13 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…
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…
To determine the benefit of Dimebon as compared to placebo on the primary measure of cognition and memory, the Alzheimer*s Disease Assessment Scale * cognitive subscale (ADAS-cog); andTo determine the benefit of Dimebon as compared to placebo on 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…
To study how the registered medicine Midazolam is absorbed, broken-down and excreted by the body after or without administration of multiple doses of the test compound.To study how the registered medicine Dextromethorphan is absorbed, broken-down…
The study will be performed in 3 parts, Parts 1, 2 and 3. In all parts, the purpose is to investigate to what extent APX001 is tolerated. In addition, it will be investigated how quickly and to what extent APX001 is absorbed and eliminated from the…
In this study we will investigate how safe the new compound deramciclane is, when it is given alone and in combination with the existing medication dextromethorphan (Part B), and how well it is tolerated when it is used by healthy elderly…
Part IPrimary: • To evaluate safety and tolerability of ODM-111 in single oral escalating doses compared to placeboSecondary: • To evaluate pharmacokinetics (PK) and pharmacodynamic (PD) effects of ODM-111 after administration of single escalating…
The purpose of this study is to assess the safety and tolerability of intravenous 131I-TLX101 administered concomitantly and sequentially with standard of care in patients newly diagnosed with GBM, to determine the MTD and the R2PD.
Primary Objective (Cohort 1)To demonstrate a sustained effect of A4250 on serum bile acids and pruritus in children with progressive familial intrahepatic cholestasis (PFIC) Types 1 and 2.Primary Objective (Cohort 2)To evaluate the effect of A4250…
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…