At a glance
ClinicalIndex Comparison RecordN/ACompleted· 1,214 enrolled
Drug / intervention
Treatment for TTR amyloidosis +1 moredrug
Likely dose
Treatment for TTR amyloidosis 80 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Vyndaqel Capsules Special Investigation - Investigation on Patients With Transthyretin Amyloid Cardiomyopathy
In Brief
An observational study evaluating Treatment for TTR amyloidosis for Transthyretin (TTR) Amyloid Cardiomyopathy. Completed, enrolled 1,214 participants across 1 site.
Detailed Summary
Secondary Data Collection : To confirm the safety and effectiveness profiles under the actual medical practice of Vyndaqel in Japan. This study is conducted in accordance with the protocol even when Vynmac is used, and information the use of Vynmac during the observation period is also collected.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--
Timeline
N/ACompletedFinished
2020202120222023202420252026
First PostedSep 2019
Enrollment StartOct 2019
Primary CompletionMar 2025
TodayJul 2026
First PostedSep 27, 2019
Enrollment StartOct 3, 2019
Primary CompletionMar 27, 2025
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 6.8 years ago
Interventions
Treatment for TTR amyloidosisdrug
The usual adult dose is 80 mg of Tafamidis Meglumine orally once daily. The dose may be reduced if not tolerated.
Treatment for TTR amyloidosisdrug
The usual adult dose is 61 mg of tafamidis orally once daily.