12 results
Page 18 of the protocol (v1.0, 4-Nov-2013):The primary objectives of this study are:- To evaluate the efficacy of ciprofloxacin DPI administered BID intermittently for 28 days on study treatment / 28 days off study treatment or 14 days on study…
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…
The primary objective of the study is to evaluate the safety and tolerability of CCX354-C in subjects with rheumatoid arthritis (RA) who had an inadequate response to methotrexate treatment.The secondary objectives of the study are to evaluate the…
The primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by a regimen including an alirocumab starting dose of 150 mg Q4W as add-on to non-statin lipid modifying background therapy or as…
Primary objective:To determine the response to a 144-hour (6 day) continuous intravenous infusion of SAGE-547 compared to placebo administered to support the weaning of all third-line agents in subjects with SRSE, and for the response to endure at…
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…
Protocol v1.0 31-Mar-2014, paragraph 2.1-2.4, pages 37-39:The primary objective of this study is: - To determine the efficacy of Olaparib maintenance monotherapy compared to placebo by progression free survival (PFS).The secundary objectives of this…
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…
Primary Objective* To determine the efficacy of EPA-FFA gastro-resistant capsules in patients with FAP in reducing polypectomy.Secondary Objectives* To evaluate the clinical disease progression.* To evaluate the long-term safety and tolerability of…