The study had three arms, a low dose arm with 24 subjects, a dose-escalation arm with 24 subjects and a third high dose arm with 24 subjects. This study also examined early markers for reverse cholesterol transport such as ApoA-I, pre-beta HDL and alpha HDL sub-particles. Approximately half of the subjects had low baseline HDL – cholesterol.. The phase 1b/2a trial was a double blind safety and tolerability study, the pharmacokinetics and pharmacodynamics also examined early effects of RVX-208. A total of 72 patients were enrolled in the study.
Expanded Phase 2 planning ahead to include Phase 2 IVUS trials, a Phase 2 dosing trial and a Phase 2 combination statin trial. The IVUS Steering Committee is led by Dr. Steven Nissen, chairman the Cleveland Clinic Department of Cardiovascular Medicine, chaired and the principal investigator is Dr. Stephen Nicholls, Medical Director of Intravascular Ultrasound at the Cleveland Clinic. In we have observed in our second clinical trial emerging emerging pattern of predictability far 162 volunteers have RVX – 208, which itself has consistently shown that a well-tolerated and safe therapeutic received, ‘said Dr.In 2006, to FDA approval of use Helixate FS at room temperature for stored for three months. The guidelines for the storage to hemophilia treating offer the user more flexibility and simplifies storage choices.