8 results
The purpose of this trial is: • to study the effect of a single dose of GAL-054 (the test medication) in healthy volunteers on the functioning of the body, especially on respiration, and compare this with the effect of a single dose of doxapram.• to…
The purpose of this study is testing a respiratory stimulant, doxapram. Painkillers such as morphine and alfentanil mute breathing. This is often undesirable, especially in patients. To counteract this attenuation is often used drugs also take away…
The purpose of this study is to investigate the effectiveness and safety of riociguat (BAY 63-2521) in patients with diffuse cutaneous systemic sclerosis.
The aim of this trial is to test in a first clinical study the above mentioned hypothesis that BAY63-2521 can at least partially correct deltaF508-CFTR function. Therefore, we plan to include patients with Cystic Fibrosis, who are homozygous for the…
To assess the safety and the efficacy on the activity part of the Steatosis Activity Fibrosis (SAF) histological score (inflammation and ballooning) of a 24-week treatment with two doses of lanifibranor (800, 1200 mg/24h) in NASH adult patients.
The primary objective is to assess the proportion of patients in each treatment arm with a satisfactory clinical response as defined by a composite primary endpoint at Week 24.The secondary objective is to demonstrate safety and clinical effect at…
The main objective of our trial is to investigate if doxapram is safe and effective in reducing the composite outcome of death and neurodevelopmental impairment/severe disability at 2 years corrected age as compared to placebo.
Primary objectivesThis Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis and consists of 2 sequential periods - an initial double-blind placebo-controlled period of minimum 72 weeks followed by a double-blind…