14 results
Primary: Longterm safety and tolerability of AMG 145.Secondary: Longterm efficacy of AMG 145.
Primary Objective: To characterize the safety and tolerability of long-term administration ofAMG 145 among subjects with severe familial hypercholesterolemia
Primary: To evaluate the effect of 12 weeks of subcutaneous (SC) AMG 145 every-2-weeks (Q2W) and every-4-weeks (Q4W), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in subjects with heterozygous…
Primary ObjectivePart A: To characterize the effect of 12 weeks of subcutaneous (SC) AMG 145 on percentchange from baseline in low-density lipoprotein cholesterol (LDL-C) in subjects with homozygousfamilial hypercholesterolemiaPart B: To evaluate…
Primary: To evaluate the effect of 12 weeks of subcutaneous (SC) AMG 145 every-2-weeks (Q2W) and every-4-weeks (Q4W), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C).Secondary objectives:…
Primary: To evaluate the effect of 12 weeks of subcutaneous (SC) AMG 145 every-2-weeks (Q2W) and every-4-weeks (Q4W), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C).Secondary objectives: Safety…
Primary: To evaluate the effect of 12 weeks of subcutaneous (SC) AMG 145, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in subjects with heterozygous familial hypercholesterolemia.Secondary…
The primary objective is to assess the efficacy of alectinib in terms of best overall response (OR) assessed by RECIST v1.1. The secondary objectives are to evaluate secondary measures of clinical efficacy including disease control, progression-free…
The primary objectives for Part 1:-To determine the recommended Phase II dose of RO5424802 to be used in Part 2 of the study-To evaluate the safety and tolerability of 600mg and 900mg doses of RO5424802 administered twice daily to subjects with…
The primary objective will be a prolonged mPFS for the TDM-guided dosing cohort versus the standard fixed dosing cohort in the group of patients with an alectinib Cmin below the threshold of< 435 ng/mL. The secondary objectives are…
Study MX39795 will compare the efficacy and safety of molecularly-guided therapy versusstandard platinum-containing chemotherapy in patients with poor prognosis cancer of unknown primary site(CUP; non-specific subset) who have achieved disease…
The primary objective of the study is to evaluate the efficacy and safety and rIFN-γ as adjunctive treatment in combination with standard therapy for the treatment of patients with candidemia. Efficacy is defined as clearance of candidemia within…
Main objective:To evaluate change over time in executive function, as assessed by the Cambridge Neuropsychological Test Automated Battery (CANTAB) Spatial Working Memory (SWM) strategy index of executive function, in subjects receiving statin…
The overall objectives of this study are to evaluate the efficacy and safety of multiple therapies in patients with locally advanced, unresectable, Stage III NSCLC who are selected according to biomarker status as identified by tissue-based testing.…