Effect of Policosanol as Monotherapy and Adjunctive to Statin Therapy

James Backes, PharmD

Status: Completed

Conditions: High Cholesterol

Treatments: Drug: Policosanol; Other: Placebo; Drug: Policosanol Plus Already In Use Statin Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00510809

10494

QB840230

Details and patient eligibility

About

To determine the effects of policosanol on the cholesterol profile.

Full description

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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Description:

Policosanol 20mg daily

Treatment:

Drug: Policosanol

2

Placebo Comparator group

Treatment:

Other: Placebo

3

Active Comparator group

Description:

Policosanol 20mg daily Plus Statin Therapy Already In Use

Treatment:

Drug: Policosanol Plus Already In Use Statin Therapy