4795 results
The purpose of this current study is to evaluate the efficacy and safety of the 3-day oral aprepitant regimen when administered concomitantly with ondansetron, with or without dexamethasone, in pediatric patients, from 6 months to 17 years of age,…
Is addition of a DPP4-inhibitor (vildagliptin) beneficial in type 2 diabetic patients, starting on once daily long-acting insulin in combination with 2 dd metformin. Primary end point is necessary dose of insulin to remain glycemic control.…
The objective of the trial is to confirm efficacy and a favorable benefit-risk ratio for BIBF 1120 in the treatment of IPF at the dose of 150 mg bid compared to placebo.
Core Study:Primary objective: • To demonstrate that the efficacy of E5501 (in addition to standard of care) is superior to placebo (in addition to standard of care) for the treatment of adult subjects with chronic immune thrombocytopenia (idiopathic…
Primary: Part A:to evaluate the safety and tolerability of single oral ascending doses of VX-787 administered to healthy male and female subjects (of non-childbearing potential)Part C:to evaluate safety and tolerability of multiple oral ascending…
To compare the overall survival of ipilimumab monotherapy at doses of 3 mg/kg versus 10 mg/kg in subjects with previously treated or untreated unresectable Stage III or Stage IV melanoma
Primary Objective:This research study is designed to assess the effectiveness of the combination of study drugs (ASV + DCV) being used to treat the hepatitis C virus (HCV). The best way to assess this aim is to measure the amount of virus in…
In previous studies, the chronic effect, up to 6 months, of the one gastric lead continuous stimulation was demonstrated resulting in an improvement in blood glucose levels. The present hypothesis is that this effect is mediated by either a…
The primary objective of this study is to examine the beneficial effects of nutritional support on the resistance type exercise training-induced changes in body composition and muscle fiber characteristics in healthy young men.
The primary objectives are to:• Compare progression-free survival (PFS) in patients with metastatic or locally advanced (unresectable) chondrosarcoma administered IPI-926 or placebo.• Evaluate the safety of IPI-926 in patients with metastatic or…
The primary objective of the study is to determine if the treatment of AMG 479 at 12 mg/kg and/or 20 mg/kg in combination with gemcitabine improves overall survival as compared with placebo in combination with gemcitabine in subjects with metastatic…
Primary ObjectivesIn patients with primary hypercholesterolemia and high cardiovascular risk with LDL-C >=100 mg/dL (2.59 mmol/L) and <=160 mg/dL (4.14 mmol/L), to evaluate:1)at the end of Phase I, the additional LDL-C percentage…
Primary Objective:• To determine if orteronel plus prednisone improves overall survival (OS)Key Secondary Objectives: • To determine if orteronel plus prednisone improves radiographic progression-free survival (rPFS)• To determine if orteronel plus…
The primary objectives are:- To evaluate the efficacy of IV induction regimens of ustekinumab in inducing clinical response in subjects with moderately to severely active Crohn*s disease who have failed or are intolerant to one or more tumor…
* To investigate the effect of roflumilast 500 µg tablets once daily versus placebo on exacerbation rate, and pulmonary function and major adverse cardiovascular events (MACE) in COPD patients who are concomitantly treated with a fixed combination…
test the hypothesis that the application of PRP leads to faster wound healing, less wound healing disorders, less pain and faster functional recovery after subacromial surgery.
The primary efficacy objective of this study is to evaluate the effect of CCX140-B treatment on urinary albumin excretion in subjects with type 2 diabetes mellitus (T2DM) with albuminuria.The primary safety objective of this study is to evaluate the…
Trafermin spray is a new treatment that is being studied in wound healing and particularly for the treatment of diabetic foot ulcers. When trafermin is sprayed onto a wound, it stimulates the skin and blood vessels to grow again and so speeds up the…
Use of iron chelation therapy has demonstrated benefits in terms of morbidity and mortality for chronically-transfused thalassemia patients with iron overload. Recent retrospective data (Leitch 2007, Rose 2010, Sanz 2008) suggest that overall…
Primary objectives: To evaluate the long-term safety and tolerability of IV administered bapineuzumab in subjects with AD.Secundary objectives: Efficacy. To explore the long-term efficacy of IV administered bapineuzumab in subjects with AD, using…