Preliminary Study of Safety and Efficacy of Policosanol

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara Swanson, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT00312923
First received: April 7, 2006
Last updated: July 19, 2013
Last verified: July 2013
Results First Received: May 23, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Dyslipidemia
HIV Infections
Interventions: Drug: Policosanol
Dietary Supplement: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Treatment Group     Control Group  
STARTED     28     26  
COMPLETED     19     20  
NOT COMPLETED     9     6  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
54 eligible participants were randomized to the study arms. 39 participants completed the study. An intent-to-treat analysis was performed.

Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
    Treatment Group     Control Group     Total  
Number of Participants  
[units: participants]
  28     26     54  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     28     26     54  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  44.6  ± .54     46.8  ± 6.56     44.67  ± 6.04  
Gender  
[units: participants]
     
Female     7     8     15  
Male     21     18     39  
Region of Enrollment  
[units: participants]
     
United States     28     26     54  



  Outcome Measures
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1.  Primary:   LDL Cholesterol   [ Time Frame: 12 weeks ]

Measure Type Primary
Measure Title LDL Cholesterol
Measure Description Low density lipoprotein cholesterol
Time Frame 12 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Measured Values
    Treatment Group     Control Group  
Number of Participants Analyzed  
[units: participants]
  27     27  
LDL Cholesterol  
[units: mg/dl]
Mean ± Standard Deviation
  116.34  ± 37.75     118.84  ± 38.38  

No statistical analysis provided for LDL Cholesterol



2.  Secondary:   Triglycerides   [ Time Frame: 12 weeks ]

Measure Type Secondary
Measure Title Triglycerides
Measure Description No text entered.
Time Frame 12 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Measured Values
    Treatment Group     Control Group  
Number of Participants Analyzed  
[units: participants]
  27     27  
Triglycerides  
[units: mg/dl]
Mean ± Standard Deviation
  173.73  ± 200.39     186.69  ± 125.60  

No statistical analysis provided for Triglycerides




  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
It is possible that other constituents underlie policosanol’s lipid-lowering activity. One study found that triacontanol inhibited HMG-CoA reductase in rat liver cells. Triacontanol was not detected in either lot of policosanol used in this study.  


Results Point of Contact:  
Name/Title: Barbara Swanson
Organization: Rush University Medical Center
phone: 312-942-8977
e-mail: barbara_a_swanson@rush.edu


No publications provided


Responsible Party: Barbara Swanson, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00312923     History of Changes
Other Study ID Numbers: R21 AT003077-01, R21AT003077-01
Study First Received: April 7, 2006
Results First Received: May 23, 2013
Last Updated: July 19, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration