International, multicenter, randomized, parallel group, double-blind study, in patients with acute symptomatic deep vein thrombosis of the lower limbs, demonstrating the bioequipotency at steady state of equimolar doses of SSR126517E (3.0 mg) once a week and SR34006 (2.5 mg) once a week, documenting the safety and efficacy of both compounds during a 6-month treatment, and demonstrating the neutralizing effect of SSR29261 on the SSR126517E-induced anti-Xa activity Objetivo principal de la evaluación de bioequipotencia: Demostrar la bioequipotencia de idraparinux biotinilato (SSR126517E) e idraparinux (SR34006) en fase meseta, en pacientes con TVP sintomática a...

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Étude ACT15319 : étude de phase 1-2 randomisée évaluant l’efficacité et la pharmacocinétique de l’isatuximab en association avec du cemiplimab et celles de l’isatuximab seu,l chez des patients ayant un cancer de la prostate métastatique résistant à la castration (mCRPC) ou un cancer du poumon non à petites cellules (NSCLC) de stade avancé. Un cancer de la prostate se développe à partir de cellules de la prostate initialement normales qui se transforment et se multiplient de façon anarchique, jusqu’à former une masse appelée tumeur malig...

• Pays France
• Organes Prostate, Poumon, type non à petites cellules
• Spécialités Immunothérapie - Vaccinothérapie

Immunogenicity and Safety Study of a Hexavalent DTaP-IPV-Hep B-PRP-T Combined Vaccine or Infanrix hexa™ Concomitantly Administered With 13-Valent Pneumococcal Conjugate Vaccine (PCV13), at 3, 5, 11 to 12 Months of Age in Healthy Infants in Europe To demonstrate the non-inferiority of the Hexaxim vaccine to the licensed Infanrix hexa vaccine, both co-administered with Prevenar 13, in terms of seroprotection or vaccine response rates to all anti...

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A double-blind placebo-controlled study of the activity of AVE1625 at doses of 10 mg and 40mg for 12 weeks in patients with mild to moderate Alzheimer's Disease To assess the activity of AVE1625 at the doses of 10 and 40 mg/day in comparison to placebo in patients with mild to moderate Alzheimer Disease: - Safety and tolerability by monitoring of adverse even...

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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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Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation (Intramuscular Route) To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine Northern Hemisphere 2008-2009 formulation with the requirements of the Committee for Human M...

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TDU13828: First-in-human Study with Ascending Single Intra-articular Doses of GZ389988A in Patients with Painful Osteoarthritis of the Knee ACT13830: Proof-of-concept Study to Assess the Efficacy, Tolerability and Safety of a Single Intra-articular Dose of GZ38998A versus Placebo in Patients with Painful Osteoarthritis of the Knee TDU13828: To assess the safety and tolerability of ascending single intra-articular doses of GZ389988A in patients with painful osteoarthritis (OA) of the knee. ACT13830: To assess the efficacy o...

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Estudio de Fase II, aleatorizado, multicéntrico, doble ciego y controlado con placebo, del efecto de SR57667B sobre la función dopaminérgica nigro-estriada, evaluado mediante imágenes PET 18F-Dopa en pacientes ambulatorios con enfermeded de Parkinson temprana Objetivo principal: es estudiar el efecto de SR57667B a la dosis de 4 mg/día sobre la progresión de las lesiones dopaminérgicas nigro-estriadas evaluadas mediante imágenes PET 18F-Dopa.

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Immunogenicity and Safety of the Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2009-2010 Formulation (Intradermal Route) In subjects aged 18 to 59 years for the ID influenza vaccine 9 µg and in subjects aged 60 years or older for the ID influenza vaccine 15 µg: 1) To evaluate compliance, in terms of immunogenicity, of...

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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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