A phase IIIb, open-label, multi-center 12 month study to evaluate the safety, tolerability and efficacy of ranibizumab (0.3 and/or 0.5 mg) in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration The primary objective of this study is to estimate the incidence of ocular adverse events (AEs) in patients with CNV secondary to AMD who are treated with 0.3 and/or 0.5 mg intravitreal ranibizumab.

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Comparison of long-term safety of the combination product QVA149A against placebo and standard of care treatment in Chronic Obstructive Pulmonary Disease patients with moderate to severe airflow limitation To demonstrate the non-inferiority of QVA149 110/50 μg qd compared to placebo in terms of overall SAE rate from initiation of study treatment through 30 days post last treatment.

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Efficacy, safety and tolerability of the co-administration of NVA237 + indacaterol once daily vs. indacaterol once daily in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) To demonstrate the superiority of NVA237 50 µg + indacaterol 150 µg administered once daily as compared with indacaterol 150 µg administered once daily in terms of trough FEV1 at Week 12.

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Comparison of safety and efficacy of the combination product QVA149A against the concurrent administration of the individual components, QAB149 and NVA237, in patients with chronic obstructive pulmonary disease (COPD) To evaluate the non-inferiority of QVA149 110/50 µg qd as compared to concurrent administration of QAB149 150 µg qd plus NVA237 50 µg qd in terms of its effect on trough FEV1 (mean of 23 h 15 min and ...

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A non-randomized, open-label study to characterize the pharmacokinetics of Glivec/Gleevec® (imatinib mesylate) in pediatric (age range 1 to less than 4 years) patients with chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) or other Glivec/Gleevec® indicated hematological disorders Primary To characterize the pharmacokinetics of imatinib in pediatric patients age 1 to less than 4 years via appropriate integrated PBPK and pop PK approaches

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Randomized Phase III, Double-Blind, Placebo-Controlled Multicenter Trial of Everolimus in Combination with Trastuzumab and Paclitaxel, as First Line Therapy in Women with HER2 Positive Locally Advanced or Metastatic Breast Cancer To compare progression free survival (PFS) between combination treatment of everolimus/ trastuzumab/ paclitaxel and the combination treatment with trastuzumab/paclitaxel.

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Effects of intravenous serelaxin infusion on micro- and macrovascular function in patients with coronary artery disease • To evaluate the effects on the coronary vasculature, as assessed by myocardial perfusion/coronary flow reserve, at the end of treatment (EoT) of 48 hours i.v. administration of 30 μg/kg/24h serelaxi...

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A randomized, double-masked, multicenter, phase II study assessing the safety and efficacy of two concentrations of ranibizumab (intravitreal injections) compared with non-treatment control for the treatment of diabetic macular edema with center involvement The primary objective is to explore whether the activity of ranibizumab (6 and/or 10 mg/ml) treatment is superior to sham treatment in reducing macular edema from baseline to Month 6 in patients diagn...

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A multi-centre randomized double blind 52-week study to assess the safety of QVA149 compared to QAB149 in patients with COPD who have moderate to severe airflow limitation To evaluate the safety and tolerability of QVA149 27.5/12.5 μg b.i.d. and QVA149 27.5/25 μg b.i.d. in terms of adverse event reporting rate in patients with Chronic Obstructive Pulmonary Disease (COPD...

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This is a research study to treat patients who have gout flares with a study medicine called canakinumab or triamcinolone acetonide, that has been previously approved to treat gout flares To confirm that canakinumab 150 mg s.c. administered as pre-filled syringe (PFS) is superior to triamcinolone acetonide 40 mg i.m with respect to patient’s assessment of acute gouty arthritis pain int...

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