NCT00510809

Brief Summary

To determine the effects of policosanol on the cholesterol profile.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

July 20, 2012

Completed
Last Updated

October 8, 2015

Status Verified

September 1, 2015

Enrollment Period

2.7 years

First QC Date

August 1, 2007

Results QC Date

May 11, 2012

Last Update Submit

September 22, 2015

Conditions

High Cholesterol

Outcome Measures

Primary Outcomes (1)

  • Lipid Profile

    Change between Week 8 and Baseline

Secondary Outcomes (1)

  • Adverse Events Reported

    Week 8

Study Arms (3)

1

ACTIVE COMPARATOR

Policosanol 20mg daily

Drug: Policosanol

2

PLACEBO COMPARATOR
Other: Placebo

3

ACTIVE COMPARATOR

Policosanol 20mg daily Plus Statin Therapy Already In Use

Drug: Policosanol Plus Already In Use Statin Therapy

Interventions

PolicosanolDRUG

Policosanol 20 mg daily

Also known as: Octacosanol, 1-Octacosanol, N-Octacosanol, Octacosyl Alcohol
1
PlaceboOTHER

Placebo daily

2
Policosanol Plus Already In Use Statin TherapyDRUG

Policosanol 20 mg daily Statin Therapy

Also known as: Octacosanol, 1-Octacosanol, N-Octacosanol, Octacosyl Alcohol, Statin
3

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

policosanol1-octacosanolHydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Anticholesteremic AgentsHypolipidemic AgentsAntimetabolitesMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesEnzyme InhibitorsLipid Regulating AgentsTherapeutic Uses

Results Point of Contact

Title
James Backes, PharmD
Organization
University of Kansas Medical Center
JBACKES@kumc.edu
(913) 588-5324

Study Officials

  • James M. Backes, PharmD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

August 1, 2007

First Posted

August 2, 2007

Study Start

July 1, 2007

Primary Completion

March 1, 2010

Study Completion

May 1, 2010

Last Updated

October 8, 2015

Results First Posted

July 20, 2012

Record last verified: 2015-09

Locations

US(1)