12 results
Primary Objective * To evaluate the effect of a 6-week treatment with elafibranor versus placebo on hepatic lipid composition in subjects with a fatty liver.Secondary objectives * To evaluate the between treatment difference (elafibranor 120 mg/d vs…
PrimaryTo determine whether the palatability of a newly developed formulation of valacyclovir is non-inferior to administration of crushed and suspended tablets in children, is the primary objective of the second phase of the trial.The primary…
The first objective is to evaluate the superiority of CHF 5259 pMDI (glycopyrrolate bromide) (50 µg total daily dose) versus placebo in terms of FEV1 AUC0-12h normalised by time on Day 42.Key Secondary objectiveTo evaluate the superiority of CHF…
To compare progression-free survival (PFS) between the two treatment arms based on assessments by an independent review facility (IRF).
The purpose of the study is to investigate whether the cyclodextrin added to the cholecalciferol formulation has an effect on the vitamin D3 availability in the body. Thus, it will be investigated if concentrations of vitamin D3 that are found in…
The objective of this study is to compare the bioavailability of 100 and 200 mg pills that are produced in different ways: coated or non-coated. Bioavailability means the amount of medication which is available for use in the body. In this study the…
Primary objective• To assess the effect of cytochrome P450 3A4 enzyme (CYP3A4) induction by rifampicin on the pharmacokinetics (PK) of eribulin following intravenous (IV) administrationSecondary objectives• To assess the safety of eribulin when co-…
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The primary objectives of this study are to assess if SAR408701 has a better progression free survival and general overall survival compared to docetaxel, and main secondary endpoints are objective response rate, time to deterioration on health…
The main objective is to evaluate the efficacy and safety of phenytoin cream in patients with neuropathic pain due to CIAP. The second objective is to determine the predictive value of a DOBRET to identify sustained responders.
This imaging methodology will allow an assessment of the extent of airway changes using a triple combination of Budesonide/Glycopyrronium/Formoterol Fumarate (BGF) and the dual combination Glycopyrronium/Formoterol Fumarate (GFF).