4 results
The primary objective of the study is to determine whether the optimal atrioventricular delay and interventricular delay in cardiac resynchronization therapy are a function of exercise. Secondary objectives are the development of an automatic…
There will be three formal interim analyses during the study. Interim Analysis 1 will occur at the end of Phase II when approximately 162 PFS events (defined as disease progression or death due to any cause, whichever occurs first) have been…
The primary objective is to evaluate the safety and efficacy of the PulseCath during support of patients with impaired ventricular function, for a period between 24 hours minimum and 14 days maximum. Safety will be assessed by the incidence of…
Primary objective:* To evaluate the efficacy of norursodeoxycholic acid (norUDCA) 1500 mg vs. norUDCA 1000 mg vs. placebo for the treatment of NASHSecondary objectiveTo study safety and tolerability (adverse events [AEs], laboratory parameters) of…