5 results
The present proposal seeks to compare the cardiovascular and gastrointestinal safety and effectiveness of a strategy of initial randomisation to treatment with the selective COX-2 inhibitor celecoxib or to *usual-care* with their current non-…
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…
Please refer to protocol, section 1.2 "Rationale"
PrimaryThe primary objective for Part A of the study is to assess the pharmacokinetics (PK) of evinacumab in pediatric patients with homozygous familial hypercholesterolemia (HoFH).The primary objective for Part B of the study is to demonstrate a…
The primary objectives of the study are- To evaluate the long-term safety and tolerability of evinacumab 15 mg/kg intravenous (IV) administered every 4 weeks (Q4W) in patients with homozygous familial hypercholesterolemia (HoFH).- To evaluate the…