Study to assess lung function and patient preference after a 4 week treatment each with QVA149 vs. tiotropium in patients with stable chronic obstructive pulmonary disease (COPD) and moderate to severe airflow limitation who are on a tiotropium therapy To demonstrate superiority of QVA149 (100/50 µg o.d.) as compared to tiotropium (18 µg o.d.) in terms of FEV1 1 h post-inhalation after 4 weeks of treatment in patients with stable COPD and moderate t...

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A one year, open label, multicenter trial of LBH589 alone or in combination with ESA in red blood cell transfusion-dependent LOW and INT-1 MDS patients being either refractory to ESA or with a low probability of response – the GErman PAnobinostat low Risk MDS trial The primary objective of this study is to evaluate the hematological improvement of the erythropoietic system (HI-E) using modified IWG criteria in patients treated for 4 months with LBH589 single ag...

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A study to explore heart function during first dose administration of fingolimod in patients with relapsing-remitting multiple sclerosis To evaluate the incidence of patients with bradycardia (heart rate < 45 beats per min) and bradyarrhythmic ECG events during 6-hour monitoring period as measured by heart rate and second and third-deg...

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Open-label trial of imatinib mesylate (Glivec, formerly known as STI571) in combination with vinorelbine (Navelbine) for patients with advanced breast carcinoma To assess the safety and tolerability of Glivec in combination with Vinorelbine in patients with progressive or metastatic breast cancer after previous anthracycline chemotherapy.

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Study to evaluate renal function of everolimus plus tacrolimus in liver transplant patients To demonstrate that an immunosuppressive regimen based on everolimus (EVR) in co-exposure with tacrolimus (TAC) has superior efficacy compared to tacrolimus alone on estimated glomerular filtration ra...

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6-month, open-label, randomized, multicenter, prospective, controlled study to evaluate the efficacy, safety and tolerability of Everolimus in de novo renal transplant recipients participating in the Eurotransplant senior program The primary objective of this trial is to exploratively examine superiority of a treatment regimen with Certican with respect to the renal function at 6 months after renal transplantation (Tx) assesse...

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A 2 x 5 weeks open label, multicenter, randomized cross-over study to compare the reduction of predialysis systolic blood pressure with valsartan (Diovan) 80 mg compared to irbesartan150 mg in patients with mild to moderate hypertension on long-term hemodialysis The primary efficacy variable is predialytic MSSBP after 4 weeks treatment with valsartan 80 mg and irbesartan 150 mg.

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Clinical study to evaluate the efficacy and safety of an antiallergic therapy, which will be administered against rhinitis and/or rhinoconjunctivitis with or without intermittent asthma as allergic reaction to birch pollen. The study drug Depiquick® Birch used for this immunotherapy is a chemically modified extract of birch pollen To demonstrate superiority of Depiquick® Birch (1,000 DPP/mL) over Depiquick®-matching placebo (0 DPP/mL) with regard to efficacy of intraseasonal SIT as assessed by the combined symptom and medicatio...

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Phase II study on letrozole in patients with advanced or recurrent hormone receptor positive endometrial cancer clinical response rate (CR/PR)

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An open-label, multi-center, single-arm study to evaluate the efficacy of nilotinib in adult patients with metastatic or unresectable gastrointestinal stromal tumors in first line treatment To evaluate the efficacy of Nilotinib in patients with unresectable or metastatic gastrointestinal stromal tumors. Efficacy is defined as the proportion of patients showing stable disease (SD), partia...

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