56 results
1. The primary efficacy objective is to evaluate whether rivaroxaban, in doses of 10 mg or 20 mg, is superior to ASA 100 mg in the prevention of the primary efficacy outcome (i.e. fatal or non-fatal symptomatic recurrent venous thromboembolism).2.…
EFFICACY OBJECTIVESThe primary efficacy objective of this study is to evaluate the efficacy of intravitreal injections of 10 mg lampalizumab administered Q4W or Q6W in CFI profile biomarker positive and CFI profile biomarker-negative patients…
Primary Objective:To evaluate the efficacy of ASP8232 in reducing Urinary Albumin Creatinine Ratio (UACR) in subjects with Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD) at 12 weeks compared to placebo.Secundary Objectives:1. To…
The first objective is to evaluate the superiority of CHF 5259 pMDI (glycopyrrolate bromide) (50 µg total daily dose) versus placebo in terms of FEV1 AUC0-12h normalised by time on Day 42.Key Secondary objectiveTo evaluate the superiority of CHF…
EFFICACY OBJECTIVESThe primary efficacy objective for this study is to evaluate the efficacy of lebrikizumabused as adjunctive therapy with TCS compared with TCS in patients with persistentmoderate to severe AD, as measured by Eczema Area and…
PRIMARY OBJECTIVES * To evaluate the efficacy of lebrikizumab compared with placebo as measured by theability of patients to achieve lower daily doses of OCS while maintaining control oftheir asthma* To evaluate periostin as a predictive biomarker…
Given the medical need for improved treatment strategies for patients with previously treated and relapsed MM, the purpose of this phase III study is to compare treatment with bortezomib/dexamethasone + panobinostat to bortezomib/dexamethasone +…
To investigate in a randomized controlled trial, whether giving Cofact pre-operatively can reduce the bloodloss and transfusion requirements during orthotopic liver transplantation. Also we investigate the safety of Cofact in this patient population…
Primary:* To evalaute the efficacy of three doses of norUDCA vs. placebo for the treatment of PSC* To identify efficacious norUDCA dose(s) for the treatment of PSC for further evaluation in phase III. Secondary:* To study safety and tolerability (…
The primary objective of this study is to : Assess the hemodynamic profile of Riociguat in patients with symptomatic pulmonary hypertension associated with left ventricular systolic dysfunction The secondary objectives of this study are to : -…
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
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To compare the combination treatment of everolimus and exemestane to exemestane alone with respect to progression-free survival in postmenopausal women with estrogen receptor positive breast cancer that is refractory to non-steroidal aromatase…
Primary objective: To determine if apixaban is noninferior to warfarin (INR target range 2.0-3.0) in the combined endpoint of stroke (ischemic or hemorrhagic) and systemic embolism, in subjects with AF and at lease one additional risk factor for…
Primary Objective1. The main objective of this study is to demonstrate that OM/AML/HCTZ triple combinations are more efficacious in lowering SeDBP than corresponding dual combinations of OM/AML after 10 weeks of double blind treatment.Secondary…
BAY 63 2521 is a stimulator of the soluble guanylate cyclase (sGC) and is intended for the treatment of cardiovascular diseases, especially pulmonary hypertension (PH).To assess the efficacy and safety of oral BAY 63 2521 in patients with inoperable…
The primary objective is to compare the overall survival (OS) of patients receiving ASA404 or placebo in combination with paclitaxel and carboplatin for first-line treatment of stage IIIb/IV NSCLC
The primary objective of the study is to evaluate the efficacy of desmoteplase 90µg/kg versus placebo in terms of favourable outcome at Day 90 in subjects with acute ischemic stroke. Secondary objectives are to evaluate: the efficacy of desmoteplase…
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…
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…