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

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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.

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)
We found this trial at
1
site
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
1332
mi
from 91732
Kansas City, KS
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