Study of the impact of indacaterol on the individual lives and health status of patients with chronic obstructive pulmonary disease (COPD) Background and study aims Clinical studies provide useful information regarding both the safety and effectiveness of medicines, but clinical trial settings are not always as close to a real-world sett...

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A study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizures Et tre-armet, randomiseret, dobbeltblindt, placebo-kontrolleret klinisk forsøg til vurdering af effekt og sikkerhed ved to forskellige doser everolimus som supplerende behandling til patienter med Tuberøs Sklerosekompleks med vanskeligt kontrollerbare partielle anfald To compare the reduction in frequency of partial-onset seizures on each of two trough ranges of everolimus (3-7 ng/mL and 9-15 ng/mL) versus placebo in patients with TSC who are taking one to three AE...

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An open label non-randomized extension study to evaluate the safety and tolerability of AIN457 (anti interleukin-17 monoclonal antibody) in patients with psoriatic arthritis To assess the safety and tolerability of AIN457 administered i.v. initially up to 6 months (Part1) with a possible extension of a further 6 months (Part 2 ) in patients with psoriatic arthritis who p...

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Novartis CLBQ707A2101E1 : Essai de phase 1, en escalade de dose déterminant la dose maximum tolérée et la toxicité dose-limitante, chez des patients ayant une tumeur solide. [Informations issues du site clinicaltrials.gov et traduites par l'INCa] [essai clos aux inclusions] Extension to A Phase I Open-Label, Multi-Center Dose-Escalation Study to Determine the Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity of Gimatecan Administered in Two Different Schedules in A...

• Pays France
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• Spécialités Chimiothérapie

Safety, efficacy and PK/PD of QGE031 vs. placebo in patients with active bullous phemphigoid despite oral steroid treatment. Efficacité, sécurité d'emploi et effets pharmacologiques (variation des paramètres sanguins) de QGE031 chez les patients atteints de la Pemphigoïde bulleuse(PB) et ne réagissant pas favorablement au traitement stéroïde oral To demonstrate the efficacy of QGE031 240mg q2w relative to placebo at 12 weeks in patients with BP by reducing disease activity as determined by Clinical Global Assessment of Change (CGA-C) responder...

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An 8-week extension to a randomized, double blind, parallel group, active-controlled, multi-center, 14 week study to evaluate the effectiveness of a valsartan versus an amlodipine treatment stratgey in achieving blood presure control in patients with stage 1 or stage 2 hypertension or uncontrolled on present monotherapy To assess the incremental rate in blood pressure control for those patients on valsartan 320 mg/HCTZ 25 mg and amlodipine 5/10 mg or amlodipine 10 mg/HCTZ 25 mg and valsartan 160/320 mg at (Visit 7, w...

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Study of efficacy and safety of everolimus and letrozole in estrogen receptor positive HER2 negative metastatic or locally advanced breast cancer patients The primary objective is to estimate progression-free survival in patients treated with everolimus + letrozole in the first line metastatic setting.

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A phase II, randomized, double-blind, placebo controlled, multi-center study to evaluate the effects of LCI699 on cortisol in patients with hypertension To determine the maximum tolerated dose (MTD) of LCI699 with respect to cortisol suppression following ACTH stimulation in hypertensive patients

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Phase III study of efficacy and safety in Polycythemia Vera subjects who are restistant or intolerant of hydroxyurea To compare the efficacy of INC424 to Best Available Therapy (BAT) as assessed by both the absence of phlebotomy eligibility and reduction in spleen volume.

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A 12 week treatment, multi-center, randomized, parallel group, double blind, double dummy study to assess the superiority of indacaterol (150 μg o.d.) via a SDDPI in patients with moderate to severe COPD, using salmeterol (50 μg b.i.d.) as an active comparator delivered via a DISKUS inhaler To demonstrate the superiority of indacaterol (150 μg o.d.) versus salmeterol (50 μg b.i.d.) with respect to standardized area under the curve (AUC) for forced expiratory volume in one second (FEV1) b...

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