Effect of Policosanol as Monotherapy and Adjunctive to Statin Therapy

High Cholesterol Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00510809
• Other study ID #: QB840230
• Secondary ID: 10494
• Status: Completed
• Phase: N/A
• First received: August 1, 2007
• Last updated: September 22, 2015
• Start date: July 2007
• Est. completion date: May 2010

Study information

• Verified date: September 2015
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To determine the effects of policosanol on the cholesterol profile.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• High Cholesterol
• Hypercholesterolemia

Intervention

Drug:
• Policosanol
Policosanol 20 mg daily

Other:
• Placebo
Placebo daily

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

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
James Backes, PharmD	Marcor Development Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lipid Profile		Change between Week 8 and Baseline	No
Secondary	Adverse Events Reported	All events reported that were deemed to be related, or unrelated, to the study drug.	Week 8	Yes