High Cholesterol
Conditions
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.
Interventions
DRUGPolicosanol
Policosanol 20 mg daily
OTHERPlacebo
Placebo daily
DRUGPolicosanol Plus Already In Use Statin Therapy
Policosanol 20 mg daily Statin Therapy
Sponsors
Marcor Development Corporation
James Backes, PharmD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lipid Profile | Change between Week 8 and Baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events Reported | Week 8 | All events reported that were deemed to be related, or unrelated, to the study drug. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Statin and Policosanol 20mg daily, double-blind | 18 |
| Statin and Placebo 20mg daily, double-blind | 18 |
| Policosanol 20 mg daily, open label | 18 |
| Total | 54 |
Baseline characteristics
| Characteristic | Statin and Policosanol | Total | Policosanol | Statin and Placebo |
|---|---|---|---|---|
| Age, Continuous | 54 years STANDARD_DEVIATION 12 | 51 years STANDARD_DEVIATION 13 | 46 years STANDARD_DEVIATION 13 | 54 years STANDARD_DEVIATION 14 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 4 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 49 Participants | 16 Participants | 15 Participants |
| Region of Enrollment United States | 18 participants | 54 participants | 18 participants | 18 participants |
| Sex: Female, Male Female | 12 Participants | 31 Participants | 9 Participants | 10 Participants |
| Sex: Female, Male Male | 6 Participants | 23 Participants | 9 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 18 | 10 / 18 | 5 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 | 0 / 18 |
Outcome results
Primary
Lipid Profile
Time frame: Change between Week 8 and Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Statin and Policosanol | Lipid Profile | LDL-C | -4 mg/dl | Standard Error 1.95 |
| Statin and Policosanol | Lipid Profile | Lp (a) | 0 mg/dl | Standard Error 0.11 |
| Statin and Policosanol | Lipid Profile | HDL-C | 0 mg/dl | Standard Error 0.17 |
| Statin and Policosanol | Lipid Profile | Triglycerides | 4 mg/dl | Standard Error 1.52 |
| Statin and Policosanol | Lipid Profile | Total Cholesterol | -5 mg/dl | Standard Error 1.67 |
| Statin and Policosanol | Lipid Profile | VLDL | -1 mg/dl | Standard Error 0.13 |
| Statin and Policosanol | Lipid Profile | non-HDL | -4 mg/dl | Standard Error 1.87 |
| Statin and Placebo | Lipid Profile | non-HDL | -4 mg/dl | Standard Error 1.45 |
| Statin and Placebo | Lipid Profile | Total Cholesterol | -5 mg/dl | Standard Error 0.92 |
| Statin and Placebo | Lipid Profile | LDL-C | 4 mg/dl | Standard Error 1.49 |
| Statin and Placebo | Lipid Profile | HDL-C | -1 mg/dl | Standard Error 0.23 |
| Statin and Placebo | Lipid Profile | Triglycerides | -2 mg/dl | Standard Error 3.91 |
| Statin and Placebo | Lipid Profile | Lp (a) | 0 mg/dl | Standard Error 4.69 |
| Statin and Placebo | Lipid Profile | VLDL | 1 mg/dl | Standard Error 0.17 |
| Policosanol | Lipid Profile | Total Cholesterol | 2 mg/dl | Standard Error 1.96 |
| Policosanol | Lipid Profile | HDL-C | -1 mg/dl | Standard Error 0.39 |
| Policosanol | Lipid Profile | VLDL | 3 mg/dl | Standard Error 0.1 |
| Policosanol | Lipid Profile | LDL-C | 0 mg/dl | Standard Error 0.34 |
| Policosanol | Lipid Profile | Lp (a) | 1 mg/dl | Standard Error 0.08 |
| Policosanol | Lipid Profile | non-HDL | 3 mg/dl | Standard Error 0.53 |
| Policosanol | Lipid Profile | Triglycerides | 35 mg/dl | Standard Error 4 |
Secondary
Adverse Events Reported
All events reported that were deemed to be related, or unrelated, to the study drug.
Time frame: Week 8
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Statin and Policosanol | Adverse Events Reported | 6 number of events reported |
| Statin and Placebo | Adverse Events Reported | 10 number of events reported |
| Policosanol | Adverse Events Reported | 5 number of events reported |