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Clinical trials for Tafamidis

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    7 result(s) found for: Tafamidis. Displaying page 1 of 1.
    EudraCT Number: 2016-000868-42 Sponsor Protocol Number: B3461045 Start Date*: 2016-09-26
    Sponsor Name:Pfizer Inc.
    Full Title: A PHASE 3 MULTICENTER, RANDOMIZED, DOUBLE-BLIND, EXTENSION STUDY TO EVALUATE THE SAFETY OF DAILY ORAL DOSING OF TAFAMIDIS MEGLUMINE (PF-06291826) 20 MG OR 80 MG IN SUBJECTS DIAGNOSED WITH TRANSTHYR...
    Medical condition: Transthyretin amyloid cardiomyopathy (TTR-CM)
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004849 10002020 Amyloid cardiomyopathy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) BE (Completed) CZ (Completed) DE (Completed) SE (Completed) NL (Completed) GB (GB - no longer in EU/EEA) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-003158-21 Sponsor Protocol Number: MGNT2022 Start Date*: 2023-04-17
    Sponsor Name:Centro Hospitalar de Trás-os-Montes e Alto Douro (CHTMAD), EPE
    Full Title: MAGNETICAL: MAGNetic resonance Evaluation of Tafamidis Impact in Cardiac AmyLoidosis
    Medical condition: TTR amyloidosis (wild type or hereditary)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10007541 - Cardiac disorders 10007509 Cardiac amyloidosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-003153-28 Sponsor Protocol Number: ALN-TTRSC02-003 Start Date*: 2019-12-23
    Sponsor Name:Alnylam Pharmaceuticals, Inc.
    Full Title: HELIOS-B: A Phase 3 Global, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Outcomes, Efficacy and Safety of Vutrisiran in Patients with Transthyretin Amyloidosis with C...
    Medical condition: Transthyretin Amyloidosis with Cardiomyopathy (ATTR Amyloidosis with Cardiomyopathy)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10007541 - Cardiac disorders 10007509 Cardiac amyloidosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Completed) PT (Trial now transitioned) FR (Trial now transitioned) HU (Trial now transitioned) SI (Completed) NO (Trial now transitioned) IE (Trial now transitioned) LT (Trial now transitioned) ES (Ongoing) AT (Trial now transitioned) DK (Trial now transitioned) DE (Trial now transitioned) GB (GB - no longer in EU/EEA) PL (Trial now transitioned) NL (Trial now transitioned) HR (Trial now transitioned) CZ (Trial now transitioned) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-001458-24 Sponsor Protocol Number: ALN-TTR02-011 Start Date*: 2019-09-19
    Sponsor Name:Alnylam Pharmaceuticals, Inc.
    Full Title: APOLLO-B: A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Patisiran in Patients with Transthyretin Amyloidosis with Cardiomyopathy (...
    Medical condition: Transthyretin Amyloidosis with Cardiomyopathy (ATTR Amyloidosis with Cardiomyopathy)
    Disease: Version SOC Term Classification Code Term Level
    27.0 10007541 - Cardiac disorders 10007509 Cardiac amyloidosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Trial now transitioned) DK (Trial now transitioned) FR (Trial now transitioned) BG (Completed) PT (Trial now transitioned) GB (GB - no longer in EU/EEA) NL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-002465-35 Sponsor Protocol Number: B3461028 Start Date*: 2014-04-07
    Sponsor Name:FoldRx Pharmaceuticals, a Pfizer Company
    Full Title: A multicentre, international, phase 3, double-blind, placebo-controlled, randomized study to evaluate the efficacy, safety and tolerability of daily oral dosing of tafamidis meglumine (PF-06291826)...
    Medical condition: Transthyretin amyloid cardiomyopathy (TTR-CM)
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004849 10002020 Amyloid cardiomyopathy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed) ES (Completed) DE (Completed) SE (Completed) CZ (Completed) NL (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2009-011535-12 Sponsor Protocol Number: Fx1A-303 Start Date*: 2009-08-26
    Sponsor Name:Pfizer Inc.
    Full Title: Open-Label Safety and Efficacy Evaluation of Fx-1006A in Patients with Transthyretin Amyloidosis
    Medical condition: Transthyretin Amyloidosis (ATTR)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10057949 Familial amyloid polyneuropathy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) SE (Completed) FR (Completed) PT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-002987-17 Sponsor Protocol Number: ALN-TTR02-004 Start Date*: 2013-11-25
    Sponsor Name:Alnylam Pharmaceuticals, Inc
    Full Title: APOLLO: A Phase 3 Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Patisiran (ALN-TTR02) in Transthyretin (TTR)-Mediated Polyneu...
    Medical condition: Transthyretin mediated amyloidosis (ATTR)
    Disease: Version SOC Term Classification Code Term Level
    19.0 10007541 - Cardiac disorders 10007509 Cardiac amyloidosis PT
    19.0 10010331 - Congenital, familial and genetic disorders 10019889 Hereditary neuropathic amyloidosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) ES (Completed) PT (Completed) IT (Completed) DE (Completed) NL (Completed) GB (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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