84 results
Run-in phase I: To confirm the safety and tolerability of BIBF 1120 up to a dose level of 200 mg b.i.d added to a standard dose of cisplatin/gemcitabine in first line NSCLC patients with squamous cell histology. Pharmacokinetics of BIBF 1120 and…
The primary objective of this phase III study is to demonstrate that lixisenatide can reduce cardiovascularmorbidity and mortality (composite endpoint of cardiovascular (CV) death, non-fatal myocardialinfarction (MI), non-fatal stroke,…
Primary Objectives:1. To evaluate the efficacy of anacetrapib 100 mg for 24 weeks relative to placeboon plasma concentrations of LDL-C (BQ method).2. To evaluate the efficacy of anacetrapib 100 mg for 24 weeks relative to placeboon plasma…
The purpose of this study in patients with primary progressive multiple sclerosis (PPMS) is to evaluatewhether FTY720 is effective in delaying MS disability progression in the absence of relapsescompared to placebo. Furthermore, safety and…
The primary objective of the study is to evaluate the safety and efficacy of inactivated VZV vaccine for the prevention of HZ and HZ-related complications in adult recipients of autologous hemotopoietic cell transplants (HCTs).
The aim of the study is to confirm efficacy and safety of treatment with 600 mg of BID BI207127 in combination with 120 mg QD Faldaprevir and RBV for 16 and 24 weeks in target chronically infected HCV GT1b treatment naïve patients, including a…
• To evaluate the safety of up to 3 additional courses of oral QLT091001 administered once daily for 7 days in subjects with LCA or RP caused by RPE65 or LRAT gene mutations who have been treated previously with a single 7-day course of QLT091001 in…
The objective of the trial is to assess the safety and tolerability of i.c.v. administration of sNN0029 infusion solution at a dose of 4 µg per day delivered via a Medtronic SynchroMed® II Infusion System.
• To evaluate the effect of olaparib on exposure to anastrozole by determination of steady-state exposure to anastrozole in the presence and absence of steady-state exposure to olaparib• To evaluate the effect of anastrozole on exposure to olaparib…
This is an open label proof of principle study, in 14 patients. The objective of the study is to test the efficacy and safety of ARA 290 in patients with active rheumatoid arthritis. To assess the efficacy, disease activity is examined based on…
The primary objective of the study is to compare the efficacy of intravenous immunoglobulin product with the efficacy of antibiotic treatment in patients with recurrent respiratory infections and IgG-subclass deficiency and/or selective anti-…
Primary: To assess the effect of UT-15C sustained release (SR) on exercise capacity compared to placebo (as measured by the change in 6-Minute Walk distance from Baseline to Week 12) in subjects with PAH who are not currently receiving ERA, PDE-5…
The aim of this Phase II proof of concept study is to assess efficacy, haemodynamics and safety of Terguride vs. placebo in patients with pulmonary arterial hypertension (PAH). Having finished this proof-of-concept study it is intended that patients…
The primary objective of the study is to assess the safety and immunogenicity of V212 in a population of adults with autoimmune disease.
Primary objectiveTo evaluate if BRV influences the psychomotor and cognitive impairing effects of ethanolSecondary objectivesTo evaluate the potential PK interactions between BRV and ethanolTo evaluate the safety and tolerability of co-…
This study will evaluate the efficacy and safety of 2.0 mg/kg/week and 2.0 mg/kg/every other week BMN 110 in patients with mucopolysaccharidosis IVA (Morquio A Syndrome). This study will compare the effects of 24 weeks of infusions of BMN 110 at…
To evaluate the long-term safety and efficacy of BMN 110 administration at 2.0 mg/kg/qw and 2.0 mg/kg/qow in patients with MPS IVA.
Primary Objective:To assess the ability of BR55 to identify area(s) of VEGFR2 expression in human prostate by ultrasound molecular imaging on the basis of a visual score in comparison with histopathology analysis (location based on expression of…
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• Test the safety of the research drug, telcagepant (MK-0974)• Test the safety of the research study drug telcagepant (MK-0974) in the prevention of menstrually related migraines. • Compare the effectiveness of the research study drug telcagepant (…