A double-blind, multi-center, randomized withdrawal study evaluating the efficacy and safety of Amibegron 350 mg twice a day versus placebo in the prevention of relapse of anxiety up to 1 year in patients with Generalized Anxiety Disorder improved after 12 weeks of open treatment with Amibegron 350 mg twice a day To assess the efficacy of Amibegron 350 mg twice a day compared to placebo in the prevention of relapse of anxiety, in improved patients with generalized anxiety disorder GAD , over a 24 to 52-week t...

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Long-term safety study in patients included in CLARINET study with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt and for whom the shunt is still in place at one year of age To determine the safety up to 18 months of age of the extended use of 0.2 mg/kg/day clopidogrel in patients who are included in CLARINET study with cyanotic congenital heart disease palliated with a s...

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A randomized, double-blind, placebo-controlled, parallel-group, multicenter, 24-week study followed by an extension assessing the efficacy and safety of AVE0010 in two titration regimens on top of metformin in patients with type 2 diabetes not adequately controlled with metformin The primary objective of this study is to assess the effects of AVE0010 as an add-on treatment to metformin on glycemic control using a two-step dose titration regimen in comparison to placebo in term...

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Randomized phase 2 study of gemcitabine/cisplatin with or without SAR240550 (BSI-201), a PARP1 inhibitor, in patients with stage IV non-small cell lung cancer Studio di fase 2 randomizzato con gemcitabina/cisplatino somministrati da soli o in combinazione a SAR240550 (BSI-201), un PARP-1inibitore, in pazienti affetti da carcinoma polmonare non a piccole cellule in stadio IV Primary objective is to assess the objective response rate (ORR) of SAR240550 administered as a 60-min intravenous infusion twice weekly, when combined to gemcitabine/cisplatin chemotherapy regimen (G...

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Multicenter, randomized, open label study evaluating a poly(ADP-ribose) polymerase-1(PARP-1) inhibitor, SAR240550 (BSI-201), administered twice weekly or weekly, in combination with gemcitabine/carboplatin, in patients with metastatic Triple Negative Breast Cancer (mTNBC)</ To assess the objective response rate (ORR) of SAR240550 administered as a 60min intravenous infusion twice weekly (arm A) or weekly (arm B), in combination with gemcitabine/carboplatin chemotherapy r...

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Double blind placebo controlled dose ranging study of the efficacy and safety of celivarone at 50, 100 or 300 mg OD with Amiodarone as calibrator for the prevention of ICD interventions or death The primary objective of the study is to assess the efficacy of celivarone for the prevention of Implantable Cardioverter Defibrillator (ICD) interventions or death

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