4 results
The objective of this study is to determine the efficacy, safety, and tolerability of tafamidis in subjects with transthyretin cardiomyopathy.The primary objective is to assess the efficacy, safety, and tolerability of an oral dose of 20 mg or 80 mg…
This study, a three-phased cross-over study, aims to define a proper formulation for oral and oromucosal melatonin by investigating the Tmax and relative bioavailability derived from melatonin levels in salivary samples of healthy volunteers after…
The primary objective of this study is to evaluate the effects of intrathecal (IT) administration of SHP611 (also known as TAK-611) on the time to loss of locomotion, as indicated by category 5 or higher in the Gross Motor Function Classification in…
To obtain additional, long term, safety data for tafamidis in subjects with transthyretin amyloid cardiomyopathy (ATTR CM). To provide investigational product, tafamidis, to ATTR CM subjects who complete 30 months of blinded treatment on protocol…