Effect of Policosanol as Monotherapy and Adjunctive to Statin Therapy

Overview

To determine the effects of policosanol on the cholesterol profile.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: March 2010

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.

Interventions

  • Drug: Policosanol
    • Policosanol 20 mg daily
  • Other: Placebo
    • Placebo daily
  • Drug: Policosanol Plus Already In Use Statin Therapy
    • Policosanol 20 mg daily Statin Therapy

Arms, Groups and Cohorts

  • Active Comparator: 1
    • Policosanol 20mg daily
  • Placebo Comparator: 2
  • Active Comparator: 3
    • Policosanol 20mg daily Plus Statin Therapy Already In Use

Clinical Trial Outcome Measures

Primary Measures

  • Lipid Profile
    • Time Frame: Change between Week 8 and Baseline

Secondary Measures

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

Participating in This Clinical Trial

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>12×10³/µL)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • James Backes, PharmD
  • Collaborator
    • Marcor Development Corporation
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: James Backes, PharmD, Clinical Associate Professor – University of Kansas Medical Center
  • Overall Official(s)
    • James M. Backes, PharmD, Principal Investigator, University of Kansas Medical Center

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