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Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis

This study has been completed.
Sponsor:
Collaborators:
American Heart Association
American College of Clinical Pharmacy
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00361283
First received: August 4, 2006
Last updated: April 16, 2012
Last verified: April 2012
Results First Received: March 9, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Screening
Condition: Inflammation
Intervention: Drug: Atorvastatin

  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
University of Florida Clinical Research Center. Study started June 2004 and ended January 9, 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Atorvastatin 80mg of atorvastatin given once daily for 16 weeks

Participant Flow:   Overall Study
    Atorvastatin  
STARTED     108  
COMPLETED     81  
NOT COMPLETED     27  
Lost to Follow-up                 27  



  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.
No text entered.

Reporting Groups
  Description
Atorvastatin 80mg of atorvastatin given once daily for 16 weeks

Baseline Measures
    Atorvastatin  
Number of Participants  
[units: participants]
  108  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     107  
>=65 years     1  
Age  
[units: years]
Mean ± Standard Deviation
  31.6  ± 12.6  
Gender  
[units: participants]
 
Female     66  
Male     42  
Region of Enrollment  
[units: participants]
 
United States     108  



  Outcome Measures

1.  Primary:   Mean Change in Level: Week 16-baseline in Ena-78   [ Time Frame: 16 weeks after baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Reginald F. Frye, PhD, Associate Professor
Organization: University of Florida
phone: 3522735453
e-mail: fryerf@ufl.edu


No publications provided


Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00361283     History of Changes
Other Study ID Numbers: 0435278B
Study First Received: August 4, 2006
Results First Received: March 9, 2012
Last Updated: April 16, 2012
Health Authority: United States: Institutional Review Board