77 results
Objectives:Primary:- To evaluate efficacy as measured by overall survival (OS), with a goal of demonstrating the superiority of inotuzumab ozogamicin when administered in combination with rituximab, compared with an active comparator arm.Secondary…
To assess the efficacy of Mirabegron 50mg versus Solifenacin 5mg in the treatment of subjects with OAB who were dissatisfied with their treatment due to lack of efficacy.
descriptive characterisation of the influence of Test or Reference on ovarian activity determined by means of maximum follicular diameter and Hoogland scoredescriptive characterisation of the effect of Test or Reference on endometrial thickness,…
To assess the effect of teriflunomide in comparison to placebo, on frequency of multiple sclerosis (MS) relapses in patients with relapsing forms of MS who are treated with interferon beta (IFN-β)
Primary objective: Study Part 1 : Single Ascending Dose: • To determine the clinical and biological safety and tolerability of oxathridine after an oral increasing single dose administration oxathridine in healthy male subjects. Study Part 2 : Proof…
The purpose of the study is to investigate to what extent WCK 4282 is safe and tolerated. It will also be investigated how quickly and to what extent WCK 4282 is absorbed and eliminated from the body (this is called pharmacokinetics).
To evaluate the safety and tolerability of ascending single and multiple oral doses of ADX71441 as compared to placebo in healthy volunteers.To evaluate the pharmacokinetics of orally administered single and multiple doses of ADX71441 and its…
The objective of this study is to compare the efficacy and safety of the preservative-free fixed-dose combination of tafluprost 0.0015% and timolol 0.5% eye drops to those of tafluprost 0.0015% and timolol 0.5% eye drops given as individual…
Primary Objectives-To compare the efficacy responses of CP-690,550 (5 mg BID and 10 mg BID) versus placebo following 24 weeks of CP-690,550 treatment and subsequent withdrawal of active treatment at various timepoints during the 16-week double-blind…
The primary objective of this study is to evaluate the effect of dalcetrapib on HDL-C levels after 4 weeks of treatment whentreatment is initiated within 1 week after an ACS. The secondary objectives of this study are:- To compare the effect of…
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
To compare the long term efficacy of pasireotide LAR vs. octreotide LAR at month 6 in controlling diarrhea and/or flushing in patients with metastatic carcinoid tumors whose disease-related symptoms are inadequately controlled by the maximum…
The primary objective is to characterize the change in the Pharmacodynamic (PD) biomarker, fecal calprotectin, during treatment with anrukinzumab.The secondary objectives include:* Characterization of the PK profile and total IL-13 of three multiple…
To assess whether a combination of ciprofloxacin and adalimumab is more effective than adalimumab alone.
The purpose of this extension is to provide continued treatment and to assess the long term safety, efficacy and tolerability of oral AEB071 plus Certican® vs. Neoral® plus Certican® in de novo renal transplant recipients. The study is a…
Primary objective(s)• To assess the effects of RLX030 compared to placebo on hemodynamic variables (PCWP, CI) during the first 8 hours administered as i.v. infusion over 20 hours in subjects with Acute Hart FailureSecondary objective(s)• To assess…
The primary objective of the study is to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of 3 intravenous (IV) injections of BG00010 given on 2 fixed schedules; weekly and as frequently as every 48 hours (but no more than 3 times…
Primary objectiveThe primary objective is to evaluate the effectiveness, safety, and tolerability of increasing doses of tapentadol PR (300 mg per day after run in, up titration to 500 mg per day) versus a combination of tapentadol PR (300 mg per…
The goal of this trial is to confirm that eradication rates obtained with Pylera are compatible to those obtained with the current European gols standard, OAC 7 days. This trial will constitute a pivotal trial leading eventually to approval of…
Ibuprofen is a registered drug and belongs to the group of non-steroid inflammation inhibiting drugs. Those drugs inhibit inflammation, are sedative and fever reducing.Ibuprofen is used in pain after dental or mouth chirurgy and after other…