A double-blind, randomized, cross-over, placebocontrolled, 2-part study to compare the effect of exercise and high-dose salbutamol on maximal heart-rate in patients with COPD following therapeutic doses of inhaled QAB149 and salmeterol Primary objective(s) To determine the effect of exercise on maximal heart rate in patients with COPD following therapeutic doses of QAB149 and salmeterol To determine the effect of high-dose ne...

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A twelve-week, randomized, double-blind, multi-center,parallel group, active controlled study to evaluate the efficacy, safety and tolerability of LCZ696 compared to valsartan in patients with chronic heart failure and preserved left-ventricular ejection fraction To demonstrate the efficacy of LCZ696 in patients with chronic heart failure with preserved ejection fraction (HF-PEF) by testing the hypothesis that the reduction in NT-proBNP from baseline to study...

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An extension to a phase II study to determine the safety and the anti- leukemic effects of STI571 in adults patients with Philadelphia chromosome positive leukemia including acute lymphoblastic leukemia, acute myeloid leukemia and accelerate phase myeloid leukemia. Estensione dello studio in aperto di fase II per determinare la tollerabilita` e l`efficacia antileucemica di STI571 in pazienti adulti con leucemia Ph+ incluse la leucemia linfoblastica acuta, la leucemia mieloide acuta e la leucemia mieloide cronica in fase accelerata • To enable patients to have access to study drug and continue study treatment • To decrease data collection to include only overall survival and serious adverse events • Consentire ai pazienti ...

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Alisporivir con pegIFN / RBV in pazienti con epatite C cronica con precedente fallimento terapeutico all'inibitore della proteasi Alisporivir with pegIFN/RBV in protease inhibitor (PI) treatment failure patients with chronic hepatitis C The primary objective is to evaluate the efficacy (SVR12 LOQ) of triple combination therapy of DEB025 400 mg BID and standard dose pegIFN/RBV for 48 weeks in chronic hepatitis C GT 1 patients who fai...

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An open-label, randomized, multicenter, active-controlled, dose-ranging study to evaluate the safety and efficacy of albinterferon alfa-2b administered every 4 weeks plus ribavirin in interferon alfa-naïve patients with genotype 1 chronic hepatitis C To evaluate the safety and tolerability of up to four alb-IFN Q4w regimens (1500 μg, 1800 μg, 2100 μg and 2400 μg) plus daily RBV in IFNα-naïve patients with genotype 1 CHC.

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Studio multicentrico controllato, randomizzato, per gruppi paralleli, per valutare l’efficacia e la tollerabilita' di Myfortic a dose piena, insieme a ciclosporina in microemulsione a dose ridotta, in pazienti con trapianto di rene in fase di mantenimento. Studio MINERVA (Myfortic a dose piena Insieme a Neoral a Esposizione Ridotta: VAlutazione controllata) Confrontare la variazione a 12 mesi della velocita' di filtrazione glomerulare (GFR, calcolata mediante la formula MDRD abbreviata) rispetto al basale (Visita 2), nei pazienti del Gruppo 1 (trattament...

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2-year study of secukinumab treatment in patients with active Ankylosing Spondylitis Studio di 2 anni di trattamento con secukinumab in pazienti con spondilite anchilosante attiva To demonstrate that the efficacy of each secukinumab regimen at Week 16 is superior to placebo in patients with active Ankylosing Spondylitis based on the proportion of patients achieving an ASAS 20...

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OPEN-LABEL TRIAL OF GLIVEC IMATINIB MESYLATE IN PATIENTS WITH REFRACTORY DESMOPLASTIC SMALL ROUND CELL TUMORS DSRCT EXPRESSING A MOLECULAR TARGET OF GLIVEC PDGF-R AND/OR C-KIT

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A randomized, double-blind, placebo-controlled, multicenter phase III study of RAD001 adjuvant therapy in poor risk patients with Diffuse Large B-Cell Lymphoma (DLBCL) of RAD001 versus matching placebo after patients have achieved complete response with first-line rituximabchemotherapy To compare disease-free survival (DFS) in poor risk patients with DLBCL after achieving CR following first-line R-CHOP who receive RAD001 versus patients who receive matching placebo.

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Phase I study to examine the effect of deferasirox on renal hemodynamics in β-thalassemia patients with transfusional iron overload To estimate the effects of deferasirox on changes from baseline in GFR and RPF using 51Cr-EDTA and 123I-Hippuran (I-hip) respectively and the corresponding filtration fraction (FF) in deferasirox na...

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