3 results
Approved WMOPending
To evaluate the efficacy and safety of extended release (ER) Niacin/Laropiprant when added to ongoing lipid-modifying therapy in patients with primary hypercholesterolemia or mixed dyslipidemia.
Approved WMOCompleted
The primary objective is to examine the pharmacokinetics of Nanogam 100 mg/ml and compare these with Nanogam 50 mg/ml. The secondary objective is safety and tolerability of Nanogam 100 mg/ml. Aim is to show bioequivalency between Nanogam 50 mg/ml…
Approved WMOCompleted
To evaluate the safety and performance of the Lotus Valve system for transcathether aortic valve replacment (TAVR) in symptomatic subjects with severe calcific aortic stenosis who are considered high risk for surgical valve replacement.