21 results
The aim of this study is to investigate the effect of body weight on the trough concentrations of DOACs. Eliquis®, Xarelto®, Lixiana® and Pradaxa®
The primary objective is to compare a 12-month antithrombotic regimen of edoxaban in combination with clopidogrel or another P2Y12 antagonist against a regimen of a vitamin K antagonist (VKA) in combination with clopidogrel or another P2Y12…
We propose to conduct a study in patients with mild to moderate AD where a cholinergic challenge is given in a placebo-controlled, cross-over fashion, prior to onset of treatment with a CEI. Patients will be followed over a period of 6 months to…
The primary objective is to demonstrate the non-inferiority of edoxaban (preceded by a short course of LMWH compared with dalteparin for theprevention of the combined outcome of recurrent venous thromboembolism (VTE) or major bleeding in subjects…
Primary Objective: To study the change on performance on executive function and memory function (as measured on Neurocart), after an active challenge with methylphenidate (monoaminergic) and galantamine (cholinergic), compared to placebo, in…
Primary Objective: To assess the ex-vivo anticoagulant potency of Edoxaban in patients with Child Pugh A/B cirrhosis, by means of percentual changes in ex-vivo thrombin generation from baseline compared to steady state. These results will be…
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…
Objective(s)• To evaluate the safety and tolerability after intranasal administration of ascending multiple doses of Memogain in healthy elderly subjects.• To evaluate the PK after intranasal administration of ascending multiple doses of Memogain in…
Primary Objectives • To demonstrate if the impairment of cognitive function caused by mecamylamine administration can be diminished by an nAChR agonist or CEI.• To evaluate to what extent a single dose of 30 mg mecamylamine may cause a more…
We propose to conduct a study in healthy young and elderly subjects and patients diagnosed with mild to moderate AD, FTLD, or DLB where cholinergic and serotonergic challenges are given in a placebo-controlled, crossover fashion. Before each…
To compare the plasma concentration of edoxaban in women with breast cancer before and during treatment with tamoxifen.
1. To compare bleeding risk (i.e. safety) with DAPT compared to standard therapy during the first 30 days following PCI/ACS in patients with AF2. To compare ischemic risk (i.e. efficacy) with DAPT compared to standard therapy during the first 30…
This study is being conducted to collect additional data to describe the safety and tolerability of multiple cycles of IV administration of fosaprepitant daily for 3 consecutive days, concomitantly with a 5-HT3 antagonist, with or without…
To evaluate the safety and efficacy of DOAC versus VKA in CTEPH/CTED patients receiving BPA, based on the composite endpoint of periprocedural bleeding (life-threatening or disabling bleeding, vascular injury or access site problems) and lung injury…
To evaluate the effect of prolonged duration of (fos)aprepitant prophylaxis on the prevention of delayed CINV (complete remission in the 24-72 hours after the final dose of chemotherapy) in children. The current 3-day regimen is compared to a…
To investigate whether treatment with edoxaban leads to a decrease in incidence of leaflet thickening and is clinical efficient and safe.
Primary:• To assess the effects of VMX-C001 and a DOAC on the anticoagulant effect of unfractionated heparin in healthy subjects.Secundary:• To assess the safety and tolerability of VMX-C001 in a simulated emergency use setting.• To assess the…
To demonstrate that oral anticoagulation with the NOAC edoxaban is superior to current therapy (antiplatelet therapy or no therapy depending on cardio-vascular risk) to prevent stroke, systemic embolism, or cardiovascular death in patients with AHRE…
The objective of this study is to evaluate the effect of enzalutamide on morphine and edoxaban pharmacokinetics. This information is urgently needed to optimize the treatment of patients with prostate cancer using enzalutamide and facilitate the…
Primary objective:• To assess, in healthy subjects, the pharmacodynamic (PD) properties of PCC in the presence and absence of selected DOACs.Secondary objectives:• To assess, in healthy subjects, the safety and tolerability of PCC in the presence…