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OpenTrials
Completed

NCT Number: NCT00510809

Effect of Policosanol as Monotherapy and Adjunctive to Statin Therapy

To determine the effects of policosanol on the cholesterol profile.

Completed

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Key information

Conditions

High Cholesterol Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Policosanol

Drug

Policosanol 20 mg daily

Other names: Octacosanol, 1-Octacosanol, N-Octacosanol, Octacosyl Alcohol

Placebo

Other

Placebo daily

Policosanol Plus Already In Use Statin Therapy

Drug

Policosanol 20 mg daily Statin Therapy

Other names: Octacosanol, 1-Octacosanol, N-Octacosanol, Octacosyl Alcohol, Statin

Primary outcomes

  1. Lipid Profile

    Time frame: Change between Week 8 and Baseline

Secondary outcomes

  1. Adverse Events Reported

    Time frame: Week 8

    All events reported that were deemed to be related, or unrelated, to the study drug.

Sponsors and collaborators

Lead sponsor

James Backes, PharmD

Other

Collaborators

  • Marcor Development Corporation

Registry information

Official study title

Safety and Efficacy of Policosanol Monotherapy and When Added to Chronic Statin Therapy: A Pilot Study

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Aug 2, 2007
Registry last updated
Oct 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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