3 results
Approved WMOCompleted
Objectives: For patients with connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) enrolled in this study, the objectives are as follows:Primary: -To assess the efficacy of bardoxolone methyl relative to placebo.Secondary…
Approved WMOCompleted
Primary ObjectiveThe primary objective of the study is:• To compare the efficacy of 6.0, 7.5, and 9.0 g of FT218 to placebo in treating EDS in both NT1 and NT2 subjects as measured by mean sleep latency on the Maintenance of Wakefulness Test (MWT)…
Approved WMOCompleted
To provide continuing open-label treatment with bardoxolone methyl as part of this extended access program while collecting ongoing safety and tolerability data of bardoxolone methyl.