60 results
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…
For the Einstein-DVT evaluation. The primary efficacy objective is to evaluate whether rivaroxaban is at least as effective as enoxaparin/VKA in the treatment of patients with acute symptomatic deep-vein thrombosis (DVT) without symptomatic…
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…
In this study, the main clinical hypothesis is that the TIMI clinically significant bleeding rates will not be different between the rivaroxaban and VKA treatment strategy groups at Month 12.
-Assess the incidence of major bleeding and clinically relevant non-major bleeding -Assess the incidence of recurrent venous thromboembolism -Characterize the pharmacokinetic/ pharmacodynamic profile of a 30-day treatment with oral rivaroxaban
Primary objective: To test for the first time in a double-blind randomized, placebo controlled trial whether three years treatment with metformin 1000 mg bd added to titrated insulin therapy (towards target HbA1c 7.0%/ 53 mmol/mol) reduces…
To determine the within and between variability of pharmacokinetic (PK) profiles in patients treated with DOACs in daily practice
The primary objective of the phase I part of the study is to determine the recommended phase II dose of metformin in combination with carboplatin/paclitaxel chemotherapy in patients with advanced ovarian cancer. The secondary objectives the phase I…
Objectives:To collect data on effect size for, and determine the feasibility of, a full scale multicentre RCT(Randomized Controlled Trial) that1. compares the efficacy and safety of NOACs with VKA treatment according to Dutchstandards, in VKA-…
The primary objective of the METFORMIN study is to determine the efficacy of metformin in combination with lifestyle-intervention in obese children and adolescents with insulin resistance versus placebo with lifestyle-intervention. The secondary…
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
Treatment of overweight persons with insulinresistance with a low dose metformin added to yoghurt. The early reduction of glucose, especially the postprandial glucose will hopefully slow the process from insuline resistance to diabetes mellitus.…
treatment of overweight persons with insulinresistance with a low dose metformine add to yoghurt The early reduce of glucose especially the postprandial will hopefully decrease this process. This reduce of the glucose only needs to be 1 mmol and we…
The aim of this study is to assess whether rivaroxaban, as compared to UFH, on the background of standard dual antiplatelet therapy (DAPT), can effectively suppress thrombosis, and related adverse ischemic events, upon balloon inflation and stent…
To examine the safety, tolerability, and effect on glucose metabolism of metformin treatment in non-diabetic patients with TIA or minor ischemic stroke and impaired glucose tolerance.
The objective of the study is to evaluate the efficacy of the addition of SYR-322 (25 mg) to subjects who are inadequately controlled on pioglitazone HCl (30 mg) and metformin (*1500 mg or MTD).
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…
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…
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…