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Trial record 1 of 1 for:    NCT02791230
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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 : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE June 1, 2016
First Posted Date  ICMJE June 6, 2016
Last Update Posted Date October 4, 2019
Actual Study Start Date  ICMJE June 13, 2016
Estimated Primary Completion Date December 7, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2016)
All-cause mortality and incidence of treatment emergent adverse events [ Time Frame: Baseline to Month 60 ]
Safety endpoints for analysis of the treatment groups
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02791230 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: October 2, 2019)
  • Cardiovascular-related mortality [ Time Frame: Baseline to Month 60 ]
    Cardiovascular-related mortality
  • All-cause hospitalization [ Time Frame: Baseline to Month 60 ]
    Frequency of all-cause hospitalization
  • Cardiovascular-related hospitalization [ Time Frame: Baseline to Month 60 ]
    Frequency of cardiovascular-related hospitalization
  • Kansas City Cardiomyopathy Questionnaire [ Time Frame: Baseline to Month 60 ]
    Change from baseline at each visit in Kansas City Cardiomyopathy Questionnaire
  • New York Heart Association classification [ Time Frame: Baseline to Month 60 ]
    New York Heart Association (NYHA) classification at each visit
  • 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
  • Cardiac biomarkers [ Time Frame: Baseline to Month 60 ]
    Change from baseline in NT-proBNP concentration at each visit
  • Cardiac biomarkers [ Time Frame: Baseline to Month 60 ]
    Change from baseline in Troponin I concentration at each visit
Original Other Pre-specified Outcome Measures
 (submitted: June 1, 2016)
  • Cardiovascular-related mortality [ Time Frame: Baseline to Month 60 ]
    Cardiovascular-related mortality
  • All-cause hospitalization [ Time Frame: Baseline to Month 60 ]
    Frequency of all-cause hospitalization
  • Cardiovascular-related hospitalization [ Time Frame: Baseline to Month 60 ]
    Frequency of cardiovascular-related hospitalization
  • Kansas City Cardiomyopathy Questionnaire [ Time Frame: Baseline to Month 60 ]
    Change from baseline at each visit in Kansas City Cardiomyopathy Questionnaire
  • New York Heart Association classification [ Time Frame: Baseline to Month 60 ]
    New York Heart Association (NYHA) classification at each visit
  • 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
 
Descriptive Information
Brief Title  ICMJE Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy
Official Title  ICMJE 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)
Brief Summary Open label study to evaluate tafamidis for the treatment of transthyretin cardiomyopathy
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Transthyretin (TTR) Amyloid Cardiomyopathy
Intervention  ICMJE Drug: Tafamidis
Soft gel capsules administered once a day for 60 months
Study Arms  ICMJE Experimental: Tafamidis
Active treatment - 61 mg or if not available, tafamidis megulmine 80 mg
Intervention: Drug: Tafamidis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 29, 2019)
2000
Original Estimated Enrollment  ICMJE
 (submitted: June 1, 2016)
330
Estimated Study Completion Date  ICMJE December 16, 2024
Estimated Primary Completion Date December 7, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Brazil,   Canada,   Czechia,   France,   Germany,   Italy,   Japan,   Netherlands,   Spain,   Sweden,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02791230
Other Study ID Numbers  ICMJE B3461045
2016-000868-42 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP