Randomizovaná, multicentrická, dvojitě slepá ověřovací studie k posouzení účinku opakovaných infúzí přípravku AIN457 (10mg/kg) oproti placebu na aktivitu onemocnění měřenou MRI scany po dobu 24. týdnů u pacientů s recidivující-remitující roztroušenou sklerózou To determine the effect of AIN457 (10 mg/kg i.v.) administered week 0, 2, 4, 8, 12, 16 and 20 compared to placebo on the number of combined unique active lesions (CUAL) observed on brain MRI scans per...

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A phase Ib/IIa, trial of LBH589 in combination with trastuzumab in adult female patients with HER2 positive metastatic breast cancer whose disease has progressed during or following therapy with trastuzumab • During dose escalation, to determine the MTD of LBH589 that can be combined with trastuzumab, in patients with HER2-positive MBC whose disease has progressed on or after trastuzumab: Arm 1 - Determi...

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A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303 To evaluate the safety profile of tobramycin inhalation powder after modifications in the manufacturing process (TIPnew) for the treatment of infections with P.aeruginosa in subjects suffering from cy...

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12-month open label, randomized, multicenter study evaluating efficacy, safety and tolerability of oral AEB071 plus tacrolimus (converted to myfortic after 3 months), vs. myfortic plus tacrolimus in de novo renal transplant recipients The primary objective of the study is to demonstrate that in de novo renal transplant patients, at least one of the AEB071 treatment regimens is not inferior to the control treatment (myfortic® + tacr...

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A study evaluating if the addition of MCS110 increases the efficacy of chemotherapy in women with disseminated breast cancer that is not dependent on hormones To assess the anti-tumor activity of MCS110 combined with carboplatin/gemcitabine (carbo/gem) compared to carbo/gem alone.

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A prospective, multicenter, randomized phase III study to evaluate the efficacy of Zometa (zoledronic acid) in delaying progression or recurrence in patients with stage III non-small cell lung cancer The primary objective of the study is to evaluate the efficacy of Zometa in delaying disease progression, disease recurrence or death in patients with locally advanced, stage IIIA and IIIB NSCLC. The ...

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Dose Finding, Safety and Efficacy of Monthly Subcutaneous Canakinumab Administration for the Treatment of Hyperglycemia in Metformin Monotherapy Treated Type 2 Diabetic Patients: a Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study For Period II • To assess safety and tolerability of four doses of ACZ885 (5 mg, 15 mg, 50 mg, and 150 mg) vs. placebo as an add-on regimen over 4 months. • To assess the effect on HbA1c of four doses...

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A multi-centre randomized double blind 12-week study to assess the efficacy, safety and tolerability of QVA149 in patients with COPD who have moderate to severe airflow limitation Multicentrična, randomizirana, dvojno slepa, 12-tedenska študija za oceno učinkovitosti, varnosti in prenosljivosti zdravila QVA149 pri bolnikih s KOPB z zmerno do zelo zmanjšanim pretokom zraka To demonstrate the superiority of QVA149 27.5/12.5 μg b.i.d. compared to monotherapy components, QAB149 27.5 μg b.i.d. and NVA237 12.5 μg b.i.d., in terms of standardized FEV1AUC0-12 at Week 12.

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A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Demonstrate the Effect of 12 Weeks Treatment with Initial Combination of Vildagliptin 100 mg qd plus Metformin 1000 mg bid as compared to Metformin 1000 mg bid in Drug-naïve Patients with Type 2 Diabetes To demonstrate the efficacy of vildagliptin in drug naïve patients with type 2 diabetes by testing the hypothesis that the HbA1c reduction with initial combination of vildagliptin 100 mg qd plus metfo...

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A randomized, double-blind, placebo-controlled, 4 period incomplete block cross-over, multi-center, multiple dose (7 days) dose-ranging study to assess the efficacy and safety of 4 doses of NVA237 in patients with stable Chronic Obstructive Pulmonary Disease (COPD), compared to seven days treatment with tiotropium (18µg once daily, open label) as an active control To evaluate the bronchodilatory efficacy of NVA237 in patients with stable COPD in terms of through FEV1 (mean of 23h 15 min & 23h 45 min post dose) following 7 days of treatment, by comparing four do...

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