Trial Outcomes & Findings for Preliminary Study of Safety and Efficacy of Policosanol (NCT NCT00312923)

Results Overview

Low density lipoprotein cholesterol

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

54 participants

Primary outcome timeframe

12 weeks

Results posted on

2013-07-26

Participant Flow

The study was conducted between April, 2006 and July, 2009 at three inner-city outpatient HIV/AIDS clinics located in a Chicago neighborhood that has been designated as medically underserved by the Health Resources Service Administration (HRSA).

A total of 176 participants were screened for eligibility and 54 were randomized and entered into the intent-to-treat analyses. Most of the ineligible participants did not meet the study's lipid criteria

Participant milestones

Participant milestones
Measure	Treatment Group 20 mg daily of policosanol Policosanol : 20 mg of policosanol in capsular form daily	Control Group Placebo : Two capsules of 10 mg of microcrystalline cellulose daily
Overall Study STARTED	28	26
Overall Study COMPLETED	19	20
Overall Study NOT COMPLETED	9	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Preliminary Study of Safety and Efficacy of Policosanol

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group n=28 Participants 20 mg daily of policosanol Policosanol : 20 mg of policosanol in capsular form daily	Control Group n=26 Participants Placebo : Two capsules of 10 mg of microcrystalline cellulose daily	Total n=54 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants	26 Participants n=7 Participants	54 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	44.6 years STANDARD_DEVIATION .54 • n=5 Participants	46.8 years STANDARD_DEVIATION 6.56 • n=7 Participants	44.67 years STANDARD_DEVIATION 6.04 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	18 Participants n=7 Participants	39 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants	26 participants n=7 Participants	54 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Low density lipoprotein cholesterol

Outcome measures

Outcome measures
Measure	Treatment Group n=27 Participants 20 mg daily of policosanol Policosanol : 20 mg of policosanol in capsular form daily	Control Group n=27 Participants Placebo : Two capsules of 10 mg of microcrystalline cellulose daily
LDL Cholesterol	116.34 mg/dl Standard Deviation 37.75	118.84 mg/dl Standard Deviation 38.38

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	Treatment Group n=27 Participants 20 mg daily of policosanol Policosanol : 20 mg of policosanol in capsular form daily	Control Group n=27 Participants Placebo : Two capsules of 10 mg of microcrystalline cellulose daily
Triglycerides	173.73 mg/dl Standard Deviation 200.39	186.69 mg/dl Standard Deviation 125.60

Adverse Events

Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Barbara Swanson

Rush University Medical Center

Phone: 312-942-8977

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place