4 results
Primary Objective:• To determine if orteronel plus prednisone improves overall survival (OS)Key Secondary Objectives: • To determine if orteronel plus prednisone improves radiographic progression-free survival (rPFS)• To determine if orteronel plus…
Primary Objective:To demonstrate that CHF 1535 twice daily is superior to Formoterol twice daily in terms of COPD exacerbations rate during 48 weeks of treatment and in terms of pulmonary function (change in pre-dose morning FEV1 from baseline to 12…
Primary objective:* To determine whether orteronel 300 mg twice daily (BID) plus prednisone 5 mg BID more effectively reduces serum testosterone levels, compared to placebo plus prednisone 5 mg BID, when administered to patients in JapanSecondary…
Primary:-To assess the mass balance profile (ie, excretion in urine and feces) of orteronel after a single oral dose of 400 mg orteronel containing 18.5 kBq (500 nCi) of 14[C]-orteronel-To characterize the pharmacokinetic profile of total…