Pfizer B3461028 Study for patients with TTR-CM
Research type
Research Study
Full title
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)
IRAS ID
143976
Contact name
Lisa Anderson
Contact email
Sponsor organisation
FoldRx Pharmaceuticals, a Pfizer Company
Eudract number
2012-002465-35
Research summary
This is a phase 3 study to assess the effectiveness, safety and tolerability of Tafamidis Meglumine in patients diagnosed with TTR-CM (transthyretin cardiomyopathy).
Approximately 170 patients will take part from many centres in Europe. Suitable participants will be randomised(chosen by chance) into three treatment groups (Tafamidis 20 mg, Tafamidis 80 mg,placebo [a dummy drug that contains no active ingredients]). The study drug or placebo will be given in addition to standard of care.
Participants will be expected to be in the study for approximately 30 months during which time they will attend 14 clinic visits. During these visits the following study procedures will be performed: blood tests, urine tests,
electrocardiograms and several clinical examinations. Also to be completed are a series of questionnaires.
It is hoped the results of this study will help in the development of an effective alternative treatment option for patients with TTR-CM.REC name
South Central - Oxford B Research Ethics Committee
REC reference
14/SC/0075
Date of REC Opinion
7 Apr 2014
REC opinion
Further Information Favourable Opinion