3 results
Approved WMOCompleted
To evaluate the long-term safety, tolerability and efficacy of ArikaceTM 590 mg for a maximum 12 cycles administered once daily, where each cycle consists of 28 days on treatment followed by 28 days off treatment.
Approved WMOCompleted
Primary Objective1. To evaluate the efficacy of LAI (590 mg) administered once daily (QD), when added to a multi-drug regimen, for achieving culture conversion (3 consecutive monthly negative sputum cultures) by Month 6 compared to a multi-drug…
Approved WMOCompleted
Demonstrate that the usage of a quadripolar LV lead results in easier LV lead implantation procedure and less chronic LV lead related adverse events in comparison with a traditional biventricular left ventricle lead.