Trial Outcomes & Findings for Effect of Policosanol as Monotherapy and Adjunctive to Statin Therapy (NCT NCT00510809)
NCT ID: NCT00510809
Last Updated: 2015-10-08
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
54 participants
Primary outcome timeframe
Change between Week 8 and Baseline
Results posted on
2015-10-08
Participant Flow
Participant milestones
| Measure |
Statin and Policosanol
20mg daily, double-blind
|
Statin and Placebo
20mg daily, double-blind
|
Policosanol
20 mg daily, open label
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
18
|
|
Overall Study
COMPLETED
|
18
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Policosanol as Monotherapy and Adjunctive to Statin Therapy
Baseline characteristics by cohort
| Measure |
Statin and Policosanol
n=18 Participants
20mg daily, double-blind
|
Statin and Placebo
n=18 Participants
20mg daily, double-blind
|
Policosanol
n=18 Participants
20 mg daily, open label
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 12 • n=93 Participants
|
54 years
STANDARD_DEVIATION 14 • n=4 Participants
|
46 years
STANDARD_DEVIATION 13 • n=27 Participants
|
51 years
STANDARD_DEVIATION 13 • n=483 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
31 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
23 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
49 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=93 Participants
|
18 participants
n=4 Participants
|
18 participants
n=27 Participants
|
54 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Change between Week 8 and BaselineOutcome measures
| Measure |
Statin and Policosanol
n=18 Participants
20mg daily, double-blind
|
Statin and Placebo
n=18 Participants
20mg daily, double-blind
|
Policosanol
n=18 Participants
20 mg daily, open label
|
|---|---|---|---|
|
Lipid Profile
Total Cholesterol
|
-5 mg/dl
Standard Error 1.67
|
-5 mg/dl
Standard Error .92
|
2 mg/dl
Standard Error 1.96
|
|
Lipid Profile
LDL-C
|
-4 mg/dl
Standard Error 1.95
|
4 mg/dl
Standard Error 1.49
|
0 mg/dl
Standard Error .34
|
|
Lipid Profile
HDL-C
|
0 mg/dl
Standard Error .17
|
-1 mg/dl
Standard Error .23
|
-1 mg/dl
Standard Error .39
|
|
Lipid Profile
Triglycerides
|
4 mg/dl
Standard Error 1.52
|
-2 mg/dl
Standard Error 3.91
|
35 mg/dl
Standard Error 4
|
|
Lipid Profile
non-HDL
|
-4 mg/dl
Standard Error 1.87
|
-4 mg/dl
Standard Error 1.45
|
3 mg/dl
Standard Error .53
|
|
Lipid Profile
Lp (a)
|
0 mg/dl
Standard Error .11
|
0 mg/dl
Standard Error 4.69
|
1 mg/dl
Standard Error .08
|
|
Lipid Profile
VLDL
|
-1 mg/dl
Standard Error .13
|
1 mg/dl
Standard Error .17
|
3 mg/dl
Standard Error .1
|
SECONDARY outcome
Timeframe: Week 8All events reported that were deemed to be related, or unrelated, to the study drug.
Outcome measures
| Measure |
Statin and Policosanol
n=18 Participants
20mg daily, double-blind
|
Statin and Placebo
n=18 Participants
20mg daily, double-blind
|
Policosanol
n=18 Participants
20 mg daily, open label
|
|---|---|---|---|
|
Adverse Events Reported
|
6 number of events reported
|
10 number of events reported
|
5 number of events reported
|
Adverse Events
Statin and Policosanol
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Statin and Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Policosanol
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Statin and Policosanol
n=18 participants at risk
20mg daily, double-blind
|
Statin and Placebo
n=18 participants at risk
20mg daily, double-blind
|
Policosanol
n=18 participants at risk
20 mg daily, open label
|
|---|---|---|---|
|
General disorders
Head cold
|
11.1%
2/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
16.7%
3/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
16.7%
3/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
5.6%
1/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
0.00%
0/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
|
General disorders
Hip pain
|
0.00%
0/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
5.6%
1/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
0.00%
0/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
5.6%
1/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
0.00%
0/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
|
General disorders
Aftertaste
|
0.00%
0/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
5.6%
1/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
0.00%
0/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
|
General disorders
Leg cramps
|
0.00%
0/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
5.6%
1/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
0.00%
0/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
|
General disorders
Fever
|
0.00%
0/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
5.6%
1/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
0.00%
0/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
|
General disorders
Flank pain
|
0.00%
0/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
5.6%
1/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
0.00%
0/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
|
Reproductive system and breast disorders
Breast cancer
|
5.6%
1/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
0.00%
0/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
0.00%
0/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
|
General disorders
Pulled hamstring
|
5.6%
1/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
0.00%
0/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
0.00%
0/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
|
Gastrointestinal disorders
constipation
|
5.6%
1/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
0.00%
0/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
0.00%
0/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
|
General disorders
Headache
|
5.6%
1/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
0.00%
0/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
5.6%
1/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
|
General disorders
Transient dizziness
|
0.00%
0/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
0.00%
0/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
5.6%
1/18 • Adverse events were collected over the course of the study using subject reports and questionnaires.
Other events include all reported events, whether or not they were deemed to be related to the study drug.
|
Additional Information
James Backes, PharmD
University of Kansas Medical Center
Phone: (913) 588-5324
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place