13 results
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…
To investigate whether oral administration of dabigatran etexilate in patients with a rhegmatogenous retinal detachment leads to clinical significant dabigatran levels and thrombin inhibiting activity in the vitreous and subretinal fluid.
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…
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 aim of this phase I study is to assess the extent of intestinal absorption of rivaroxaban and dabigatran etexilate in adult patients with short bowel syndrome and treated with long-term TPN.
To asses the comparability of the estimated dabigatran concentration in plasma via calibrated Hemoclot and the measured dabigatran concentrations assessed in a central lab in patients with moderate renal impairment undergoing primary unilateral…
To provide single dose PK/PD dataTo investigate tolerability and safety of dabigatran etexilate solution in children1 to <12 years of age
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 protocol sectie 2.1 & 2.2
Primary- To evaluate the tumor objective response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria in subjects who receive sotorasib at either 960 mg daily (QD) or 240 mg QD whose tumors are PD-L1 Tumor…
- Primary Objective:To evaluate the safety and tolerability of investigational regimens of sotorasib in adult subjects with KRAS p.G12C mutant advanced solid tumors- Secondary Objectives:To characterize PK of product(s) used in investigational…
Objective: The primary objective of this study is to investigate the potential of the custom global screening array (GSA) in patients with autoinflammatory disorders. We aim to investigate whether the GSA can pick up genetic variants in genes known…
To evaluate management strategies in premenopausal women with heavy menstrual bleeding associated with factor Xa inhibitor therapy.