5 results
To assess real world experience with HeartMate PHP post CE Mark approval in supporting patients who are hemodynamically unstable, or at risk of being hemodynamically unstable, while undergoing complex percutaneous coronary interventions (PCI).
Primary Objective:To evaluate the efficacy and safety of solifenacin succinate o.d. in children and adolescents with OABSecondary Objective:To perform population pharmacokinetics after multiple-dose administration.
To evaluate the safety and efficacy of solifenacin succinate suspension once daily in children and adolescents with OAB.
The primary objective of this study is to assess reasonable safety and performance of the HeartMate PHP to provide hemodynamic support for up to 72 hours in patients with cardiogenic shock requiring stabilization.
Primary end points:Safety (>1 toxic death per arm) and tolerability (relevant grade 4 toxicities) in not more than 33% of patients for the three treatment arms.Secondary end points:* Reduction of grade 2-4 key side effects in the experimental…