A double-blind, randomized, multicenter, placebo-controlled phase 3 trial to prove the superiority of bifonazole vs. placebo after 4 weeks of onychomycosis treatment (as a follow-up of a 2 weeks treatment of non-surgical nail ablation of diseased nail matrix with a 40% urea paste) The primary objective of the trial is to demonstrate superiority of bifonazole vs. placebo after 28 days of onychomycosis treatment as a follow-up of non-surgical nail ablation with a 40% urea paste o...

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A Placebo Controlled, Randomized, Double-Blind, Fixed-dose, Multicenter, Phase IIb Study to Investigate the Efficacy and Tolerability of BAY 58-2667 (150 µg/h, 100 µg/h, 50 µg/h) Given Intravenously to Subjects with Acute Decompensated Chronic Congestive Heart Failure (ADHF) The primary objective of this study is to investigate the safety and efficacy of a fixed dose (150 µg/h, 100 µg/h, or 50 µg/h) over at least 24 hours and up to 48 hours of intravenous BAY 58-2667 in s...

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Contrast-Enhanced MRI of the renal arteries The primary objective of this study is to evaluate the efficacy of gadobutrol-enhanced MRA over 2D-ToF MRA in subjects with known or suspected renal artery disease, as verified by - superiority for ...

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Maintenance treatment of anemia in pre-dialysis subjects with chronic kidney disease on darbepoetin treatment versus BAY 85-3934 To evaluate the efficacy of 16 weeks of titrated dose treatment with BAY 85 3934 versus darbepoetin alfa (hereafter called darbepoetin) as measured by haemoglobin (Hb) levels during the last 4 weeks o...

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A multicenter, open, randomized, parallel-group comparison to assess the safety and efficacy of the oral contraceptive SH T 00186 D (0.02 mg ethinylestradiol as betadex clathrate and 3 mg drospirenone) in two variations of an extended regimen vs. a standard regimen (24 + 4 days) in 1122 healthy female volunteers for one year, followed by a 1-year safety extension To evaluate the safety and efficacy of 2 variations of an extended regimen of the oral contraceptive SH T 00186 D (0.02 mg EE as ß-CDC and 3 mg DRSP) compared to the standard 24 + 4-day regimen of th...

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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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Étude 16790 : étude de phase 1, évaluant la pharmacodynamique du copanlisib (BAY 80-6946) administré seul, chez des patients ayant un lymphome non hodgkinien ou une tumeur solide avancée et/ou en rechute. [essai clos aux inclusions] L’objectif de cette étude est d’évaluer la pharmacodynamique du copanlisib (BAY 80-6946) administré seul, chez des patients ayant un lymphome non hodgkinien ou une tumeur solide. Les patients seront ...

• Pays France
• Organes Lymphomes non hodgkinien, Tumeurs solides
• Spécialités Thérapies Ciblées

Phase II PI3K inhibitor in relapsed, indolent or aggressive NHL The objective of this study is to evaluate the efficacy and safety of copanlisib in patients with indolent or aggressive Non-Hodgkin’s Lymphoma (NHL) who have progressed after standard therapy. Th...

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Étude 18326 : étude de phase 1b évaluant la sécurité et la tolérance de l’anétumab ravtansine en association avec la doxorubicine liposomale pégylée chez des patientes ayant un cancer de l’ovaire, de la trompe de Fallope ou un cancer primitif du péritoine récidivant, exprimant la mésothéline et résistant au platine. Le cancer du péritoine résulte le plus souvent de la multiplication, au niveau de la cavité du péritoine, de cellules cancéreuses provenant de l’un des organes de l’abdomen. Chez la femme, ce type de ...

• Pays France
• Organes Ovaire, Appareil génital féminin - autres, Péritoine
• Spécialités Immunothérapie - Vaccinothérapie, Chimiothérapie