ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 26 for:    tafamidis

Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02791230
Recruitment Status : Recruiting
First Posted : June 6, 2016
Last Update Posted : December 10, 2018
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.

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

  Hide Study Locations
Locations
United States, Alabama
The Kirkland Clinic of UAB Hospital Not yet recruiting
Birmingham, Alabama, United States, 35233
UAB Hospital Not yet recruiting
Birmingham, Alabama, United States, 35249
Cardiovascular Clinical Trials Unit (CCTU) Not yet recruiting
Birmingham, Alabama, United States, 35294
University Hospital, University of Alabama at Birmingham Not yet recruiting
Birmingham, Alabama, United States, 35294
United States, California
California Heart Center Active, not recruiting
Beverly Hills, California, United States, 90211
Cedars-Sinai Heart Institute Active, not recruiting
Beverly Hills, California, United States, 90211
Altman Clinical Translational Research Institute Active, not recruiting
La Jolla, California, United States, 92037
UCSD Sulpizio Cardiovascular Center Active, not recruiting
La Jolla, California, United States, 92037
University of California, San Diego Clinical and Translational Research Institute - Active, not recruiting
La Jolla, California, United States, 92037
Cedars-Sinai Medical Center Active, not recruiting
Los Angeles, California, United States, 90048
University of California, San Diego Medical Center - Hillcrest Active, not 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 Active, not recruiting
Stanford, California, United States, 94305
Stanford University Hospital and Clinics Active, not recruiting
Stanford, California, United States, 94305
United States, Florida
Sylvester at Deerfield Beach Active, not recruiting
Deerfield Beach, Florida, United States, 33442
University of Miami Hospital & Clinics/Sylvester Comprehensive Cancer Center Active, not recruiting
Miami, Florida, United States, 33136
United States, Illinois
Northwestern Medical Group Active, not recruiting
Chicago, Illinois, United States, 60611
Northwestern Memorial Hospital Active, not recruiting
Chicago, Illinois, United States, 60611
Northwestern University Active, not recruiting
Chicago, Illinois, United States, 60611
Advocate Christ Medical Center Active, not 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 Active, not recruiting
Newark, New Jersey, United States, 07112
United States, New York
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 Active, not 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 Active, not recruiting
Nashville, Tennessee, United States, 37232
United States, Utah
University of Utah Active, not recruiting
Salt Lake City, Utah, United States, 84112
University of Utah Medical Center Active, not recruiting
Salt Lake City, Utah, United States, 84132
Belgium
UZ Leuven Active, not recruiting
Leuven, Belgium, 3000
Brazil
Hospital Universitário Clementino Fraga Filho (UFRJ) Active, not recruiting
Rio de Janeiro, RJ, Brazil, 21941-913
Canada, Alberta
University of Calgary/Foothills Medical Centre Active, not recruiting
Calgary, Alberta, Canada, T2N 4Z6
Czechia
Fakultni nemocnice u sv. Anny v Brne Active, not recruiting
Brno, Czechia, 656 91
Vseobecna fakultni nemocnice v Praze Active, not recruiting
Praha 2, Czechia, 128 08
Institut klinicke a experimentalni mediciny Active, not recruiting
Praha 4, Czechia, 140 21
France
CHU Henri Mondor Active, not recruiting
Creteil, France, 94010
Hopital Bichat Active, not recruiting
Paris, France, 75018
Germany
Medical University of Heidelberg Active, not recruiting
Heidelberg, Germany, 69120
Universitaetsklinikum Muenster Active, not recruiting
Muenster, Germany, 48149
Italy
Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi Active, not recruiting
Bologna, Italy, 40138
Azienda Ospedaliera Universitaria Careggi Active, not recruiting
Firenze, Italy, 50134
Fondazione IRCCS Policlinico San Matteo Active, not recruiting
Pavia, Italy, 27100
Japan
Kurume University Hospital Active, not recruiting
Kurume-shi, Fukuoka, Japan, 830-0011
Kumamoto University Hospital Active, not recruiting
Kumamoto-city, Kumamoto, Japan, 860-8556
Shinshu University Hospital Active, not recruiting
Nagano, Japan, 390-8621
Netherlands
University Medical Center Groningen Active, not recruiting
Groningen, Netherlands, 9713 GZ
Spain
Hospital Universitario Puerta de Hierro Majadahonda Active, not recruiting
Majadahonda, Madrid, Spain, 28222
Sweden
Skellefteå Lasarett Active, not recruiting
Skellefteå, Sweden, 931 86
Akademiska Sjukhuset Active, not recruiting
Uppsala, Sweden, 751 85
United Kingdom
Barts Health NHS Trust, St Bartholomew's Hospital Active, not recruiting
London, United Kingdom, EC1A 7BE
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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: December 10, 2018
Last Verified: December 2018

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:
Cardiomyopathies
Amyloidosis
Heart Diseases
Cardiovascular Diseases
Proteostasis Deficiencies
Metabolic Diseases