12 results
To study the pharmacokinetics of linezolid in MDR-TB patients, specifically in the relationship to dose, treatment duration and toxicity.
The aim of the substudy is the identification of early (baseline) predictors of heart failure during a relatively high frequency of electrical stiumulation of the right ventricle. How does heart function change over a period of 2 years which…
The primary objective is to quantify the LIN AUC0-12h increase after addition of 250 mg, or 500 mg CLA compared to baseline (0 mg CLA). The secondary objectives are to describe the LIN and CLA pharmacokinetic parameters and to assess short-term…
Primary: Safety and tolerability of fingolimod 0,5 mg in a broader population of MS patients.Explorerend: incidence of macular edema, bradyarrythmia, Patient-Reported Outcomes Indices for Multiple Sclerosis (PRIMuS) and Short Form Health Survey*12 (…
The hypothesis is that a switch from intravenous to oral antimicrobial therapy is non-inferior to standard intravenous therapy in patients with low-risk SAB. Therefore, the primary objective of the trial is to demonstrate, that oral switch therapy (…
The Primary Objectives for the study are:* Demonstrate the non-inferiority (NI) of lefamulin versus comparator with respect to the Early Clinical Response (96 ± 24 hours after the first dose of study drug) in the Intent to Treat (ITT) Analysis Set (…
The purpose of this study is to seek regulatory approval for use of fingolimod in a pediatric population with MS aged 10 to less than 18 years old. This study is conducted in line with the Pediatric Investigational Plan agreed with the EMA (under EU…
Primary: Safety and tolerability of fingolimod 0,5 mg.Secundairy: Efficacy and quality of life.
The purpose of this study in patients with primary progressive multiple sclerosis (PPMS) is to evaluatewhether FTY720 is effective in delaying MS disability progression in the absence of relapsescompared to placebo. Furthermore, safety and…
- To determine the effects of the pacing site on prevention of AF episodes - To examine the relation between the pacing site, reduction of AF episodes, quality of life, heart failure, number of cardioversions, frequency and duration of hospital…
Primary: Safety and tolerability of fingolimod 0,5 mg.Secundairy: Long-term efficacy.Exploratory: Patient-Reported Outcomes Indices for Multiple Sclerosis (PRIMuS) and Short Form Health Survey*12 (SF-12), Treatment Satisfaction Questionnaire for…
The primary objective of this study is to compare in a randomized trial the effects of permanent LVSP with RVP in patients with a pacemaker indication because of AV conduction disorders, with respect to a composite of all-cause mortality,…