Policosanol for the Treatment of Hypercholesterolemia

NCT00255216 | Completed

• 1 other identifier: Poli-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (2)

• Primary Outcome Variables:

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

Secondary Outcomes (7)

• Secondary Outcome Variables:

• Percent change between baseline and 8 weeks in both study arms for the following parameters:

• • total cholesterol, HDL-C, and triglycerides

• • hs-CRP

• • LDL Particle concentration

Interventions

Policosanol supplement (oral capsule) vs. placebo DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Males, or females who are not pregnant and have a highly reliable contraception method (i.e. hormonal or surgical contraception)
• Baseline LDL-C between 130 and 200

You may not qualify if:

• History of Coronary Artery Disease - Patients will be excluded if they have been told at any time that they have heart disease based on a history of abnormal EKG, stress test, or coronary catheterization.
• History of Cerebrovascular Disease - Patients with a history of stroke or TIA will be excluded from the study.
• History of Congestive Heart Disease - Patients will be excluded if they have a history of congestive heart failure, regardless of the underlying cause or stage of disease. This will be true even if patients do not have a history of coronary artery disease.
• History of Diabetes - Patients will be asked if they have ever been diagnosed with any type of diabetes in the past. All patients with diabetes including type I, type II, and gestational diabetes will be excluded.
• History of Renal Impairment - Any patient with a history of kidney problems including transient renal impairment or current renal insufficiency will be excluded.
• History of Uncontrolled Hypertension - If patients report a history of poorly controlled blood pressure, defined as systolic blood pressure consistently over 140 or diastolic blood pressure consistently greater than 90, they will be excluded. Blood pressure will be checked at the beginning of the study and patients will be excluded if the initial reading reveals a systolic blood pressure over 160 and/or a diastolic blood pressure over 100.
• History of Untreated or Clinically Evident Thyroid Disease - Patients will be excluded if they report a history of untreated thyroid disease or current symptoms of an untreated thyroid disorder.
• Currently taking medications or supplements with known or potential lipid-altering effects including: phytosterols, statins, cholestin, niacin, fibrates, psyllium fiber, bile acid sequestrants, diabetic medications, and weight control medications such as orlistat
• Currently having residual side effects from a previously discontinued lipid medication
• Pregnancy or breastfeeding
• Triglycerides \> 300 at baseline
• Patients with clinical atherosclerotic disease which would be considered a coronary heart disease risk equivalent per ATP III guidelines - including carotid artery disease, peripheral arterial disease, and abdominal aortic aneurysm.
• Patients with 2 or more cardiac risk factors and over 20% risk of coronary disease according to their 10- year Framingham risk assessment.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Center for Cardiovascular Health

Charlotte, North Carolina, 28207, United States

Location

MeSH Terms

Conditions

Hyperlipidemias

Interventions

Capsules

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Michael F Dulin, MD PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2005
• First Posted: November 18, 2005
• Study Start: January 1, 2005
• Study Completion: August 1, 2005
• Last Updated: March 30, 2023

Record last verified: 2005-10

Locations

US (1)