Pivotal phase III trial to investigate the efficacy and safety of an Orodispersible Tablet vardenafil versus placebo in the treatment of men with Erectile dysfunction (ED) - a fixed-dose, double-blind, raNdomized multi-center Trial - POTENT I The primary objective of this study is to compare the efficacy and safety of vardenafil ODT 10 mg (PRN) after 12 weeks of treatment or LOCF with placebo in a general population of men with erectile dy...

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Estudio de fase II, aleatorizado, doble ciego, para evaluar la eficacia y la seguridad de sorafenib comparado con placebo en pacientes con cáncer epitelial de ovario o con cáncer peritoneal primario que han alcanzado una respuesta clínica completa después de quimioterapia estándar con platino/taxano. (A Double-Blind, Randomized Phase II Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Ovarian Epithelial Cancer or Primary Peritoneal Cancer Patients who have achieved a Complete Clinical Response after Standard Platinum/Taxane Containing Chemotherapy) The objective of this study is to evaluate the efficacy and safety of sorafenib compared to placebo in Ovarian Epithelial Cancer or Primary Peritoneal Cancer patients who have achieved a complete clin...

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A Phase II randomized, double-blind, placebo-controlled study of sorafenib or placebo in combination with transarterial chemoembolisation (TACE) performed with DC Bead and doxorubicin for intermediate stage hepatocellular carcinoma (HCC) To demonstrate the superiority of sorafenib over placebo with regard to Time To Progression (TTP) in patients with intermediate stage HCC receiving TACE performed with DC Bead

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A Phase III Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients with Stage IIIb with effusion and stage IV Non-Small Cell Lung Cancer (NSCLC) The objectives of this phase III study are to compare the efficacy and safety of sorafenib in combination with gemcitabine and cisplatin versus placebo with gemcitabine and cisplatin for first-line tr...

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Programa de extensión a largo plazo con sorafenib Sorafenib Long Term Extension Program (STEP) El objetivo principal del programa es permitir que los pacientes que actualmente reciben monoterapia con sorafenib (Nexavar®) en un ensayo clínico patrocinado por Bayer/Onyx puedan continuar el tratam...

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Phase II study comparing sorafenib to placebo when administered in combination with chemotherapy for the treatment of metastatic colorectal cancer in Subjects Who Have Not Been Previously Treated for Stage IV Disease The objective of this phase 2 study is to evaluate the antitumor activity, safety, and tolerability of sorafenib versus placebo when used in combination with mFOLFOX6 (5-fluorouracil [5-FU], levo-leuc...

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