14 results
The primary objective of this study in patients with symptomatic chronic Heart Failure and Preserved left ventricular Ejection Fraction (HF-PEF) is to determine whether ivabradine compared to placebo could improve the diastolic function, the…
The purpose of this study is to demonstrate the beneficial effect of ivabradine on endothelial function in individuals with risk factors for cardiovascular disease and a resting HR * 75 bpm.
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…
The purpose of this study is to assess the safety of the new modified release (MR) formulation of ivabradine administered orally, at titrated doses if necessary, in patients with stable coronary artery disease (CAD) with or without angina pectoris.
The primary objective of this study is to assess the objective response rate (ORR, the percentage of treated patients in whom the tumor significantly reduces in size or becomes non-detectable) of SAR240550 administered as a 60min intravenous…
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 purpose of this study is to demonstrate the beneficial effect of ivabradine on plaque burden, morphology and composition, as well as on arterial wall shear stress (WSS) in patients with CAD who have a clinical indication for coronary angiography…
primary • To determinne the safety and tolerability of sorafenib when administered in combination with gemcitabine and carboplatin.• To determine the maximal tolerated dose (MTD), dose limiting toxicity (DLT) and optimal treatment schedule of…
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: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 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…
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 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…