12 results
Primary Objective: The main objective of this prospective clinical trial is to compare pharmacokinetics and safety and tolerability of a standard dose (400 mg) with an escalated dose of 600 and 800 mg MFX. Secondary Objectives: * To evaluate limited…
This study will test the hypothesis that acute administration of statins will provide for a better protective (anti-inflammatory) effect than chronic administration. Patients used for this study have to undergo mitral and/or tricuspid valve surgery…
The purpose of the study is to investigate the maximum effect of ADASUVE on repolarization of the heart. This is the process where the cells of the heart muscle recharge again after contraction. If this process is strongly slowed down, (potentially…
The purpose of part A of the study is to investigate how safe the study drug is and how well the study drug is tolerated. The study will also investigate how quickly and to what extent the compound is absorbed and eliminated from the body. The…
The combination of simvastatin 10 mg/ezetimibe 10 mg has a beneficial effect on post prandial endothelial function in comparison to monotherapy with simvastatin 80 mg.
The primary objective of the study is to reject the Null hypothesis: A 7 to 21 day therapy with moxifloxacin, 400 mg once daily is more than 10 % less effective than a 7 to 21 day therapy with piperacillin/tazobactam three times daily possibly…
To assess long term safety and toleralibility of Pitavastatin 4 mg QD. To assess the efficacy of Pitavastatin (4 mg) and simvastatin (40 mg and 80 mg QD) in terms of LDL-C target attainment (EAS and NCEP) following 16 weeks and 44 weeks of treatment…
The purpose of Part A is to investigate how safe the study compound is and how well the study compound is tolerated. The study will also investigate how quickly and to what extent the compound is absorbed into and eliminated from the body (this is…
The purpose of the study is to investigate the effect of CBD on specific ECG parameters. Importantly, it will be evaluated if there is a prolongation of the QT interval. When the QT interval is prolonged, repolarization of the heart is delayed. This…
Primary objective- To compare the efficacy of liraglutide versus placebo on weight loss in obese paediatric subjects with PWS at 16 weeks and versus no treatment at 52 weeks.Secondary objectives - To compare the efficacy of liraglutide versus…
The Primary Objectives for the study are:* Demonstrate the non-inferiority (NI) of lefamulin versus comparator with respect to the Early Clinical Response (96 ± 24 hours after the first dose of study drug) in the Intent to Treat (ITT) Analysis Set (…
Part A Pilot:The purpose of Part A is to investigate how quickly and to what extent exenatide is absorbed and eliminated from the body and whether the plasma levels of exenatide will reach the levels seen in patients with renal impairment. It will…