drugset / Trial / NCT00150722

High-Density Lipoprotein (HDL) Modulation and Endothelial Function

NCT00150722

RandomizedCrossoverQuadruple-blindTreatment

Summary

It is well known that lowering low-density lipoprotein (LDL) (bad cholesterol) is beneficial for decreasing heart attacks and death. More recently, focus has been on trying to raise HDL (good) cholesterol. The purpose of the present study is to determine if the addition of a sustained release preparation of niacin (Niaspan - a medicine to raise HDL cholesterol) to LDL lowering with a statin type medication results in improved vascular health. The study of the well being of one's vessel wall (endothelial function) will serve as a marker of treatment effect in the study. Hypotheses: Extended-release (ER) niacin will improve endothelial function measured as brachial flow-mediated dilation (FMD - 10 end-point) and as pulse volume amplitude by pulse arterial tonometry (PAT) (20 end-point) in subjects with established atherosclerosis whose LDL cholesterol is optimally treated with statin therapy.

Timeline

Start
2005-09
Primary completion
2008-08
Completion
2008-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Niacin Small molecule 1500 mg
Background Atorvastatin Small molecule 80 mg

Indications