CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 53 enrolled
Drug / intervention
Tafamidisdrug
Likely dose
Tafamidis 61 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.

Search/NCT04814186
NCT04814186Phase 4Completed
CompareCT.gov

A Study to Characterize the Safety and Efficacy of Tafamidis Once Daily in the Treatment of Transthyretin Amyloid Cardiomyopathy in Chinese Participants

Pfizer·interventional·Posted Mar 24, 2021·Updated Dec 18, 2024

In Brief

A Phase 4 clinical trial evaluating Tafamidis for Transthyretin Amyloid Cardiomyopathy. Completed, enrolled 53 participants across 9 sites.

Detailed Summary

This is a national, multi-center, single-arm study, open-label to patients with symptomatic Transthyretin amyloid cardiomyopathy (ATTR-CM) who are tafamidis naïve. This study is to obtain safety, descriptive efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) data for tafamidis orally once daily. Subject eligibility for participation in the study will receive tafamidis once daily or 12 months following the assessment as the screening and baseline, month 1, 3, 6, 9 and 12 visits (or Early Study Discontinuation).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTransthyretin Amyloid Cardiomyopathy
CountriesChina
Collaborators--

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedMar 24, 2021
Enrollment StartJul 22, 2021
Primary CompletionOct 16, 2023
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 5.3 years ago

Interventions

Tafamidisdrug

61 mg, once daily, oral administration, for 12 months.