Effect of Policosanol as Monotherapy and Adjunctive to Statin Therapy
This study has been completed.
Sponsor:
James Backes, PharmD
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
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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:
|
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
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 Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Policosanol Hydroxymethylglutaryl-CoA Reductase Inhibitors Platelet Aggregation Inhibitors Hematologic Agents |
Therapeutic Uses Pharmacologic Actions Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013