Effect of Policosanol as Monotherapy and Adjunctive to Statin Therapy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2010-05-31

Brief Summary

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To determine the effects of policosanol on the cholesterol profile.

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Detailed Description

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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.

Conditions

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High Cholesterol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Policosanol 20mg daily

Group Type ACTIVE_COMPARATOR

Policosanol

Intervention Type DRUG

Policosanol 20 mg daily

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo daily

3

Policosanol 20mg daily Plus Statin Therapy Already In Use

Group Type ACTIVE_COMPARATOR

Policosanol Plus Already In Use Statin Therapy

Intervention Type DRUG

Policosanol 20 mg daily Statin Therapy

Interventions

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Policosanol

Policosanol 20 mg daily

Intervention Type DRUG

Placebo

Placebo daily

Intervention Type OTHER

Policosanol Plus Already In Use Statin Therapy

Policosanol 20 mg daily Statin Therapy

Intervention Type DRUG

Other Intervention Names

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Octacosanol, 1-Octacosanol, N-Octacosanol, Octacosyl Alcohol Octacosanol, 1-Octacosanol, N-Octacosanol, Octacosyl Alcohol Statin

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes