Effect of Policosanol as Monotherapy and Adjunctive to St... | NCT00510809

Studies
Effect of Policosanol as Monotherapy and Adjunctive to Statin Therapy

NCT00510809

Sponsor

James Backes, PharmD

Status

Completed

Last Update Posted

Oct 8, 2015Estimated

Enrollment

54Actual

Phase

Not Applicable

Conditions

High Cholesterol

Interventions

Policosanol
Placebo
Policosanol Plus Already In Use Statin Therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

Participant Flow Module

Pre-assignment Details

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
10494

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Mar 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Aug 1, 2007

First Submission Date that Met QC Criteria

Aug 1, 2007

First Posted Date

Aug 2, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

May 11, 2012

Results First Submitted that Met QC Criteria

Jun 18, 2012

Results First Posted Date

Jul 20, 2012Estimated

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2015

Last Update Posted Date

Oct 8, 2015Estimated

Name	Class
Marcor Development Corporation	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Policosanol	Drug	Policosanol 20 mg daily	1	Octacosanol, 1-Octacosanol, N-Octacosanol, Octacosyl Alcohol

Measure	Description	Time Frame
Lipid Profile		Change between Week 8 and Baseline

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

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
James M. Backes, PharmD	University of Kansas Medical Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Kansas Medical Center		Kansas City	Kansas	66160	United States

ID	Title	Description
FG000	Statin and Policosanol	20mg daily, double-blind
FG001	Statin and Placebo	20mg daily, double-blind
FG002	Policosanol	20 mg daily, open label

Baseline Characteristics Module

Baseline Analysis Population Description

Not provided

Type of Units Analyzed

Not provided

Arm/Group Information

ID	Title	Description
BG000	Statin and Policosanol	20mg daily, double-blind
BG001	Statin and Placebo	20mg daily, double-blind

Denominators

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Lipid Profile

Posted

Mean

Standard Error

mg/dl

Change between Week 8 and Baseline

ID	Title	Description
OG000	Statin and Policosanol	20mg daily, double-blind
OG001	Statin and Placebo	20mg daily, double-blind
OG002	Policosanol	20 mg daily, open label

Adverse Events Module

Frequency Threshold

Time Frame

Adverse events were collected over the course of the study using subject reports and questionnaires.

Description

Other events include all reported events, whether or not they were deemed to be related to the study drug.

All-Cause Mortality Comment

Not provided

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Statin and Policosanol	20mg daily, double-blind

Serious Adverse Events

Not provided

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Head cold	General disorders				EG000

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

ID	Term
D006937	Hypercholesterolemia

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases

Intervention Browse Module

MeSH Terms

ID	Term
C080710	policosanol
C044309	1-octacosanol
D019161	Hydroxymethylglutaryl-CoA Reductase Inhibitors

Ancestor Terms

ID	Term
D000924	Anticholesteremic Agents
D000960	Hypolipidemic Agents
D000963	Antimetabolites
D045504	Molecular Mechanisms of Pharmacological Action

Browse Leaves

Not provided

Browse Branches

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