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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 : June 4, 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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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: June 4, 2019
Last Verified: May 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