18 results
The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to placebo given for 24 weeks as add-on therapy to stable treatment in elderly patients with diabetes mellitus…
The primary objective of the study is to demonstrate the superiority of the combination BAY 60 4552 / vardenafil over vardenafil alone in the treatment of erectile dysfunction not sufficiently responsive to standard therapy with PDE5 inhibitors.The…
A better understanding on the individual response to different albuminuria lowering drugs and a better understanding why these drugs, of which some are developed for another indication, may help to tailor optimal therapy. Therefore in this study…
Primary objective:To observe an increase in Overall Response Rate (ORR) from 20% in the pembrolizumab alone arm to 50% in the pembrolizumab after SBRT arm at 12 weeks. Secondary Objective: - Disease Control Rate, defined as the percentage of…
CAROLINA studyThe aim of the present study is to investigate the long*term impact on CV morbidity and mortality and relevant efficacy parameters (HbA1c, fasting plasma glucose, treatment sustainability) of treatment with linagliptin in a relevant…
Primary objective of the study is• To investigate efficacy and safety of different oraldoses of BAY94-8862 given once daily over 90 daysThe secondary objectives are:•To assess the effects of these doses on a compositeendpoint of death from any cause…
Primary• To assess the safety profile and determine the pediatric maximum tolerated dose and/or recommended phase 2 dose of brentuximab vedotin• To assess the pharmacokinetics of brentuximab vedotin• To determine the overall response rate (complete…
zie study protocol
Primary objective: What are the long-term effects (i.e. after 8-week drug exposure) of the DPP-4i linagliptin versus the SU derivative glimepiride on fasting and postprandial renal hemodynamics (glomerular filtration rate (GFR)/ effective renal…
The primary objective is to demonstrate non-inferiority (by means of comparing the upper limit of a two-sided 95% confidence interval with the non-inferiority margin of 1.3) of treatment with linagliptin in comparison to placebo (as add-on therapy…
A better understanding on the individual response to different albuminuria lowering drugs and a better understanding why these drugs, of which some are developed for another indication, may help to tailor optimal therapy. Therefore in this study…
That patients who have had clinical response or clinical remission after use with Risankizumab can continue using Risankizumab. Also long term safety of Risankizumab will be assessed in patients who were diagnosed with moderate to severe Crohn'…
Lead in phase 1Primary objective:• To identify the feasibility and RDL (recommended dose level) of brentuximab vedotin in combination with R-DHAPSecondary objective:• To assess the toxicity of brentuximab vedotin in combination with R-DHAP• To…
There are two treatment groups in this study: one with participants at low risk of deterioration and one with participants at standard risk of deterioration. The primary objective for each group is described below.-Low Risk group: To describe the…
primary objective of the trial is to demonstrate non-inferior efficacy of 4-6 cycles of BrECADD compared to 4-6 cycles of escalated BEACOPP, each followed by radiotherapy on PET-positive residual lesions, in terms of progression free survival (…
Primary: To characterize the safety and tolerability of LXH254 single agent and to identify recommended doses for future studies in adult patients with advanced solid tumors harboring MAPK pathway alterations.To characterize the safety and…
• Determine a feasible 89Zr-brentuximab-PET imaging schedule, to allow assessment of the biodistribution of 89Zr-brentuximab in tumor and non-target lesions or -organs.• Establish safety profile, pharmacokinetics (PK), and pharmacodynamics (PD) of…
DINAMOTM (main study)The objective of this study is to assess the efficacy and safety of anempagliflozin dosing regimen and one dose of linagliptin versus placebo after 26 weeks of treatment in children and adolescents with type 2 diabetes mellitus…