Status:
COMPLETED
Policosanol for the Treatment of Hypercholesterolemia
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Hyperlipidemia
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Detailed 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. Policosanol h...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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
- Exclusion Criteria
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00255216
Start Date
January 1 2005
End Date
August 1 2005
Last Update
March 30 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Center for Cardiovascular Health
Charlotte, North Carolina, United States, 28207