drugset / Trial / NCT00255216

Policosanol for the Treatment of Hypercholesterolemia

NCT00255216

RandomizedParallel-groupDouble-blindTreatment

Summary

Policosanol, a compound derived from sugar cane wax and available in health food stores across the United States, is a popular non-prescription product for treating hypercholesterolemia. Virtually all of the published medical literature on policosanol has been authored by research groups in Cuba. This study will assess the short-term safety and efficacy of policosanol in healthy adults who have a baseline LDL-C of 130-200. The recruitment population will be derived from primary care clinics consisting primarily of Caucasian and African-American patients. The primary outcome measurements will be the percentage change in LDL-C. Secondary outcomes will include changes in total cholesterol, HDL-C, triglycerides, C-reactive protein, and lipoprotein sub-particles. This will be the first known randomized clinical trial of policosanol in North America. The data derived from this pilot study regarding the lipid lowering effects of policosanol will be used to support applications for further funding through institutions outside the Carolinas Healthcare System including the National Institute of Health (NIH). Specific Aim: To independently corroborate the lipid lowering effects of policosanol in a small pilot study.

Timeline

Start
2005-01
Primary completion
Completion
2005-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Policosanol Small molecule 40 mg Oral

Indications