103 results
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…
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To determine if the addition of midostaurin to daunorubicin/ cytarabine induction, high dose cytarabine consolidation, and continuation therapy improves overall survival (OS) in both the mutant FLT3-ITD and FLT-3 TKD AML patients.
The primary objective of this trial will be to evaluate the effect of ONO-2506PO (1200 mg once daily) on the slope of respiratory function (slow vital capacity (SVC) expressed as a percentage of the predicted value) over 12 months compared with…
To determine the feasibility, toxicity and safety of anti-CEA x anti hapten bispecific antibodies (TF2) and Lu-177-labelled di-HSG-DOTA peptide (IMP-288) in patients with advanced colorectal carcinoma.
The primary objective of this study is to evaluate the effects of SYR-322 and SYR-322coadministered with pioglitazone HC1 versus placebo on postprandial triglycerides in subjectswith type 2 diabetes.
The primary objective is to evaluate the safety and tolerability of perampanel (up to12mg/day) given as adjunctive treatment in subjects with refractory partial seizuresThe secondary objective is to evaluate the maintenance of effect of perampanel…
Clinical trial to investigate a difference in effectiveness for the treatment of intertrigo in wich the combination of zinc oxide 10% in ketoconazole will to be compared with zinc oxide 10% and hydrocortisone-acetaat 1% in ketoconazole.
To evaluate the efficacy of ACZ885 plus MTX by assessing the response to treatment (ACR50) as compared to MTX alone in early RA patients after 6, 14 and 26 weeks of treatment. The study aims to evaluate the clinical response in this RA subpopulation…
To evaluate the safety (bleeding) of 4 doses of apixaban as compared to placebo over a 26 week treatment period in selected subjects with recent (<=7 days) Acute Coronary Syndrome (ACS). To determine the optimal dose and regimen of apixaban…
To demonstrate that oral apixaban 2.5 mg BID is superior to subcutaneous (SC)enoxaparin 40 mg QD in reducing the event rate on the composite endpoint of adjudicated asymptomatic and symptomatic DVT, non-fatal PE and all-cause death through Day 12 of…
To evaluate the efficacy of BRV at the doses of 20, 50 and 100 mg/day in b.i.d. administration in reducing seizure frequency in subjects with partial onset seizures not fully controlled despite optimal treatment with 1 to 2 concomitant AED(s),…
North America, Europe, and rest of worldThe primary objective of this study is to determine whether BG00012, when compared with placebo, is effective in reducing the proportion of relapsing subjects at 2 years.The secondary objectives of this study…
The primary objective for part I of the study is the investigation of the pharmacokinetics. Although there is substantial clinical experience with all components of HTX-011, the formulation itself and the route of administration is new, which…
To demonstrate the efficacy of ponatinib administered at 2 starting doses (30 and 15 mg QD) compared to nilotinib administered at 400 mg BID in patients with CP-CML who are resistant to imatinib, as measured by MMR by 12 months
Primary Objective:To characterize the efficacy of ponatinib administered in 3 starting doses (45 mg, 30 mg, and 15 mg daily) in patients with CP-CML who are resistant to at least 2 TKIs, as measured by MCyR by 12 months.Key Secondary Objectives:* To…
Primary ObjectivesTo determine the pharmacodynamic effect of linsitinib in the tumourTo evaluate the safety and tolerability of linsitinibSecondary ObjectivesTo determine the clinical outcomeTo conduct pharmacokinetic assays with linsitinib…
Primary:* To assess the effect of vedolizumab SC maintenance treatment on clinical remission at Week 52 in subjects with moderately to severely active UC who achieved clinical response at Week 6 following administration of vedolizumab IV at Weeks 0…
* To determine the DLT and the MTD/RP2D of docetaxel as ModraDoc006/ritonavir that can be administered safely to patients with NSCLC in a bi-daily weekly schedule, following platinum doublet first-line treatment.