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


  Baseline Characteristics
  Hide Baseline Characteristics

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
  Show All Outcome Measures

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information