58 results
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 main purpose of this study is to assess whether the study drug anetumab ravtansine is more effective than treatment with vinorelbine in patients with stage IV, mesothelin overexpressing malignant pleural mesothelioma. Efficacy will be measured…
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…
Quizartinib selectively inhibits survival pathways that block apoptosis by inhibiting FLT3. Quizartinib inhibits proliferation of FLT3-dependent cell lines, and is effective in human leukemia tumor xenograft models of AML. Data from the Phase 1 and…
BAY 63 2521 is a direct 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 the treatment of…
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…
To assess whether provision of the Red Heart polypill (containing low dose aspirin, a statin and two blood pressure lowering medicines) compared to usual cardiovascular medications improves adherence to indicated medicines and clinical outcomes in…
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 : -…
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 objectives of this study are to compare the safety and efficacy of 2 annual cycles of intravenous (IV) alemtuzumab to 3-times weekly subcutaneous (SC) interferon beta 1a (Rebif*) in patients with active relapsing-remitting multiple sclerosis (…
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To assess the bioequivalence of 6 mg dexamethasone tablet administered PO as an alternative to 5,26 mg dexamethasone-disodiumphosphate (= 4 mg dexamethasone) solution administered IV
The objective is to study the effect of beta-agonist and beta-antagonist treatment on human bone remodeling.
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…
Earlier research nas shown the emerging efficacy and safety profile for INC424, which supports further studies in PV subjects who demonstrate resistance or intolerance to HU therapy [Barosi et al.2009]. This pivotal phase III trial (CINC424B2301) is…
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.…
The objectives of this study are to examine: (1) the long-term safety and efficacy of alemtuzumab in multiple sclerosis (MS) patients who received alemtuzumab during prior Genzyme-sponsored studies including CAMMS223, CAMMS323, or CAMMS32400507 (…