12 results
Primary:To assess the non-inferiority of the sedative properties of continuous intravenous (i.v.) clonidine compared to continuous i.v. midazolam in mechanically ventilated children and adolescents (0 - <18 years) admitted to a paediatric…
Primary objectives:1) To evaluate the safety and tolerability of multiple doses GAL-021 in healthy volunteers.2) To evaluate the pharmacokinetic profile of multiple doses of GAL-021 in healthy volunteers.3) To evaluate the pharmacodynamic effects at…
• To determine the onset of action of IN MDZ as compared to IV MDZ.• To determine extend and duration of the sedative effects of 2.5 mg and 5 mg IN MDZ. • To estimate the absolute and relative bioavailability and dose proportionality of single doses…
To assess the efficacy of bosentan in neonates with persistent pulmonary hypertension of the newborn (PPHN) who are in need of continued inhaled nitric oxide (iNO) after at least 4 hours of continuous iNO treatment and to evaluate the…
Primary objective:The study has hierarchical co-primary objectives to demonstrate that:- Firstly: dexmedetomidine is at least as effective as sedation with midazolam and daily sedation stops, in maintaining a target depth of sedation in ventilated…
The main objective of this study is to investigate which premedication scheme reduces best the pain during and after a BMAB and reduces best the fear for a possible next BMAB. Other objectives are the influence of the different medication schemes on…
The study will consist of three parts, part A, B and C. The main purpose of the study is to investigate to what extent VX-983 is safe and tolerated. In addition, it will be investigated how quickly and to what extent VX-983 is absorbed and…
The objective of this trial is to demonstrate that bosentan delays disease worsening or death in patients with IPF.
Primary aim:The primary aim of this study is to evaluate the effect of two consecutive infusions of S(+)-ketamine in patients with CRPS-I on pain relief. The design of the study is prospective, randomised, double-blind and placebo-controlled.…
· To determine therapeutic efficacy of Tracleer in patients with active Behcet disease. Furthermore:· To study cytokine and immunological patterns and ET-1levels in those patients.
Identify congenital heart disease patients with exercise-induced pulmonary arterial hypertension. Analyze changes in pulmonary arterial pressures at peak exercise in patients with exercise induced pulmonary arterial hypertension before and after…
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…