Clinical trial NCT00510809: Effect of Policosanol as Monotherapy and Adjunctive to Statin Therapy
Official title: Safety and Efficacy of Policosanol Monotherapy and When Added to Chronic Statin Therapy: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Cholesterol
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Marcor Development Corporation
First posted: 2007-08-02
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Lipid Profile
timeFrame: Change between Week 8 and Baseline
Secondary outcomes:
measure: Adverse Events Reported
timeFrame: Week 8
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: James M. Backes, PharmD
role: PRINCIPAL_INVESTIGATOR
References: