Vyndaqel Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
NCT ID: NCT02146378
Last Updated: 2025-02-03
Study Results
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View full resultsBasic Information
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COMPLETED
500 participants
OBSERVATIONAL
2014-01-10
2023-03-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
OTHER
Study Groups
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Vyndaqel
Vyndaqel
20mg/day
Interventions
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Vyndaqel
20mg/day
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
References
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Konishi H, Abe H, Matsumoto N, Endo Y, Sekijima Y, Ueda M, Ando Y. Real-World Utilization Patterns, Safety, and Efficacy of Tafamidis in Patients With Hereditary Transthyretin Amyloidosis in Japan. Curr Ther Res Clin Exp. 2025 Apr 14;102:100793. doi: 10.1016/j.curtheres.2025.100793. eCollection 2025.
Ishii T, Hirano Y, Matsumoto N, Takata A, Sekijima Y, Ueda M, Ando Y. Characteristics of Patients with Hereditary Transthyretin Amyloidosis and an Evaluation of the Safety of Tafamidis Meglumine in Japan: An Interim Analysis of an All-case Postmarketing Surveillance. Clin Ther. 2020 Sep;42(9):1728-1737.e6. doi: 10.1016/j.clinthera.2020.07.001. Epub 2020 Aug 12.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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NCT02146378
Identifier Type: REGISTRY
Identifier Source: secondary_id
B3461042
Identifier Type: -
Identifier Source: org_study_id
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