Fenofibrate and Omega-3 Fatty Acid Modulation of Endotoxemia (FFAME)

This study has been completed.
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
GlaxoSmithKline
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01048502
First received: January 11, 2010
Last updated: January 21, 2016
Last verified: January 2016
Results First Received: July 29, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Basic Science
Condition: Cardiovascular Disease
Interventions: Drug: Fenofibrate (Tricor) tablets
Drug: Placebo
Drug: Lovaza

  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
100 subjects were enrolled; 80 completed the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Fenofibrate (Tricor) (145 mg/Day)

Participants will be given 1 fenofibrate (Tricor) 145mg and 4 fish oil placebos - supplies of study drug will be provided to last 8 weeks.

Fenofibrate (Tricor) tablets: One 145 mg tablet taken once daily, in the evening, with food, for 6 to 8 weeks

Placebo

Participants will be given 5 placebo pills (4 fish oil placebo and 1 Fenofibrate placebo) - supplies of study drug will be provided to last 8 weeks.

Placebo: Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks

Lovaza (900 mg/Day)

Participants will be given 1 Lovaza capsule, 3 Fish oil placebo capsules, and 1 Fenofibrate placebo – supplies of study drug will be provided to last 8 weeks.

Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks.

Lovaza (3,600 mg/Day)

Participants will be given 4 Lovaza capsules and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.

Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks.


Participant Flow:   Overall Study
    Fenofibrate (Tricor) (145 mg/Day)     Placebo     Lovaza (900 mg/Day)     Lovaza (3,600 mg/Day)  
STARTED     24     23     28     25  
COMPLETED     20     16     23     21  
NOT COMPLETED     4     7     5     4  
Lost to Follow-up                 2                 0                 0                 0  
Adverse Event                 1                 0                 0                 0  
Withdrawal by Subject                 1                 4                 5                 3  
Physician Decision                 0                 3                 0                 1  



  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
Fenofibrate (Tricor) (145 mg/Day)

Participants will be given 1 fenofibrate (Tricor) 145mg and 4 fish oil placebos - supplies of study drug will be provided to last 8 weeks.

Fenofibrate (Tricor)tablets: One 145 mg tablet taken once daily, in the evening, with food, for 6 to 8 weeks

Placebo

Participants will be given 5 placebo pills (4 fish oil placebo and 1 Fenofibrate placebo) - supplies of study drug will be provided to last 8 weeks.

Placebo: Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks

Lovaza (900 mg/Day)

Participants will be given 1 Lovaza capsule, 3 Fish oil placebo capsules, and 1 Fenofibrate placebo – supplies of study drug will be provided to last 8 weeks.

Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks.

Lovaza (3,600 mg/Day)

Participants will be given 4 Lovaza capsules and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.

Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks.

Total Total of all reporting groups

Baseline Measures
    Fenofibrate (Tricor) (145 mg/Day)     Placebo     Lovaza (900 mg/Day)     Lovaza (3,600 mg/Day)     Total  
Number of Participants  
[units: participants]
  24     23     28     25     100  
Age  
[units: years]
Mean (Full Range)
  25.58  
  (21 to 43)  
  25.96  
  (18 to 43)  
  26.68  
  (18 to 42)  
  24.68  
  (19 to 36)  
  25.75  
  (18 to 43)  
Gender  
[units: participants]
         
Female     11     12     12     12     47  
Male     13     11     16     13     53  
Race (NIH/OMB)  
[units: participants]
         
American Indian or Alaska Native     0     0     0     0     0  
Asian     3     5     3     4     15  
Native Hawaiian or Other Pacific Islander     0     0     0     0     0  
Black or African American     5     4     8     5     22  
White     16     14     17     16     63  
More than one race     0     0     0     0     0  
Unknown or Not Reported     0     0     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Effect of Omega-3 Fatty Acid Supplementation on Cytokine Production (Plasma Levels of TNFα) During an in Vivo Inflammatory Challenge (LPS).   [ Time Frame: randomization and 8 weeks post ]

2.  Secondary:   Changes in Inflammatory Parameter (Plasma TNF-α Levels) After Treatment With Fenofibrate or Placebo.   [ Time Frame: baseline and 6-8 weeks ]


  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
No text entered.


  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: Muredach Reilly
Organization: UPenn
phone: 215-573-1214
e-mail: muredach@mail.med.upenn.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01048502     History of Changes
Other Study ID Numbers: 810598
P50HL083799 ( US NIH Grant/Contract Award Number )
Study First Received: January 11, 2010
Results First Received: July 29, 2015
Last Updated: January 21, 2016
Health Authority: United States: Food and Drug Administration