7 results
* To assess the long-term safety and tolerability of ZX008.
The primary objective is to determine the effect of low dose (0.5mg once daily) colchicine on the occurrence of the composite endpoint of acute coronary syndrome, fatal or non-fatal out of hospital cardiac arrest and atherosclerotic stroke in…
The primary objective of Part 1 is the primary objective of the entire study.Part 1The primary objective of Part 1 is:* To evaluate the effect of ZX008 0.8 mg/kg/day versus placebo as adjunctive therapy for the treatment of uncontrolled seizures in…
The primary efficacy objectives of this two-cohort study are:o To demonstrate that ZX008 is superior to placebo as adjunctive therapy in the treatment of symptoms of Dravet syndrome in children and young adults based on change in the frequency of…
The objective of this study is to evaluate the safety and performance of the ROX Coupler in subjects with resistant hypertension.
Objectives for Part 1: Primary (Efficacy): To demonstrate that the efficacy of fenfluramine (ZX008) 0.8 mg/kg/day is superior to placebo as an adjunctive therapy for pediatric and adult subjects with CDD Secondary (Safety): To characterize the…
In patients with acute MI (STEMI or Non-STEMI) who have undergone PCI, the objectives are to determine: 1. If colchicine can reduce the incidence of cardiovascular death, recurrent MI, or stroke. 2. If routine use of spironolactone can reduce the…