5 results
Primary Objectives:To assess the incidence and the time to confirmed IFI in subjects treated pre-emptively with micafungin versus placebo.
Primary Objectives 1. To evaluate the pharmacokinetics of fluconazole and micafungin both administered after randomization in neonates with suspected or culture-proven Candidiasis in order to validate their optimal dosage and identify covariates…
Primary objective:To determine the effect of obesity (BMI > 40kg/m2) on the pharmacokinetics of micafungin and develop a dosing regimen for obese patients. Secondary objective:* To describe the pharmacokinetics of the approved dose of 200mg…
In a pilot study patients scheduled for a regular implantation of a (or undergoing an upgrade to a) CRT-device will also be implanted with a heart monitor in the pulmonary artery. This implantable heart monitor (IHM) will collect data during…
The purpose of this study is to demonstrate the impact on progression of structural damage in the spine as measured by the mSASSS in patients with AS. Data from this study will be used to support the submission of an AS label extension to include a…