5 results
The Primary Objectives for the study are:* Demonstrate the non-inferiority (NI) of lefamulin versus comparator with respect to the Early Clinical Response (96 ± 24 hours after the first dose of study drug) in the Intent to Treat (ITT) Analysis Set (…
Our proposed randomized controlled trial is the first making this head-to-head comparison in a *real life* primary care setting in the Netherlands. The primary research question is: does a 12-week combination therapy of open label varenicline and…
The primary objective is to compare the efficacy of moxifloxacin 400 mg PO OD for five days with the respective efficacy of amoxicillin clavulanic acid 875/125 mg PO BID for seven days in the treatment of subjects with AECB. The primary efficacy…
The primary objective of the study is to reject the Null hypothesis: A 7 to 21 day therapy with moxifloxacin, 400 mg once daily is more than 10 % less effective than a 7 to 21 day therapy with piperacillin/tazobactam three times daily possibly…
Primary Objective:The primary objective is to evaluate the effects of various doses of BMS-986231 compared to placebo on clinically relevant hypotension (defined by SBP < 90 mm Hg or symptoms of hypotension)Secondary Objectives:* Assess the…