Title
Effect of Policosanol as Monotherapy and Adjunctive to Statin Therapy
Safety and Efficacy of Policosanol Monotherapy and When Added to Chronic Statin Therapy: A Pilot Study
Phase
N/ALead Sponsor
University of KansasStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
High CholesterolIntervention/Treatment
policosanol ...Study Participants
54To determine the effects of policosanol on the cholesterol profile.
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.
Policosanol 20 mg daily
Placebo daily
Policosanol 20 mg daily Statin Therapy
Policosanol 20mg daily Plus Statin Therapy Already In Use
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)
| Event Type | Organ System | Event Term | Statin and Policosanol | Statin and Placebo | Policosanol |
|---|
All events reported that were deemed to be related, or unrelated, to the study drug.
