11 results
(1) To assess [11C]phenytoin 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]phenytoin in humans. (3) To determine intra-…
The primary objective of this study is:• To evaluate whether simtuzumab (formally referred to as GS-6624) is effective at preventing the progression of liver fibrosis in subjects with PSC.The secondary objectives of this study include the following…
The primary efficacy objective of this study is to:* Compare the incidences of the composite endpoints of stroke, systemic embolic event (SEE), myocardial infarction (MI) and cardiovascular (CV) mortality between the edoxaban group and the…
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…
The primary objective is to demonstrate the non-inferiority of edoxaban to standard of care (SOC; including low molecular weight heparin (LMWH), or vitamin K antagonist (VKA)) in the treatment and secondary prevention of VTE in pediatric subjects…
The aim of this study is to investigate the effect of body weight on the trough concentrations of DOACs. Eliquis®, Xarelto®, Lixiana® and Pradaxa®
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…
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…
* To assess the effect of Edoxaban versus vitamin K antagonist (VKA) on net adverse clinical events (NACE), i.e., the composite of all-cause death, myocardial infarction (MI), ischemic stroke, systemic thromboembolism (SEE), valve thrombosis, and…
To compare the plasma concentration of edoxaban in women with breast cancer before and during treatment with tamoxifen.
To investigate whether treatment with edoxaban leads to a decrease in incidence of leaflet thickening and is clinical efficient and safe.