8 results
There is no formal primary research hypothesis to be statistically tested. The purpose of this study is to evaluate the pharmacokinetics, the pharmacodynamics, the safety profile and tolerability following multiple oral doses of apixaban in…
Primary :To evaluate the prothrombin time (PT) in healthy volunteers treated with edoxaban alone or preceded by apixaban.Secondary : To assess the effect of edoxaban alone or preceded by apixaban on additional pharmacodynamic (PD) assays: activated…
To demonstrate that oral administration of apixaban 2.5 mg BID for 30 days reduces the rate of total venous thromboembolism (VTE) and VTE-related death compared to standard, subcutaneous administration of enoxaparin 40 mg QD for a recommended…
Dual Primary Objectives:* To determine if apixaban is noninferior to VKA (INR target range 2.0-3.0) on the combined endpoint of ISTHmajor or clinically relevant non-major bleeding in patients with NVAF who develop ACS or undergo PCI withplanned…
The primary objective of the study is to descriptively characterize the single-dose and steadystatePharmacokinetics (PK) of diacerein (if quantifiable) and its active metabolite, rhein, after topical application of CCP-020 (diacerein 1% ointment)…
The primary objective of this study is to evaluate the long-term safety and tolerability of Diacerein 1% Ointment for 2 treatment cycles in subjects with EBS that were previously enrolled in studies CCP-020-301 or CCP-020-101.
The aim of this study is to assess whether oral apixaban in non-inferior to the subcutaneous LMWH dalteparin for the treatment of newly diagnosed proximal DVT and/or PE in patients with cancer.
Primary Objectives:• To determine the Recommended Dose of Expanion or the MTD for MP0317 as monotherapy in patients with advanced solid tumors (dose-escalation part only)• To characterize the safety and tolerability of MP0317 as monotherapy in…