An open phase III trial with Letrozole (Femara®) alone or in combination with Zoledronic acid (Zometa®) as extended adjuvant treatment of postmenopausal patients with primary breast cancer It is the aim of this study to show superiority of Zoledronic acid in prevention of bone loss, administered in combination with Letrozole as extended adjuvant therapy of postmenopausal women with prim...

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Comparison of systemic VEGF protein dynamics following monthly intravitreal injections of 0.5 mg ranibizumab versus 2 mg aflibercept in patients with neovascular (wet) age-related macular degeneration The primary objective of this study is to compare systemic VEGF-A protein levels following monthly intravitreal injections of 0.5 mg ranibizumab versus 2 mg aflibercept as measured by the area under t...

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Study investigating a standard treatment in kidney transplant patients versus a treatment with Certican® in combination with Cyclosporin A or Tacrolimus To demonstrate non-inferiority in renal function assessed by glomerular filtration rate (Nankivell formula) in at least one of the Certican® treatment regimens compared to the standard group at month ...

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Influence of Zoledronic acid (Zometa®) on bone mineral density and bone ultrasonometry in premenopausal women with hormone receptor negative breast cancer and adjuvant chemotherapeutic treatment This study is designed to demonstrate superiority of Zometa® (Zoledronic acid) 4 mg or adjusted dose based on renal function, given every 3 months over 24 months (infusion at month 0, 3, 6, 9, 12, 15,...

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A 6-month, multicenter, randomized, controlled parallel group study to evaluate the effect of physical training on fatigue in patients with relapsing-remitting multiple sclerosis treated with fingolimod (Gilenya®), followed by a 6 month optional extension phase To evaluate the effect of structured physical e-training vs. no training on fatigue in Gilenya-treated RRMS patients after 6 months; assessed by the mFIS fatigue scale.

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Evaluation of evolution of renal function in maintenance liver transplant recipients receiving either RAD001 (everolimus) plus reduced TAC or RAD001 (everolimus) plus MMF The primary objective is to demonstrate that an immunosuppressive regimen based on everolimus plus MMF is superior compared to everolimus plus reduced TAC in preserving kidney function as measured by ...

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Comparison of fasting plasma glucose in patients treated with vildagliptin or sitagliptin To assess the difference in FPG between vildagliptin and sitagliptin after two weeks in patients with type 2 diabetes mellitus pre-treated with metformin.

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PRESERVATION OF RENAL FUNCTION IN LIVER TRANSPLANT RECIPIENTS WITH CERTICAN THERAPY: PROTECT Study A twelve-month, multicenter, randomized, open-label study of safety, tolerability and efficacy of Certican-based regimen versus calcineurin inhibitor-based regimen in de novo liver transplant recipients The primary objective is to show superiority of Certican®-based regimen with discontinuation of initial CNI therapy in renal function as compared to continuation of CNI based treatment at 11 months po...

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A 24 week, multicenter, open evaluation of the clinical effectiveness of the once-daily 10 cm2 Exelon® patch formulation in patients with probable Alzheimer’s disease (MMSE10-26) To support the clinical effectiveness of Exelon® target patch size 10 cm² by determining in a real life setting the percentage of patients who stay on the Exelon® target patch size of 10 cm² for at le...

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Patient preferences for Eucreas® versus Victoza® in Type 2 Diabetes mellitus patients The primary objective of this trial is to demonstrate that a higher proportion of subjects with T2DM and inadequate glycemic control have a preference for an oral treatment with the SPC of vildaglipti...

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