30 results
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 objectives:1) To evaluate the safety of four different CHMI-trans protocols in healthy malaria-naïve volunteers challenged with Plasmodium falciparum by sporozoite challenge. 2) To determine the best CHMI-trans protocol for induction of…
The objective of this study is to assess the efficacy, safety, tolerability and pharmacokinetics (PK) of once daily oral doses of empagliflozin 2,5mg, 10mg and 25mg in patients with Type 1 diabetes mellitus (T1DM) as adjunctive to insulin therapy.…
The objective of this study is to assess the efficacy, safety, tolerability and pharmacokinetics (PK) of once daily oral doses of empagliflozin 10 in patients with Type 1 diabetes mellitus (T1DM) as adjunctive to insulin therapy. Empagliflozin is…
Primary objectives: To assess the ability of dabrafenib + trametinib treatment to downsize melanoma tumor masses to enable R0-resection. Secondary objectives: Recurrence free survival; time-to-next treatment, overall survival.
Primary:The primary objective of this trial is to evaluate whether empagliflozin 10mg/day will relieve dyspnea, improves diuretic response, decreases length of initial hospital stay and NT-proBNP compared to placebo during hospital admission for…
Primary: overall response rate.Secondary: progression free survival, duration of response, overall survival, safety, tolerability, pharmacokinetics (PK).
To examine the effects of mono- and combination therapy with linagliptin and empagliflozine on renal hemodynamics
Primary: efficacy of dabrafenib and trametinib combination therapy compared to placebo with respect to overall response rate in subjects with rare BRAF V600E mutated solid tumors or hematologic malignancies.Secondary: duration of response,…
The objective of this event-driven trial is to demonstrate superiority of empagliflozin 10 mg versus placebo in patients with symptomatic, chronic HF and preserved ejection fraction (LVEF > 40%) under stable treatment of HF symptoms.
The main objective of this study is to assess whether in-hospital administration of empagliflozin results in improvement in HF-related outcomes in patients hospitalised for acute heart failure (de novo or decompensated chronic HF) and after initial…
Primary:To assess the long-term safety of treatment with dabrafenib, trametinib or the combination.Secondary:To assess the long-term effect of treatment with dabrafenib, trametinib or the combination on general health, growth and development.To…
This study aims to demonstrate the effectiveness of dabrafenib with trametinib in pediatric patients with BRAF V600 mutant relapsed refractory HGG.This study aims to demonstrate the effectiveness of dabrafenib with trametinib compared to…
The objective of this event-driven trial is to demonstrate superiority of empagliflozin 10 mg versus placebo on top of guideline-directed medical therapy in patients with symptomatic, chronic HF and reduced ejection fraction (LVEF * 40%).
Primary objectives: To explore the safety, feasibility, and the immune-activating capacity of different schemes of continuous/intermittent dabrafenib+trametinib during treatment with pembrolizumab as compared to pembrolizumab monotherapySecondary…
Primary: superiority of dabrafenib and trametinib combination therapy over vemurafenib monotherapy with respect to overall survival for subjects with advanced/metastatic BRAF V600E/K mutation-positive cutaneous melanoma.Secondary: progression free…
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 determine whether ITCA 650 is non-inferior either to empagliflozin or to glimepiride in reducing glycosylated hemoglobin A1c (HbA1c) or weight in patients with T2D following 65 weeks of treatment. The non-inferiority margins…
Main study objective is to find out which dose among three different doses of LIK066 is the most efficacious, safe and well tolerated in type 2 diabetes patients with heart failure. We will also learn which medication is better at managing patients…
To demonstrate that a dose reduction of 20-33% of CYP3A4 metabolized tyrosine kinase inhibitors in patients expressing the CYP3A4*22 gene (rs35599367 C>T in intron 6) does not result in a lower exposure (Ctrough) than the wildtype group with…