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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02791230




Registration number
NCT02791230
Ethics application status
Date submitted
1/06/2016
Date registered
6/06/2016
Date last updated
3/05/2024

Titles & IDs
Public title
Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy
Scientific 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)
Secondary ID [1] 0 0
2016-000868-42
Secondary ID [2] 0 0
B3461045
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transthyretin (TTR) Amyloid Cardiomyopathy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tafamidis

Experimental: Tafamidis - Active treatment - 61 mg or if not available, tafamidis megulmine 80 mg


Treatment: Drugs: Tafamidis
Soft gel capsules administered once a day for 60 months
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All-cause mortality and incidence of treatment emergent adverse events
Timepoint [1] 0 0
Baseline to Month 60

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Liver and/or heart transplant, or implanted cardiac mechanical assist device

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/06/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/11/2023
Sample size
Target
Accrual to date
Final
1733
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 0 0
Eastern Health (Box Hill Hospital) - Box Hill
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
California
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United States of America
State/province [3] 0 0
Florida
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United States of America
State/province [4] 0 0
Illinois
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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Minnesota
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Oregon
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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United States of America
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Utah
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Argentina
State/province [17] 0 0
Ciudad Autónoma de Buenos Aires
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Belgium
State/province [18] 0 0
Leuven
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Brazil
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RJ
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Czechia
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Brno
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Czechia
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Praha 2
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Czechia
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Praha 4
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France
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CAN
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France
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Creteil
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France
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Marseille
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France
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Paris
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France
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Rennes
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France
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Toulouse
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Germany
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Heidelberg
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Germany
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Münster
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Hong Kong
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Hong Kong
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Italy
State/province [36] 0 0
Bologna
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Italy
State/province [37] 0 0
Firenze
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Italy
State/province [38] 0 0
Pavia
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Japan
State/province [39] 0 0
Fukuoka
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Japan
State/province [40] 0 0
Kumamoto
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Japan
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Nagano
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Netherlands
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Groningen
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Spain
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LA Coruna
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Spain
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Madrid
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Spain
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A Coruña
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Sweden
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Skellefteå
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Sweden
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Uppsala
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Taiwan
State/province [48] 0 0
Taipei
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United Kingdom
State/province [49] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Open label study to evaluate tafamidis for the treatment of transthyretin cardiomyopathy
Trial website
https://clinicaltrials.gov/ct2/show/NCT02791230
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02791230