135 results
As results from a recently completed radio-labeled human ADME study [CLBH589B2108] in patients indicated that both kidney and liver are involved in the elimination and metabolism of panobinostat, understanding the impact of altered organ function…
Compare efficacy and safety ofpomalidomide versus placebo in reversing RBC-transfusiondependence in subjects with MPN-associated myelofibrosis and RBC-transfusion-dependence. Investigate variables correlated with RBC-transfusion-independence and/or…
The primary objective is:To evaluate the efficacy of pomalidomide (CC-4047) monotherapy in subjects with refractory orrelapsed and refractory multiple myeloma who discontinued treatment after being treated withdexamethasone alone (Treatment Arm B)…
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…
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.…
* to describe the safety profile for qW, q2W and q3W regimens. * to determine the Maximum Tolerated Dose (MTD), if achieved (all regimens)* to describe the pharmacokinetics (PK) of single-agent RO6895882. Substudy BP28920/IMGThe study is designed to…
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 (…
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 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…
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…
CAEB071A2206 will assess safety, efficacy and target trough levels for optimal dosing of AEB071 combined with Certican in a CNI-free regimen in de novo renal transplant recipients. This study will combine the investigational drug AEB071 with an…
To assess non-inferiority of a regimen containing ritonavir-boosted elvitegravir versusraltegravir, each administered with a background regimen in HIV-1 infected,antiretroviral treatment-experienced adult subjects as determined by the proportion…
Primary: To assess the effects of PRM-151 compared to placebo on the success of trabeculectomy by reducing post-surgical scarring in glaucoma patients who have undergone primary trabeculectomy, evaluated at day 120.Secondary: To assess the safety…
Primary: To demonstrate the superior efficacy (composite of all-cause death + Myocardial infarction) of otamixaban to unfractionated heparin (UFH) + eptifibatideSecondary:• To demonstrate the superior efficacy ( composite of all-cause death +…
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…
Primary objective:Phase 1b:-To evaluate the safety and tolerability of escalating doses of mapatumumab in combination with cisplatin and radiotherapy in subjects with locally advanced cervical cancer.Phase 2:-To evaluate the efficacy of mapatumumab…
Pertuzumab is an investigational agent being studied for the treatment of HER2-positive gastric cancer. This study intends to provide a dose of pertuzumab to find an acceptable minimum pertuzumabconcentratie pertuzumab effective when administered in…
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…