8 results
The primary efficacy objective of the study is:* to evaluate whether rivaroxaban added to ASA is superior to ASA alone in reducingthe risk of major thrombotic vascular events (defined as MI, ischemic stroke, CVdeath, ALI, and major amputation of a…
OBJECTIVESPrimary ObjectiveThe primary objective is to evaluate the efficacy, safety, and tolerability of 800 and 1,200 mg/day of carisbamate compared with placebo in reducing the average daily pain in subjects with diabetic peripheral neuropathy (…
To assess the normalization (reversal) of coagulation assays upon administration of two dosages of Prothrombin Complex Concentratre (PCC, Cofact®) in healthy volunteers treated with either rivaroxaban or apixaban
Study questionWhat is the effect of a single administration of prothrombin complex concentrate (CoFact) on the anticoagulant effect of a novel oral thrombin inhibitor (Dabigatran) and a novel oral factor Xa inhibitor (Rivaroxaban) in healthy human…
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…
Primary Objective:• To evaluate the safety and tolerability of danavorexton single IV infusion administered in healthy subjects undergoing OIRD.Secondary Objective:• To assess the PK of danavorexton single IV infusion administered in healthy…
The primary objective is to demonstrate that rivaroxaban is superior to placebo in subjects with chronic HF and significant CAD, who are receiving standard care, in reducing the risk of the composite of ACM, MI, or stroke following a recent…
The overall objective of this trial will be to evaluate the efficacy and safety of clinical surveillance without anticoagulation in low-risk patients with isolated SSPE. Objective 1: To compare the frequency of symptomatic, recurrent venous…