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)
ID Number 14-0304Principal Investigator(s)
Peter D Gorevic
Department(s) or Division(s)
The purpose of this study is to compare the effects over 30 months of the study drug tafamidis meglumine (hereafter called tafamidis) at two different doses (20 mg and 80 mg) with placebo to find out which is better for treating Transthyretin Cardiomyopathy (TTR-CM). Subjects will remain on their current standard treatment for their condition. A placebo looks like the study drug but does not contain any drug. Researchers use a placebo to see if the study drug works better or is safer than not taking the study drug.
Tafamidis is a study drug that is being tested for the treatment of transthyretin amyloidosis. The use of tafamidis in this study is investigational. It is investigational because tafamidis is not currently approved to treat TTR-CM. Because this is a research study tafamidis or placebo will be given to you during this study. For those who complete the entirety of this 30-month study the option will be provided to participate in an extension study with tafamidis treatment.
Subjects are being asked to take part in this research study because they have a diagnosis of transthyretin amyloid cardiomyopathy (TTR-CM). The condition causes accumulation of a protein in the heart and increases one's risk of having heart problems. To be eligible for this study a volunteer must have had medical evidence of prior Heart Failure.
Funds for conducting this research are provided by Pfizer the Sponsor of this research study and the manufacturer of the study drug Tafamidis Meglumine (PF-06291826). Participation in this research study is expected to last to approximately 30 month and include up to 14 study visits to the research center.
Recruiting Patients: No