Effect of Policosanol as Monotherapy and Adjunctive to Statin Therapy

Not Applicable

Completed

• Conditions: High Cholesterol
• Interventions: Drug: Policosanol; Other: Placebo; Drug: Policosanol Plus Already In Use Statin Therapy

• Registration Number: NCT00510809
• Lead Sponsor: James Backes, PharmD

Brief Summary

To determine the effects of policosanol on the cholesterol profile.

Detailed 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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-08-01
• Study First Submitted QC: 2007-08-01
• Study First Posted: 2007-08-02
• Primary Completion: 2010-03
• Study Completion: 2010-05
• Results First Submitted: 2012-05-11
• Results First Submitted QC: 2012-06-18
• Results First Posted: 2012-07-20
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-22
• Last Update Posted: 2015-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Policosanol	Policosanol 20mg daily
2	Placebo	-
3	Policosanol Plus Already In Use Statin Therapy	Policosanol 20mg daily Plus Statin Therapy Already In Use

Primary Outcome Measures

Name	Time	Method
Lipid Profile	Change between Week 8 and Baseline

Secondary Outcome Measures

Name	Time	Method
Adverse Events Reported	Week 8	All events reported that were deemed to be related, or unrelated, to the study drug.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States