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Trial record 2 of 26 for:    tafamidis

Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy

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ClinicalTrials.gov Identifier: NCT02791230
Recruitment Status : Recruiting
First Posted : June 6, 2016
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment Phase
Transthyretin (TTR) Amyloid Cardiomyopathy Drug: Tafamidis Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1400 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A PHASE 3 MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY OF DAILY ORAL DOSING OF TAFAMIDIS MEGLUMINE (PF-06291826-83) 20 MG OR 80 MG [OR TAFAMIDIS (PF-06291826-00) 61 MG] IN SUBJECTS DIAGNOSED WITH TRANSTHYRETIN CARDIOMYOPATHY (ATTR-CM)
Actual Study Start Date : June 13, 2016
Estimated Primary Completion Date : December 7, 2024
Estimated Study Completion Date : December 16, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Arm Intervention/treatment
Experimental: Tafamidis
Active treatment - 61 mg or if not available, tafamidis megulmine 80 mg
Drug: Tafamidis
Soft gel capsules administered once a day for 60 months




Primary Outcome Measures :
  1. All-cause mortality and incidence of treatment emergent adverse events [ Time Frame: Baseline to Month 60 ]
    Safety endpoints for analysis of the treatment groups


Other Outcome Measures:
  1. Cardiovascular-related mortality [ Time Frame: Baseline to Month 60 ]
    Cardiovascular-related mortality

  2. All-cause hospitalization [ Time Frame: Baseline to Month 60 ]
    Frequency of all-cause hospitalization

  3. Cardiovascular-related hospitalization [ Time Frame: Baseline to Month 60 ]
    Frequency of cardiovascular-related hospitalization

  4. Kansas City Cardiomyopathy Questionnaire [ Time Frame: Baseline to Month 60 ]
    Change from baseline at each visit in Kansas City Cardiomyopathy Questionnaire

  5. New York Heart Association classification [ Time Frame: Baseline to Month 60 ]
    New York Heart Association (NYHA) classification at each visit

  6. Body Mass Index/modified Body Mass Index [ Time Frame: Baseline to Month 60 ]
    Change from baseline in Body Mass Index/modified Body Mass Index at each visit



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02791230


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

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Locations
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United States, Alabama
The Kirkland Clinic of UAB Hospital Recruiting
Birmingham, Alabama, United States, 35233
UAB Hospital Recruiting
Birmingham, Alabama, United States, 35249
Cardiovascular Clinical Trials Unit (CCTU) Recruiting
Birmingham, Alabama, United States, 35294
University Hospital, University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
United States, California
California Heart Center Recruiting
Beverly Hills, California, United States, 90211
Cedars-Sinai Heart Institute Recruiting
Beverly Hills, California, United States, 90211
Altman Clinical Translational Research Institute Recruiting
La Jolla, California, United States, 92037
UCSD Sulpizio Cardiovascular Center Recruiting
La Jolla, California, United States, 92037
University of California, San Diego Clinical and Translational Research Institute - Recruiting
La Jolla, California, United States, 92037
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
University of California, San Diego Medical Center - Hillcrest Recruiting
San Diego, California, United States, 92103
UCSF Ambulatory Care Center Active, not recruiting
San Francisco, California, United States, 94143
University of California Active, not recruiting
San Francisco, California, United States, 94143
UCSF Cardiovascular Care and Prevention Center Active, not recruiting
San Francisco, California, United States, 94158
Stanford Hospital and Clinics Investigational Pharmacy Recruiting
Stanford, California, United States, 94305
Stanford University Hospital and Clinics Recruiting
Stanford, California, United States, 94305
United States, Florida
Sylvester at Deerfield Beach Recruiting
Deerfield Beach, Florida, United States, 33442
University of Miami Hospital & Clinics/Sylvester Comprehensive Cancer Center Recruiting
Miami, Florida, United States, 33136
United States, Illinois
Northwestern Medical Group Recruiting
Chicago, Illinois, United States, 60611
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Advocate Christ Medical Center Recruiting
Oak Lawn, Illinois, United States, 60453
United States, Maryland
University of Maryland, Baltimore Recruiting
Baltimore, Maryland, United States, 21201
University of Maryland, Maryland Recruiting
Baltimore, Maryland, United States, 21201
Johns Hopkins Hospital IDS Pharmacy Active, not recruiting
Baltimore, Maryland, United States, 21287
Johns Hopkins Hospital Active, not recruiting
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Boston Medical Center Investigational Pharmacy Recruiting
Boston, Massachusetts, United States, 02118
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Boston University Medical Center Recruiting
Boston, Massachusetts, United States, 02118
United States, Michigan
Michigan Medicine - Research Pharmacy Recruiting
Ann Arbor, Michigan, United States, 48109
Michigan Medicine,University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Clinic Hospital-Rochester Recruiting
Rochester, Minnesota, United States, 55902
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
United States, New Jersey
Newark Beth Israel Medical Center Recruiting
Newark, New Jersey, United States, 07112
United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Columbia University Medical Center- Clinical Cardiovascular Research Laboratory for the Elderly Recruiting
New York, New York, United States, 10034
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
United States, Oregon
OHSU Center for Health and Healing Recruiting
Portland, Oregon, United States, 97239
OHSU Research Pharmacy Services Recruiting
Portland, Oregon, United States, 97239
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Penn Presbyterian Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
University of Utah Medical Center Recruiting
Salt Lake City, Utah, United States, 84132
Belgium
UZ Leuven Recruiting
Leuven, Belgium, 3000
Brazil
Hospital Universitário Clementino Fraga Filho (UFRJ) Recruiting
Rio de Janeiro, RJ, Brazil, 21941-913
Canada, Alberta
University of Calgary/Foothills Medical Centre Recruiting
Calgary, Alberta, Canada, T2N 4Z6
Czechia
Fakultni nemocnice u sv. Anny v Brne Recruiting
Brno, Czechia, 656 91
Vseobecna fakultni nemocnice v Praze Recruiting
Praha 2, Czechia, 128 08
Institut klinicke a experimentalni mediciny Recruiting
Praha 4, Czechia, 140 21
France
CHU Henri Mondor Recruiting
Creteil, France, 94010
Hopital Bichat Recruiting
Paris, France, 75018
Germany
Medical University of Heidelberg Recruiting
Heidelberg, Germany, 69120
Universitaetsklinikum Muenster Recruiting
Muenster, Germany, 48149
Italy
Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi Recruiting
Bologna, Italy, 40138
Azienda Ospedaliera Universitaria Careggi Recruiting
Firenze, Italy, 50134
Fondazione IRCCS Policlinico San Matteo Recruiting
Pavia, Italy, 27100
Japan
Kurume University Hospital Recruiting
Kurume-shi, Fukuoka, Japan, 830-0011
Kumamoto University Hospital Recruiting
Kumamoto-city, Kumamoto, Japan, 860-8556
Shinshu University Hospital Recruiting
Nagano, Japan, 390-8621
Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9713 GZ
Spain
Hospital Universitario Puerta de Hierro Majadahonda Recruiting
Majadahonda, Madrid, Spain, 28222
Complejo Hospitalario Universitario A Coruña Recruiting
A Coruña, Spain, 15006
Sweden
Skellefteå Lasarett Recruiting
Skellefteå, Sweden, 931 86
Akademiska Sjukhuset Recruiting
Uppsala, Sweden, 751 85
United Kingdom
Barts Health NHS Trust, St Bartholomew's Hospital Recruiting
London, United Kingdom, EC1A 7BE
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02791230     History of Changes
Other Study ID Numbers: B3461045
2016-000868-42 ( EudraCT Number )
First Posted: June 6, 2016    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:
amyloidosis
amyloid
transthyretin
TTR
ATTR-CM

Additional relevant MeSH terms:
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Cardiomyopathies
Amyloidosis
Heart Diseases
Cardiovascular Diseases
Proteostasis Deficiencies
Metabolic Diseases