Effect of Policosanol as Monotherapy and Adjunctive to Statin Therapy

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine the effects of policosanol on the cholesterol profile.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: James Backes, PharmD
• Collaborator: Marcor Development Corporation
• Treatments: Ethanol; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Policosanol

Criteria

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)