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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02791230
Ethics application status
Date submitted
1/06/2016
Date registered
6/06/2016

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
NA
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
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
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
State/province [5] 0 0
Maryland
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United States of America
State/province [6] 0 0
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
State/province [9] 0 0
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
State/province [14] 0 0
Pennsylvania
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United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Utah
Country [17] 0 0
Argentina
State/province [17] 0 0
Ciudad Autónoma de Buenos Aires
Country [18] 0 0
Belgium
State/province [18] 0 0
Leuven
Country [19] 0 0
Brazil
State/province [19] 0 0
RJ
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Canada
State/province [20] 0 0
Alberta
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Canada
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British Columbia
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Canada
State/province [22] 0 0
Ontario
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Canada
State/province [23] 0 0
Quebec
Country [24] 0 0
Czechia
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Brno
Country [25] 0 0
Czechia
State/province [25] 0 0
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
State/province [33] 0 0
Heidelberg
Country [34] 0 0
Germany
State/province [34] 0 0
Münster
Country [35] 0 0
Hong Kong
State/province [35] 0 0
Hong Kong
Country [36] 0 0
Italy
State/province [36] 0 0
Bologna
Country [37] 0 0
Italy
State/province [37] 0 0
Firenze
Country [38] 0 0
Italy
State/province [38] 0 0
Pavia
Country [39] 0 0
Japan
State/province [39] 0 0
Fukuoka
Country [40] 0 0
Japan
State/province [40] 0 0
Kumamoto
Country [41] 0 0
Japan
State/province [41] 0 0
Nagano
Country [42] 0 0
Netherlands
State/province [42] 0 0
Groningen
Country [43] 0 0
Spain
State/province [43] 0 0
LA Coruna
Country [44] 0 0
Spain
State/province [44] 0 0
Madrid
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Spain
State/province [45] 0 0
A Coruña
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Sweden
State/province [46] 0 0
Skellefteå
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Sweden
State/province [47] 0 0
Uppsala
Country [48] 0 0
Taiwan
State/province [48] 0 0
Taipei
Country [49] 0 0
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02791230