7 results
Primary Objective: Compare the overall survival (OS) of patients receiving gemcitabine plus AG-013736 versus gemcitabine plus placebo.Secondary Objectives: 1. Compare the progression free survival (PFS) of patients in each arm;2. Compare the…
2.1.1 Primary Objective1.Evaluate the LDL-C-lowering effects of ERN/LRPT/SIM 2 g/20 mg compared to ERN/LRPT 2 g coadministered with simvastatin 20 mg.Hypothesis: ERN/LRPT/SIM 2 g/20 mg is equivalent to ERN/LRPT 2 g coadministered with simvastatin 20…
The aim of the study is to determine the efficacy and safety of BHR-100 i.v. progesterone infusion compared to placebo infusion, utilizing the GOS in severe traumatic brain injury patients (GCS 3-8), with the treatment administered continuously over…
To assess the effect of oral UT-15C with PAH-approved oral monotherapy compared to placebo with PAHapproved oral monotherapy on time to first clinical worsening event (adjudicated), as defined by at least one of the events listed below:- Death (all…
Primary objective:- To evaluate the anti-tumor efficacy of HLX10 in combination with chemotherapy and concurrent radiotherapy in subjects with LS-SCLCSecondary objectives:- To evaluate the safety of HLX10 in combination with chemotherapy and…
Primary objectives:Safety for Dose Selection• To assess the safety and tolerability of PQ912Efficacy • To evaluate the efficacy of PQ912 on working memory and attentionSecondary Objectives:Safety• To assess the safety and tolerability of long-term…
Primary objective:* To evaluate the efficacy of norursodeoxycholic acid (norUDCA) 1500 mg vs. norUDCA 1000 mg vs. placebo for the treatment of NASHSecondary objectiveTo study safety and tolerability (adverse events [AEs], laboratory parameters) of…