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Effect of Policosanol as Monotherapy and Adjunctive to Statin Therapy

This study has been completed.
Sponsor:
Collaborator:
Marcor Development Corporation
Information provided by (Responsible Party):
James Backes, PharmD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00510809
First received: August 1, 2007
Last updated: June 18, 2012
Last verified: April 2012
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Policosanol Monotherapy and When Added to Chronic Statin Therapy: A Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Lipid Profile [ Time Frame: Change between Week 8 and Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Events Reported [ Time Frame: Week 8 ] [ Designated as safety issue: Yes ]
    All events reported that were deemed to be related, or unrelated, to the study drug.


Enrollment: 54
Study Start Date: July 2007
Study Completion Date: May 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Policosanol 20mg daily
Drug: Policosanol
Policosanol 20 mg daily
Other Name: Octacosanol, 1-Octacosanol, N-Octacosanol, Octacosyl Alcohol
Placebo Comparator: 2 Other: Placebo
Placebo daily
Other Name: placebo
Active Comparator: 3
Policosanol 20mg daily Plus Statin Therapy Already In Use
Drug: Policosanol Plus Already In Use Statin Therapy
Policosanol 20 mg daily Statin Therapy
Other Names:
  • Octacosanol, 1-Octacosanol, N-Octacosanol, Octacosyl Alcohol
  • Statin

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
James Backes, PharmD
Marcor Development Corporation
Investigators
Principal Investigator: James M. Backes, PharmD University of Kansas
  More Information

No publications provided

Responsible Party: James Backes, PharmD, Clinical Associate Professor, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00510809     History of Changes
Other Study ID Numbers: QB840230, 10494
Study First Received: August 1, 2007
Results First Received: May 11, 2012
Last Updated: June 18, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Policosanol
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hematologic Agents
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Platelet Aggregation Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014