CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 441 enrolled
Drug / intervention
Tafamidis +2 moredrug
Likely dose
Tafamidis 20 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/NCT01994889
NCT01994889Phase 3Completed
CompareCT.gov

A MULTICENTER, 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) 20 MG OR 80 MG IN COMPARISON TO PLACEBO IN SUBJECTS DIAGNOSED WITH TRANSTHYRETIN CARDIOMYOPATHY (TTR-CM)

Pfizer·interventional·Posted Nov 26, 2013·Updated Apr 24, 2019

In Brief

A Phase 3 clinical trial evaluating Tafamidis and Placebo for Transthyretin (TTR) Amyloid Cardiomyopathy. Completed, enrolled 441 participants across 80 sites in 13 countries.

Detailed Summary

This Phase 3 study will investigate the efficacy, safety and tolerability of an oral daily dose of 20 mg or 80 mg tafamidis meglumine capsules compared to placebo in subjects with either transthyretin genetic variants or wild-type transthyretin resulting in amyloid cardiomyopathy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTransthyretin (TTR) Amyloid Cardiomyopathy
CountriesBelgium, Brazil, Canada, Czechia, France, Germany, Italy, Japan, Netherlands, Spain, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 26, 2013
Enrollment StartDec 9, 2013
Primary CompletionFeb 7, 2018
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 12.6 years ago

Interventions

Tafamidisdrug

Tafamidis 20 mg in soft gel capsules administered once a day for 30 months

Tafamidisdrug

Tafamidis 80 mg in soft gel capsules administered once a day for 30 months

Placebodrug

Placebo in soft gel capsules administered once a day for 30 months