Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients with Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and are Treated with Insulin (ODYSSEY DM - Insulin) To demonstrate the superiority of alirocumab in comparison with placebo in the reduction of calculated low-density lipoprotein cholesterol (LDL-C) in patients with diabetes treated with insulin and wi...

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Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients with Severe Hypercholesterolemia Not Adequately Controlled with Conventional Lipid-modifying Therapies To provide patients with severe hypercholesterolemia at risk for subsequent cardiovascular (CV) events and not adequately controlled with currently available lipid-modifying therapy (LMT) access to al...

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A multicenter, randomized, double blind, placebo controlled Phase III study to assess the efficacy of xaliproden in patients with oxaliplatin-induced peripheral sensory neuropathy (PSN) following adjuvant chemotherapy for colon cancer To assess the effect of xaliproden hydrochloride (xaliproden) 1 mg per oral daily on the rate of complete resolution of PSN at 6 months, following randomization, after the completion of oxaliplatin-ba...

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A Study to Compare Pharmacodynamics and Pharmacokinetics of Insulin Glargine 300 U/mL (Toujeo®) to Insulin Degludec (Tresiba®) Under Steady State in Subjects with Type 1 Diabetes Mellitus (T1DM) To compare the pharmacodynamic profile of Toujeo with Tresiba in steady state in a euglycemic clamp after 8 days once daily dosing regimen at 2 dose levels in T1DM patients

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Randomized comparison of a two-month regimen of irbesartan versus enalapril on cardiovascular markers in patients with acute coronary syndrome without ST segment elevation The main objective of this study is to assess if a two-month regimen of irbesartan in patients hospitalized for acute coronary syndrome without ST segment elevation can reduce inflammation markers (ie...

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Estudio randomizado de fase II de Docetaxel en combinación con Oxaliplatino con o sin 5-FU o Capecitabina, en cáncer gástrico metastásico o en recurrencia local que no haya sido tratado previamente para la enfermedad avanzada con quimioterapia Evaluar el tiempo hasta la progresión (TTP) de docetaxel en combinación con oxaliplatino con o sin 5-FU o capecitabina en cáncer gástrico metastásico o con recurrencia local que no ha sido tratado pre...

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Study of Aflibercept as Maintenance Following Induction of Aflibercept in Combination with XELOX, as First-Line Treatment for Metastatic Colorectal Cancer Patient Studio con aflibercept come terapia di mantenimento dopo induzione con aflibercept in combinazione con XELOX, come prima linea di trattamento in pazienti affetti da tumore del colon-retto metastatico Study Part 1: To determine the recommended dose for the aflibercept, oxaliplatin and capecitabine (XELOX) combination to be used in the Part 2 of the study Study Part 2: To assess the percentage of ...

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Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients with Type 2 Diabetes and Mixed Dyslipidemia (ODYSSEY DM-Dyslipidemia) To demonstrate the superiority of alirocumab in comparison with usual care in the reduction of non-high-density lipoprotein cholesterol (non-HDL-C) in patients with type 2 diabetes and mixed dyslipide...

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Superiority study of insulin glargine over sitagliptin in insulin-naïve patients with type 2 diabetes treated with metformin and not adequately controlled The primary objective of this study is to demonstrate the superiority of insulin glargine over sitagliptin in reducing HbA1c from baseline to the end of the treatment period.

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Superiority of insulin glargine Lantus vs. NPH: “Treat to Normoglycemia concept”. Effect of Insulin Glargine in Comparison to Insulin NPH in Insulin-naïve People with Type 2 Diabetes Mellitus Treated with at Least One OAD and Not Adequately Controlled Primary: To demonstrate the superiority of insulin glargine over insulin NPH on the change in HbA1c from baseline to the end of the treatment period.

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