8 results
The primary objective is to evaluate the efficacy of prucalopride compared to placebo for the treatment of functional constipation in a paediatric population, aged *6 months to <18 years. Secondary objectives include:1. Investigation of the…
Primary Efficacy Objective:• To evaluate the efficacy of tocilizumab (TCZ) compared to placebo, in combination with a26-week prednisone taper regimen, in patients with giant cell arteritis (GCA), as measured by the proportion of patients in…
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…
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…
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…
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…
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…