NCT00255216

Policosanol for the Treatment of Hypercholesterolemia

Completed NA Last updated 29 March 2023

What this trial tests

NA trial testing Policosanol supplement (oral capsule) vs. placebo in Hyperlipidemia in 40 participants. Completed in 1 August 2005.

Timeline

1 January 2005

1 August 2005

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	40
Start date	1 January 2005
Estimated completion	1 August 2005
Sites	1 location across United States

Drugs / interventions tested

• Policosanol supplement (oral capsule) vs. placebo — full drug profile →

Conditions studied

• Hyperlipidemia — all drugs for Hyperlipidemia →

Sponsor

Wake Forest University Health Sciences

Who can join

18 and older, any sex, with Hyperlipidemia. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Primary Outcome Variables:
• Percent change in LDL-C between baseline and 8 weeks in the policosanol and placebo arms.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.