Effect of Policosanol as Monotherapy and Adjunctive to Statin Therapy
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | July 2007 |
| End Date: | May 2010 |
Safety and Efficacy of Policosanol Monotherapy and When Added to Chronic Statin Therapy: A Pilot Study
To determine the effects of policosanol on the cholesterol profile.
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.
[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.
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)
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