16 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 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: 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…
To evaluate and quantify the various clinical effects of closed-loop SCS versus open-loop SCS on the underlying pathophysiological effects in CRPS.
See protocol sectie 2.1 & 2.2
To validate the results from two RCTs that SCS is indeed capable of treating otherwise refractory diabetic neuropathic pain, and to evaluate the effects of burst stimulation settings in this patient group.
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…
To demonstrate that SCS is capable of treating otherwise refractory neuropathic pain after chemotherapy / radiotherapy.
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…
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 (…
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…
The purpose of this study is to assess the safety and effectiveness of the Freedom SCS (spinal cord stimulation) System for the treatment of chronic back and leg pain secondary to failed back surgery syndrome (FBSS) over a follow-up period of one…
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…
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…
To investigate the effect of Roux-en-Y gastric bypass on the rate and extent of absorption of metoprolol and its main active metabolite α-OH metoprolol, after a single oral dose of 95 mg metoprolol CR tablet in 10 female bariatric surgery patient…
The objective of this study is to assess the feasibility of SCS using the Wavewriter Alpha for control of treatment resistant endometriosis-related pain symptoms