20 results
Primary objective:The primary objective of this study is to evaluate the effect of LCM 200mg bid on the single dose PK and PD of a single warfarin 25mg dose.Secondary objective:The secondary objective of this study is to monitor the safety and…
The goal of this trial is to collect long-term observational data on the tolerability, safety and efficacy of dabigatran etexilate in a spectrum of patients receiving bileaflet mechanical heart valves. All patients that have completed study 1160.113…
The purpose of this study is to confirm/validate predicted dabigatran trough plasma levels gained after individual dose assignment based on simulations by means of PK data from the RE-LY trial. Based on this validation a final appropriate dosing…
Primary objective of this pilot study is to evaluate the in vivo effect of a B2-agonists in CF patients with residual CFTR function, using dosages which are clinically used in patients with asthma. Secondary objective is to evaluate the difference…
See section 2.2. of the protocol.The primary objective of this trial is to assess the safety of an uninterrupted dabigatran etexilate periprocedural anticoagulant regimen compared to an uninterrupted warfarin regimen in NVAF patients undergoing AF…
Primary efficacy objective:To compare descriptively the incidence of the composite of all-cause death, stroke (ischemic, hemorrhagic, or undetermined) and MajorBleeding (International Society on Thrombosis and Hemostasis [ISTH] definition) in the…
See protocol sectie 2.1 & 2.2
To examine the influence of genetic predisposition, genetic factors, infections and lifestyle of mother and child in relation to 1) allergic diseases and childhood astma;2) childhood overweight and obesity; 3) cardiopulmonary fitness and…
Primary: To assess the effect of multiple doses of tasqinimod on the single-dose pharmacodynamics (PD) of warfarin. Secondary: To assess the effect of multiple doses of tasqinimod on the single-dose pharmacokinetics (PK) of warfarin. To assess the…
The primary objective of this study is to demonstrate that the efficacy of rivaroxaban, a direct FXa inhibitor, is non-inferior to that of dose-adjusted warfarin for the prevention of thromboembolic events in subjects with non-valvular atrial…
Primary objective of this study is to evaluate the clinical effect of a long term treatment (8 weeks) with oral B2-agonists in CF patients with residual CFTR function, especially on lung function (spirometry and airway resistance). Secondary…
To assess the efficacy of a loading dose of intravenous salbutamol in children admitted to a PICU for severe acute wheeze or severe acute asthma. Efficacy is measured by the reduction in asthma score (Qureshi) at 1 hour after administration of the…
See section 2.2 of the protocol.The main objective of this study is to compare a DAT regimen of 110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg DE-DAT) and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (…
Primary objectives:- To identify whether EBC can be used as a non-invasive method to measure the PK of salbutamol and tobramycin.- To determine whether the relationship in mild-moderate asthmatics between pulmonary lung function parameters and…
Dual Primary Objectives:* To determine if apixaban is noninferior to VKA (INR target range 2.0-3.0) on the combined endpoint of ISTHmajor or clinically relevant non-major bleeding in patients with NVAF who develop ACS or undergo PCI withplanned…
Primary:To compare the effect of 6 months use of the CIS on adherence to ELLIPTA maintenance therapy when both the subject and the HCP are supplied with data from the maintenance sensor versus no data supplied to the subject and HCP (Arm 1 vs Arm 5…
The primary objectives of this study are:Part A 1. To characterize the effects of single doses of beta-adrenoceptor (*-AR) agonists CST-101, CST-103 and * AR partial agonist CST-109 on the functional domains of the central nervous system (CNS), as…
Certain drugs are administered by using an inhaler (puffs). An inhaler may contain propellant to get the right amount of the medicine into the lungs in the right way. Some of the propellants used in inhalers are greenhouse gasses and are therefore…
Primary objective:To demonstrate superiority of three dose levels of oral NNC0385-0434 versus placebo on percent change in LDL-C from baseline to week 12 in patients with established ASCVD or ASCVD risk on maximally tolerated statin dose and other…
1. To investigate the acute effect of ADRB2 activation, via intravenous administration of salbutamol (250 µg), on 18F-FDG uptake by BAT.2. To assess the acute effect of ADRB2 activation via intravenous administration of salbutamol (250 µg) on…