44 results
To evaluate the efficacy of romiplostim for the treatment of thrombocytopenia in subjects with international prognostic scoring system (IPSS) low or intermediate-1 risk MDS as measured by the number of clinically significant bleeding events.
Evaluation the effect of AMG 181 on induction of remission in subjects with moderate to severe UC at week 8 as assessed by a total Mayo Score >= 2 points, with no individual subscore > 1 point.
To evaluate the efficacy of AMG 181 as measured by the proportion of subjects achieving Crohn*s Disease Activity Index (CDAI) remission (CDAI < 150) at week 8.
To evaluate the radiologic progression-free survival (PFS) of subjects treated with the combination of gemcitabine/docetaxel (G/D) plus MORAb-004 versus G/D plus placebo in subjects with metastatic soft tissue sarcoma (mSTS)Secondary Objectives:* To…
Primary objective: to compare changes in endothelial function in patients with obesity related hypertension after 8 weeks of treatment with aliskiren, moxonidine and HCTZ. Secondary objectives: to compare changes in the following parameters in…
The primary objective of this study is:To demonstrate that the percentage of patients who meet the adapted ACR Pediatric 30 criteria at Day 15 is higher with canakinumab compared to placebo.Secondary objectives of this study are:* To evaluate the…
Primary Objective: The primary objective is to evaluate the efficacy of 2 doses ofperampanel (8 and 12 mg) in comparison to placebo given as an adjunctive therapy insubjects with refractory partial seizures.Secondary Objective: The secondary…
The primary objective of this trial is to compare the effect of three different doses of ONO-8539 with placebo in the mean change of the number of micturitions per 24 hrs from baseline to 12 weeks.The secondary objectives of this trial will be:*To…
Primary objective: to compare changes in endothelial function in patients with obesity related hypertension after 8 weeks of treatment with aliskiren, moxonidine and HCTZ.Secondary objectives: to compare changes in the following parameters in…
The purpose of this study is to compare the effect of AT1001 (migalastat hydrochloride) versus placebo on GL-3 in the kidney.
To investigate the effect of suppletion of vitamin D on aspecific musculo-skeletal disorders
SADTo evaluate the safety and tolerability of ascending single doses (SAD) of OCR 002 administered as intravenous (IV) infusions in healthy volunteersTo evaluate the plasma pharmacokinetics (PK) of phenylacetate and ornithine and glutamine after a…
The primary objective of this study is to determine whether reslizumab, at a dosage of 0.3 or 3.0 mg/kg administered once every 4 weeks for a total of 4 doses, is more effective than placebo in improving lung function in patients with eosinophilic…
Primary:* To demonstrate non-inferiority between the level of agreement in diagnosis (i.e. patient classification of normal, mild/moderate or severe ischemic disease based on the number of reversible perfusion segments) between sequential adenosine…
The objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium plus olodaterol fixed dose combination compared with the individual components tiotropium and olodaterol (delivered by…
The primary objective of the trial is to determine the 24-hour FEV1-time profile of tiotropium + olodaterol FDC (2.5/5 µg, 5/5 µg), administered once daily by the RESPIMAT Inhaler, after 6 weeks of treatment.
The primary objective of this study is to compare the effects of orally inhaled tiotropium + olodaterol fixed dose combination (2.5 / 5 µg ; 5 / 5 µg) with tiotropium (5 µg), olodaterol (5 µg) and placebo on lung-hyperinflation and endurance time…
The primary objectives of this study are:Part II: to demonstrate that the time to flare in Part II is higher with canakinumab than with placebo.Part I: to assess if canakinumab allows tapering of steroids as per protocol in at least 25% of…
Primary Objective* To demonstrate the efficacy of adjunctive perampanel therapy, compared to placebo on primary generalized tonic-clonic (PGTC)seizuresSecondary Objectives* To evaluate the safety and tolerability of perampanel in subjects with…
Part 1: To assess the safety, tolerability and pharmacokinetic-dynamic response, of single escalating doses of EA-230 in healthy subjects.Part 2: To assess the dose-and plasma concentration-response relation of single escalating doses EA-230 on…