Effect of Policosanol as Monotherapy and Adjunctive to Statin Therapy

Study Overview
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Brief Summary
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To determine the effects of policosanol on the cholesterol profile.

Detailed Description
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The primary objectives of this study are to determine the changes in the lipid profile [LDL-C, HDL-C, triglycerides, total cholesterol] and the emerging risk factor, Lp(a), when policosanol is added to statin therapy. Additionally, one more primary objective is to evaluate the safety of the combination regimen.

Official Title
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Safety and Efficacy of Policosanol Monotherapy and When Added to Chronic Statin Therapy: A Pilot Study

Conditions
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High Cholesterol

Intervention / Treatment
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* Drug: Policosanol
* Other: Placebo
* Drug: Policosanol Plus Already In Use Statin Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: LDL > 100 Male or Non-Pregnant Female. Women must be surgically sterile or postmenopausal and not using hormone replacement therapy (HRT) or using a stable, consistent HRT dose with intentions to continue therapy throughout the course of the study Mentally competent to understand study rationale and protocol Speak and read English Currently receiving low to moderate dose statin therapy with plans to continue to the same dose for at least 8 weeks. Low to moderate dose statins include the following daily doses: atorvastatin ≤20 mg, fluvastatin ≤40 mg, lovastatin ≤40 mg, pravastatin ≤40 mg, rosuvastatin ≤10 mg, simvastatin ≤ 40 mg Exclusion Criteria: LDL < 100 Sensitivity to policosanol Currently taking a high-dose statin or other lipid-lowering agents (i.e. high-dose niacin formulations [>500mg/day], bile-acid sequestrants, ezetimibe, fibrates and high-dose Omega-3 fish oils [>900mg of combined EPA/DHA daily]) Currently taking medications which have the potential to interact with policosanol (i.e. warfarin, high-dose aspirin) Active liver disease or ALT level 2.5 times the upper limit of normal Chronic disease involving hepatic, renal or coronary artery disease Currently experiencing flu-like symptoms Currently experiencing any form of acute physical injury Acute psychiatric disorders Immuno-compromised state Currently taking systemic steroidal drugs Currently pregnant or lactating Females of childbearing potential Dependence on alcohol or illicit drugs Participation in any other clinical trial within the last 30 days Displays s/s of acute systemic infection (oral temperature >100°F, WBC>12x10³/µL)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Policosanol 20mg daily | Drug: Policosanol<br>* Policosanol 20 mg daily<br>* Other names: Octacosanol, 1-Octacosanol, N-Octacosanol, Octacosyl Alcohol;|
| Placebo Comparator: 2<br> | Other: Placebo<br>* Placebo daily<br>|
| Active Comparator: 3<br>Policosanol 20mg daily Plus Statin Therapy Already In Use | Drug: Policosanol Plus Already In Use Statin Therapy<br>* Policosanol 20 mg daily Statin Therapy<br>* Other names: Statin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid Profile |  | Change between Week 8 and Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events Reported | All events reported that were deemed to be related, or unrelated, to the study drug. | Week 8 |