University Medical Center Groningen
Groningen , 9713 , Netherlands
Unidad de Insuficiencia Cardiaca Avanzada y Transplante Cardiaco
A Coruna LA Coruna, 15006, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda Madrid, 28222, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña , 15006, Spain
Skellefteå Lasarett
Skellefteå , 931 8, Sweden
Akademiska Sjukhuset
Uppsala , 751 8, Sweden
Investigational Drug Services
Taipei , 100, Taiwan
National Taiwan University Hospital
Taipei , 100, Taiwan
Clinical Trial Pharmacy
Taipei , 112, Taiwan
Taipei Veterans General Hospital
Taipei , 112, Taiwan
Barts Health NHS Trust, St Bartholomew's Hospital
London , EC1A , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Transthyretin Amyloid Cardiomyopathy

Phase:

Phase 3

Estimated Enrollment:

1733

Study ID:

NCT02791230

Recruitment Status:

Completed

Sponsor:


Pfizer

How clear is this clinincal trial information?

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