A randomized, double masked, active controlled, phase 3 study of the efficacy, safety, and tolerability of repeated doses of intravitrial VEGF Trap-Eye in subjects with neovascular age-related macular degeneration (AMD) To assess the efficacy of intravitreally (ITV) administered VEGF Trap-Eye compared to ranibizumab (in a non-inferiority paradigm) in preventing moderate vision loss in subjects with all subtypes of ne...

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New title: Prospective, multicenter, randomized, independent-group, open-label phase II study to investigate the efficacy, safety and tolerability of 4 regimens with 3 doses of ZK 219477 (16 and 12 mg/m² body surface area as 3-hour infusion or 22 mg/m² body surface area as 30-minute or 3-hour infusion) in patients with metastatic breast cancer. (Old title before amendment:Prospective, multicenter, randomized, parallel-group, open-label phase II study to investigate the efficacy, safety and tolerability of 2 doses of ZK 219477 (16 and 12 mg/m² body surface area) in patients with metastatic breast cancer.) To investigate the efficacy of 4 regimens with 3 doses of ZK 219477 in patients with metastatic breast cancer in progression following a maximum of 2 previous regimen of chemotherapy. Previous chemot...

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A double-blind, randomized, placebo and active controlled, multicenter study to investigate efficacy and safety after oral administration of 2 and 3 mg ZK 283197, 1 mg 17ß-estradiol and placebo once daily for 8 weeks in postmenopausal women with hot flushes To investigate the influence of a 8-weeks multiple dose treatment with two oral doses of ZK 283197 in comparison to E2 and placebo on the reduction of moderate to severe hot flushes

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(REASON) double-blind, Randomized phase II study to Evaluate the safety and efficacy of Acetyl-l-carnitine in the prevention of SagOpilone-induced peripheral Neuropathy Primary Objective: to demonstrate the superiority of ALC over placebo in the prevention of Sagopilone-induced peripheral neuropathy

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Multi-center, double-blind, placebo-controlled study to investigate the efficacy and safety of daily oral 100 mg dehydroepiandrosterone (DHEA) over 6 treatment cycles as a concomitant therapy to oral contraceptives (OC) to alleviate complaints of reduced libido in women with acquired female sexual dysfunction (FSD) associated with OC-use To investigate the effects of 100 mg DHEA per day in women on continuous treatment with a monophasic combined oral contraceptive (COC) who suffer from an acquired OC-associated HSDD as a perceived adv...

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Monocenter, open-label, randomized study to determine the ovulation inhibitory effect of the combined oral contraceptives SH T04769G (0.015 mg Ethinylestradiol and 1.5 mg Dienogest in a modified release medicinal product) and SH D00659AF (0.03 mg Ethinylestradiol and 2.0 mg Dienogest), applied for two treatment cycles to 60 healthy female volunteers The aim of the study is to determine the ovulation inhibitory effect of the COC SH T04769G (0.015 mg Ethinylestradiol and 1.5 mg Dienogest in a modified release film-coated tablet) and to collect sup...

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Estudio abierto, multicéntrico, en fase III, con lectura ciega de imágenes, para evaluar la eficacia y la seguridad de una única inyección intravenosa de 0,1 mmol / kg de peso corporal de gadobutrol 1,0 molar (Gadovist®) en pacientes con diagnóstico reciente de cáncer de mama referidos para resonancia magnética de mama, realzada con contraste An open label, multi-center, phase 3 study with corresponding blinded image reading to determine the efficacy and safety of a single intravenous injection of 0.1 mmol/kg body weight of gadobutrol 1.0 molar (Gadovist®) in patients with newly diagnosed breast cancer referred for contrast-enhanced breast MRI 1. La superioridad de la MRM combinada sin realzar y realzada con gadobutrol frente a la MRM sin realzar. 2. La superioridad de la MRM combinada sin realzar y realzada con gadobutrol más MRX frente a ...

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Investigation of the effects of postprandial glucose reduction by acarbose on insulin sensitivity and cardio-vascular markers in the subjects with different stages of glucose tolerance Not provided at time of registration

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International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved To increase the knowledge on the safety and tolerability profile of the IFNB-1b 500 µg dose

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A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically-Ventilated Patients with Gram-Negative Pneumonia To evaluate the efficacy (superiority) and safety of BAY 41-6551 as measured by the comparison of the clinical cure rate of aerosolized BAY 41-6551, administered via the PDDS Clinical, versus placebo ...

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