Effect of Policosanol as Monotherapy and Adjunctive to Statin Therapy - Full Text View

Sponsors and Collaborators:	University of Kansas Marcor
Information provided by:	University of Kansas
ClinicalTrials.gov Identifier:	NCT00510809

Purpose

To determine the effects of policosanol on the cholesterol profile.

Condition	Intervention
High Cholesterol	Drug: Policosanol Other: Placebo Drug: Policosanol Plus Already In Use Statin Therapy

MedlinePlus related topics: Cholesterol Statins

Drug Information available for: Ethanol Octacosanol Policosanol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Safety and Efficacy of Policosanol Monotherapy and When Added to Chronic Statin Therapy: A Pilot Study

Further study details as provided by University of Kansas:

Primary Outcome Measures:

Lipid Profile [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Lipid Profile and any Adverse Events Reported [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	54
Study Start Date:	July 2007
Estimated Study Completion Date:	July 2008
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Policosanol 20mg daily	Drug: Policosanol Policosanol 20 mg daily
2: Placebo Comparator	Other: Placebo Placebo daily
3: Active Comparator Policosanol 20mg daily Plus Statin Therapy Already In Use	Drug: Policosanol Plus Already In Use Statin Therapy Policosanol 20 mg daily Statin Therapy

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00510809

Contacts

Contact: Julie-Ann Dutton

913-588-4064

jdutton@kumc.edu

Locations

United States, Kansas
University of Kansas Medical Center	Recruiting
Kansas City, Kansas, United States, 66160
Contact: Julie-Ann Dutton 913-588-4064 jdutton@kumc.edu
Principal Investigator: James M. Backes, PharmD

Sponsors and Collaborators

University of Kansas

Marcor

Investigators

Principal Investigator:

James M. Backes, PharmD

University of Kansas

More Information

Responsible Party:	University of Kansas Medical Center ( James Backes PharmD )
Study ID Numbers:	QB840230, 10494
Study First Received:	August 1, 2007
Last Updated:	June 11, 2008
ClinicalTrials.gov Identifier:	NCT00510809
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Policosanol
Ethanol

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Therapeutic Uses

Hematologic Agents
Platelet Aggregation Inhibitors
Anticholesteremic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009