138 results
The primary objective of this study will be to determine the pharmacokinetic profile of lorazepam oral liquid 1 mg/ml in the paediatric ICU population, with specific attention for the population aged up to 12 years of age.The secondary objectives…
Primary Objective•*To evaluate the relative oral bioavailability of SMV, ODV, and AL-335 when administered as different concept fixed-dose combination (FDC) formulations compared to the single agents when administered together, all under fed…
The primary objective of the study is evaluating the safety, tolerance and anti-lymphoma activity of the anti-CD79b-MMAE conjugate (DCDS4501A) and the anti-CD22-MMAE conjugate (DCDT2980S), both given in combination with Rituximab once every 4 weeks…
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 (…
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 +…
Estimate the maximum tolerated dose (MTD) of AEB071 (dose escalation) and characterize the safety and tolerability of the MTD or recommended Phase 2 dose of AEB071 in patients with DLBCL (dose expansion).
To evaluate the effects of mild, moderate or severe hepatic impairment versus normal hepatic function on the pharmacokinetics of TKI258 in patients with advanced solid tumor
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)…
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 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 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…
Evaluation of intensive therapy for relapsed B-cell lymphoma with CNS localisation. Treatment includes:a. intrathecal administration of rituximab, B. combining R-DHAP with high dose methotrexate intravenously.The following endpoints will be…
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…
The purpose of the study is to investigate whether the cyclodextrin added to the cholecalciferol formulation has an effect on the vitamin D3 availability in the body. Thus, it will be investigated if concentrations of vitamin D3 that are found in…
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 longterm safety and tolerability of oral BAY 63-2521 in patients…
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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 (…
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
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…
To estimate the treatment effect as measured by progression free survival(PFS) of subjects receiving AMG 386 (at 2 doses) in combination with paclitaxel + bevacizumabrelative to paclitaxel + bevacizumab + placebo.