152 results
Primary: To evaluate the long-term safety and tolerability of BIIB017 in subjects originally treated in Study 105MS301 who continue BIIB017 treatment.Secondary: To describe long-term MS outcomes in subjects originally treated in Study 105MS301 who…
To investigate both the clinical and economical(-healthcare evaluation) improvement of BVR using best responder criteria in patients with severe COPD.
To determine if HF subjects whose treatment is assisted by a daily BNP measurement that is integrated into a home health management system will have improved clinical outcomes versus subjects whose treatment includes home health management but is…
Primary:The primary objective of the study is to evaluate the efficacy of oral administration of dexpramipexole 150 mg twice daily compared to placebo for 12 months in subjects with ALS.Secondary:The secondary objectives of the study are to evaluate…
To ascertain whether the survival time distribution for patients randomized to the investigational arm is consistent with longer survival as compared to patients randomized to the control arm.
To evaluate the long-term safety, tolerability and efficacy of ArikaceTM 590 mg for a maximum 12 cycles administered once daily, where each cycle consists of 28 days on treatment followed by 28 days off treatment.
Primary objective: Safety.Secondary objective: Efficacy.
In this study we will compare the effect of intra nodal allegen injection with grass pollen to the intra nodal injection with placebo on symptome scores of allgic rhinitis (hay fever) in grass allergic patients.
Primary Study Objective:To assess the efficacy and safety of the co-administration of low-dose pegvisomant (40 mg, administered via subcutaneous injection given once a week) and long-acting somatostatin analogs (administered once monthly) on the…
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.- To evaluate the safety of IV induction regimens of…
1. To compare cartilage changes after KJD and after HTO, based on MRI, radiographs and biomarkers, evaluated 2 years post treatment. 2. To compare clinical efficacy after KJD and after HTO during 2 year follow-up by a questionnaire (KOOS; for pain,…
A previous study of from our laboratory showed that administration of the drug C1-INH (100E/kg) significantly reduced the concentration of circulating pro-inflammatory cytokines, such as IL-6, in healthy male volunteers during human experimental…
The primary objective of the METFORMIN study is to determine the efficacy of metformin in combination with lifestyle-intervention in obese children and adolescents with insulin resistance versus placebo with lifestyle-intervention. The secondary…
The primary objective is to evaluate the antiviral efficacy of TMC435 in combination with PegIFN*-2a and RBV.In addition to this, the study provides access to TMC435 treatment in combination with PegIFN/RBV to (1) subjects whoparticipated in the…
Primary Objective: To evaluate the immunogenicity of N9-GPKey Secondary Objectives:* To evaluate clinical efficacy of haemostasis (treatment of bleeding episodes) of N9-GP* To evaluate clinical efficacy of N9-GP in long term bleeding prophylaxis (…
PrimaryObjectives: 1. Evaluate the efficacy of adding anacetrapib 100 mg for 52 weeks relative to placebo on plasma concentrations of LDL-C. 2. Evaluate the safety and tolerability of 52 weeks of treatment with anacetrapib 100 mg.Hypotheses: 1.…
To assess safety and tolerability of EFI patients with PAH.
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)…
Primary objective: efficacy of the C-seal in reducing anastomotic leakage (AL).Secondary objectives: The number of dismantled anastomoses; AL within 30 days according to the ISGRC classification; interval between the operation and AL; The pain score…
The purpose of the multicenter, randomized, open-label, parallel-group study EFC11628 is to compare the efficacy and safety of HOE901-U300 with that of Lantus®, both given once-daily s.c. as part of a basal-bolus insulin regimen in patients with…