Effect of Policosanol as Monotherapy and Adjunctive to Statin Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00510809
Recruitment Status : Completed
First Posted : August 2, 2007
Results First Posted : July 20, 2012
Last Update Posted : October 8, 2015
Marcor Development Corporation
Information provided by (Responsible Party):
James Backes, PharmD, University of Kansas Medical Center

Brief Summary:
To determine the effects of policosanol on the cholesterol profile.

Condition or disease Intervention/treatment Phase
High Cholesterol Drug: Policosanol Other: Placebo Drug: Policosanol Plus Already In Use Statin Therapy Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Policosanol Monotherapy and When Added to Chronic Statin Therapy: A Pilot Study
Study Start Date : July 2007
Actual Primary Completion Date : March 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
Policosanol 20mg daily
Drug: Policosanol
Policosanol 20 mg daily
Other Name: Octacosanol, 1-Octacosanol, N-Octacosanol, Octacosyl Alcohol

Placebo Comparator: 2 Other: Placebo
Placebo daily

Active Comparator: 3
Policosanol 20mg daily Plus Statin Therapy Already In Use
Drug: Policosanol Plus Already In Use Statin Therapy
Policosanol 20 mg daily Statin Therapy
Other Names:
  • Octacosanol, 1-Octacosanol, N-Octacosanol, Octacosyl Alcohol
  • Statin

Primary Outcome Measures :
  1. Lipid Profile [ Time Frame: Change between Week 8 and Baseline ]

Secondary Outcome Measures :
  1. Adverse Events Reported [ Time Frame: Week 8 ]
    All events reported that were deemed to be related, or unrelated, to the study drug.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00510809

United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
James Backes, PharmD
Marcor Development Corporation
Principal Investigator: James M. Backes, PharmD University of Kansas Medical Center

Responsible Party: James Backes, PharmD, Clinical Associate Professor, University of Kansas Medical Center Identifier: NCT00510809     History of Changes
Other Study ID Numbers: QB840230
First Posted: August 2, 2007    Key Record Dates
Results First Posted: July 20, 2012
Last Update Posted: October 8, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents
Platelet Aggregation Inhibitors