19 results
To provide access to Radium-223 dichloride to patients diagnosed with CRPC/HRPC with bonemetastasis.
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…
Primary efficacy objective:To compare descriptively the incidence of the composite of all-cause death, stroke (ischemic, hemorrhagic, or undetermined) and MajorBleeding (International Society on Thrombosis and Hemostasis [ISTH] definition) in the…
The objective of this trial is to compare standard treatment with radium-223-chloride (proven surivval benefit) with treatment with rhenium-188-HEDP, which is nowadays only used for pain palliation. This trial includes patients with metastatic…
The objective of this study is to assess efficacy and safety of radium 223 dichloride in combination with exemestane and everolimus in subjects with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor positive breast cancer…
The objective of this study is to assess the efficacy and safety of radium-223 dichloride in subjects with human epidermal growth factor receptor 2 negative (HER2 negative), hormone receptor positive breast cancer with bone metastases treated with…
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…
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…
This Phase 2 study for JNJ-63733657 will assess the possible slowing of cognitive decline seen inprodromal AD and mild AD dementia (Early AD). In addition, effects of JNJ-63733657 on theaccumulation of tau, as measured by tau positron emission…
1. To compare bleeding risk (i.e. safety) with DAPT compared to standard therapy during the first 30 days following PCI/ACS in patients with AF2. To compare ischemic risk (i.e. efficacy) with DAPT compared to standard therapy during the first 30…
To compare the plasma concentration of edoxaban in women with breast cancer before and during treatment with tamoxifen.
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…
To evaluate the safety and efficacy of DOAC versus VKA in CTEPH/CTED patients receiving BPA, based on the composite endpoint of periprocedural bleeding (life-threatening or disabling bleeding, vascular injury or access site problems) and lung injury…
Primary:• To assess the effects of VMX-C001 and a DOAC on the anticoagulant effect of unfractionated heparin in healthy subjects.Secundary:• To assess the safety and tolerability of VMX-C001 in a simulated emergency use setting.• To assess the…
To investigate whether treatment with edoxaban leads to a decrease in incidence of leaflet thickening and is clinical efficient and safe.
to provide access to Radium-223 dichloride together with abiraterone and prednisone to patients diagnosed with CRPC with bonemetasasis.
Primary objective:Compare overall survival for subjects treated with docetaxel versus subjects treated with docetaxel plus raduim-223Secondairy objectives:To compare:a. Radiographic progression free survival as defined in PCWG3 criteria;b.…
To demonstrate that oral anticoagulation with the NOAC edoxaban is superior to current therapy (antiplatelet therapy or no therapy depending on cardio-vascular risk) to prevent stroke, systemic embolism, or cardiovascular death in patients with AHRE…
The primary objective is to evaluate whether the impact of a strategy aimed at switching INR-guided VKA management to a NOAC-based treatment strategy is superior in terms of the occurrence of major or clinically relevant non-major bleeding…