Effect of Policosanol as Monotherapy and Adjunctive to Statin Therapy

September 22, 2015 updated by: James Backes, PharmD

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

To determine the effects of policosanol on the cholesterol profile.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Other: Placebo
Placebo daily
Active Comparator: 1
Policosanol 20mg daily
Drug: Policosanol
Policosanol 20 mg daily
Other Names:
  • Octacosanol, 1-Octacosanol, N-Octacosanol, Octacosyl Alcohol
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:
  • Statin
  • Octacosanol, 1-Octacosanol, N-Octacosanol, Octacosyl Alcohol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lipid Profile
Time Frame: Change between Week 8 and Baseline
Change between Week 8 and Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events Reported
Time Frame: Week 8
All events reported that were deemed to be related, or unrelated, to the study drug.
Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

James Backes, PharmD

Collaborators

Marcor Development Corporation

Investigators

  • Principal Investigator: James M. Backes, PharmD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

August 1, 2007

First Submitted That Met QC Criteria

August 1, 2007

First Posted (Estimate)

August 2, 2007

Study Record Updates

Last Update Posted (Estimate)

October 8, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QB840230
  • 10494

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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