6 results
The overall objective of this study is to evaluate the efficacy and safety of neoGAA in treatment-naïve patients with LOPD as compared to alglucosidase alfa, when this is administered biweekly for a period of 49 weeks. Also, there is an open-label…
In the present clinical investigation, we will perform an analysis of baseline risk factors to identify predictors for appropriate ICD intervention in patients with ischemic cardiomyopathy receiving an ICD for primary prevention (MADIT II population…
Primary ObjectiveThe primary objective of this study is to evaluate glycogen clearance in muscle tissue samples collected pre and post alglucosidase alfa treatment in patients with late-onset Pompe disease.Secondary ObjectivesThe secondary…
Demonstrate the sensitivity of the diagnostic feature "Physiological Diagnostic" (PhD) to detect clinically relevant HF-related events and to demonstrate a reasonable number of false positive indications.
The primary objective is to compare change in weekly average daily pain score (ADPS) from baseline to Week 13 in subjects receiving either dose of DS-5565 versus placebo. Weekly ADPS is based on daily pain scores reported by the subject that best…
(1) to determine the feasibility to sense and pace the myocardium with an- ICD lead placed in an alternative position (2) to determine the best position for pacing and sensing in the alternative position(3) to determine the safety and feasibility to…