49 results
The main objective of this study is to investigate if the occurrence of cognitive impairment and functional reorganization *defined as increased functional activation in cognitively preserved patients- in MS can be explained by changes in GABA and…
To determine the efficacy and safety of MEDI4736 evaluated as a single agent or in combination with tremelimumab in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) whose disease has progressed on 5-FU-containing or gemcitabine-…
Primary objective: To evaluate the efficacy of dupilumab, compared with placebo, for reducing the use of maintenance oral corticosteroids (OCS) in patients with severe steroid-dependent asthma.Secondary objectives:To evaluate the safety and…
Subjects randomized to the placebo treatment are unlikely to benefit from the study. However, OAB is not a life-threatening disease and it is not expected that a 12 to 15 week exposure to placebo treatment will have a negative impact on disease…
The primary objective of the study is to determine if the treatment of AMG 479 at 12 mg/kg and/or 20 mg/kg in combination with gemcitabine improves overall survival as compared with placebo in combination with gemcitabine in subjects with metastatic…
In this trial will be investigated if a new formulation of valacyclovir, e.g. oral solution, is bioequivalent to valacyclovir tablets. This comparison will be made by determining pharmacokinetic parameters (AUC0-*, Cmax, and tmax) of both…
In this proposed study, we aim to test not only the safety and biodistribution of [68Ga]Sarabesin 3, but also its potential to visualise prostate cancer. If the peptide proves to be successful, a next study will be initiated to test the potential to…
To determine the influence of OATP1B inhibition, through rifampicin exposure, on the metabolism and plasma pharmacokinetics of sorafenib and its metabolites.
To assess safety and tolerability of EFI patients with PAH.
To primary objective is to demonstrate a reduction in lipoteichoic acid release in patients with pneumococcal pneumonia treated with rifampicin. This will be done by measuring lipoteichoic acid in serum and urine.Evaluable patients for Intention-to-…
- To evaluate the change in cardiac hemodynamics from baseline to 3-month following switch from Flolan to EFI in patients with PAH.- To evaluate the safety and tolerability of switching from Flolan to EFI in patients with PAH.- To evaluate the…
To determine whether aleglitazar reduces cardiovasculair mortality and morbidity (defined as non-fatal myocardial infarction (MI) and non-fatal stroke) in patients with a recent ACS event and type 2 diabetes.
The key objective of this study is to assess next-day residual effects of MK-4305 (20 and 40 mg) via driving performance after 1 day of dosing and after 8 days of dosing.
(1) To assess [11C]laniquidar plasma and brain kinetics in healthy volunteer(s), including assessment of the presence of radioactive metabolites in plasma. (2) To develop a tracer kinetic model for [11C]laniquidar in humans. (3) To determine intra-…
Primary Objective:To assess the effect of UT-15C sustained release (SR) tablets on exercise capacity compared to placebo (as measured by the change in 6-Minute Walk distance from Baseline to Week 16) in subjects with PAH.Secondary objective:To…
Primary : To assess the effect of multiple doses of rifampicin on the single-dose pharmacokinetics (PK) of tasquinimodSecondary : To assess the safety and tolerability of multiple doses of rifampicin with a single dose of tasquinimod
This study is a proof-of-efficacy, dose finding study of LCI699 in patients with mild-to-moderate uncomplicated essential hypertension in order to assess whether the BP effect, safety and tolerability of LCI699 as compared to those of placebo…
To evaluate the safety, tolerability and efficacy of 3 doses of vernakalant (oral) (150 mg, 300 mg and 500 mg b.i.d.) administered for up to 90 days in subjects with sustained symptomatic atrial fibrillation (AF duration > 72 hours and &…
Evaluation of the safety and tolerability of Bevacizumab added to standard induction chemotherapy. Evaluation of the effect of Bevacizumab on the CR rate
The goal of this trial is to confirm that eradication rates obtained with Pylera are compatible to those obtained with the current European gols standard, OAC 7 days. This trial will constitute a pivotal trial leading eventually to approval of…