20 results
To estimate the bleeding risk with rivaroxaban, compared with ASA, in addition to a singleantiplatelet agent (clopidogrel or ticagrelor), in subjects with a recent ACS .
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…
The objective of this study is to demonstrate (1) the superior efficacy of VTE prophylaxis with oral rivaroxaban 10 mg once daily administered for 35 ± 4 days to SC enoxaparin 40 mg once daily (OD) administered for 10 ± 4 days in men and women aged…
The primary objective of the study is to determine whether rivaroxaban in addition to standard care reduces the risk of the composite of cardiovascular (CV) death, myocardial infarction (MI), or stroke in subjects with a recent ACS compared with…
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…
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…
The purpose of this study is to show that the incidence of new thrombotic events during an additional 6 or 12 months of treatment with rivaroxaban is lower when compared to placebo and that the likely advantage of an extended effect is not offset by…
There are two phases in this trial with 2 objectives:In phase I of the trial it will be assessed which dose of rivaroxaban is the most safe and effective (most optimal benefit:risk profile). In phase II this dose will be further investigated to…
To assess the effect of teriflunomide in comparison to placebo, on frequency of multiple sclerosis (MS) relapses in patients with relapsing forms of MS who are treated with interferon beta (IFN-β)
Primary objectives:*To determine whether rivaroxaban 2.5 mg twice daily (bid) + aspirin 100 mg once daily (od) compared with aspirin 100 mg od reduces therisk of a composite of myocardial infarction, stroke, or cardiovascular death in subjects with…
The primary objective is to demonstrate the non-inferiority of rivaroxaban 10 mg versus enoxaparin 4000 IU relevant to the occurrence of major VTEs up until the end of the treatment (for example, cast or splint removal). The power of the study…
To demonstrate that ofatumumab is superior to teriflunomide in reducing the frequency of confirmed relapses as evaluated by the annualized relapse rate (ARR) in patients with relapsing MS
Primary objective:- To assess the effect of teriflunomide in comparison to placebo on disease activity measured by time to first clinical relapse after randomization in children and adolescents 10 to 17 years of age with relapsing forms of multiple…
Primary: To determine the efficacy of SAR442168 compared to a daily dose of 14 mgteriflunomide (Aubagio) in decreasing relapses in RMS.Secondary:1. To evaluate safety, tolerability, and efficacy of SAR442168 compared to placebo on clinical endpoints…
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…
The goal of the fenebrutinib development program in MS is to evaluate the benefits and risks of fenebrutinib treatment across the spectrum of patients with MS. Based on the existing toxicology, pharmacology, and clinical experience with fenebrutinib…
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…
Main objective:To demonstrate superior efficacy with evobrutinib compared to Teriflunomide in terms of Annualized Relapse Rate (ARR) Secondary objectives:a.To demonstrate the efficacy of evobrutinib relative to that of Teriflunomide on disability…
The purpose of the study is to provide efficacy, safety and tolerability data for remibrutinib to support regulatory approval worldwide as a treatment for relapsing multiple sclerosis (RMS). Two identical Phase III trials (CLOU064C12301 and…