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Effect of Policosanol as Monotherapy and Adjunctive to Statin Therapy

Primary Purpose

High Cholesterol

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Policosanol
Placebo
Policosanol Plus Already In Use Statin Therapy
Sponsored by
James Backes, PharmD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for High Cholesterol

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

Policosanol 20mg daily

Policosanol 20mg daily Plus Statin Therapy Already In Use

Outcomes

Primary Outcome Measures

Lipid Profile

Secondary Outcome Measures

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

Full Information

First Posted
August 1, 2007
Last Updated
September 22, 2015
Sponsor
James Backes, PharmD
Collaborators
Marcor Development Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00510809
Brief Title
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

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
James Backes, PharmD
Collaborators
Marcor Development Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Cholesterol

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Policosanol 20mg daily
Arm Title
2
Arm Type
Placebo Comparator
Arm Title
3
Arm Type
Active Comparator
Arm Description
Policosanol 20mg daily Plus Statin Therapy Already In Use
Intervention Type
Drug
Intervention Name(s)
Policosanol
Other Intervention Name(s)
Octacosanol, 1-Octacosanol, N-Octacosanol, Octacosyl Alcohol
Intervention Description
Policosanol 20 mg daily
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo daily
Intervention Type
Drug
Intervention Name(s)
Policosanol Plus Already In Use Statin Therapy
Other Intervention Name(s)
Octacosanol, 1-Octacosanol, N-Octacosanol, Octacosyl Alcohol, Statin
Intervention Description
Policosanol 20 mg daily Statin Therapy
Primary Outcome Measure Information:
Title
Lipid Profile
Time Frame
Change between Week 8 and Baseline
Secondary Outcome Measure Information:
Title
Adverse Events Reported
Description
All events reported that were deemed to be related, or unrelated, to the study drug.
Time Frame
Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James M. Backes, PharmD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

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Effect of Policosanol as Monotherapy and Adjunctive to Statin Therapy

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