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

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ClinicalTrials.gov Identifier: NCT01048502
Recruitment Status : Completed
First Posted : January 13, 2010
Results First Posted : February 19, 2016
Last Update Posted : February 19, 2016
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
GlaxoSmithKline
Information provided by (Responsible Party):
University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Basic Science
Condition Cardiovascular Disease
Interventions Drug: Fenofibrate (Tricor) tablets
Drug: Placebo
Drug: Lovaza
Enrollment 100
Recruitment Details 100 subjects were enrolled; 80 completed the study.
Pre-assignment Details  
Arm/Group Title Fenofibrate (Tricor) (145 mg/Day) Placebo Lovaza (900 mg/Day) Lovaza (3,600 mg/Day)
Hide Arm/Group Description

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

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

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.

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.

Period Title: Overall Study
Started 24 23 28 25
Completed 20 16 23 21
Not Completed 4 7 5 4
Reason Not Completed
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
Arm/Group Title Fenofibrate (Tricor) (145 mg/Day) Placebo Lovaza (900 mg/Day) Lovaza (3,600 mg/Day) Total
Hide Arm/Group Description

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

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

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.

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 of all reporting groups
Overall Number of Baseline Participants 24 23 28 25 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 24 participants 23 participants 28 participants 25 participants 100 participants
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)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 23 participants 28 participants 25 participants 100 participants
Female
11
  45.8%
12
  52.2%
12
  42.9%
12
  48.0%
47
  47.0%
Male
13
  54.2%
11
  47.8%
16
  57.1%
13
  52.0%
53
  53.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 23 participants 28 participants 25 participants 100 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
  12.5%
5
  21.7%
3
  10.7%
4
  16.0%
15
  15.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
  20.8%
4
  17.4%
8
  28.6%
5
  20.0%
22
  22.0%
White
16
  66.7%
14
  60.9%
17
  60.7%
16
  64.0%
63
  63.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title The Effect of Omega-3 Fatty Acid Supplementation on Cytokine Production (Plasma Levels of TNFα) During an in Vivo Inflammatory Challenge (LPS).
Hide Description [Not Specified]
Time Frame randomization and 8 weeks post
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Lovaza (900 mg/Day) Lovaza (3,600 mg/Day)
Hide Arm/Group Description:

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

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.

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.

Overall Number of Participants Analyzed 16 23 21
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
TNF-α at randomization
0.95
(0.8 to 1.68)
1.26
(0.72 to 1.76)
1.14
(0.76 to 1.81)
TNF-α 8 weeks post randomization
1.12
(0.64 to 1.84)
1.25
(0.78 to 1.76)
0.99
(0.64 to 1.34)
2.Secondary Outcome
Title Changes in Inflammatory Parameter (Plasma TNF-α Levels) After Treatment With Fenofibrate or Placebo.
Hide Description [Not Specified]
Time Frame baseline and 6-8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fenofibrate (Tricor) (145 mg/Day) Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 20 16
Median (Standard Deviation)
Unit of Measure: pg/mL
TNF-α at randomization 1.2  (0.5) 1.5  (1.2)
TNF-α 6-8 weeks post randomization 1.1  (0.4) 0.2  (1.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tricor (145 mg/Day) Placebo Lovaza (900 mg/Day) Lovaza (3,600 mg/Day)
Hide Arm/Group Description

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

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

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

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.

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.

All-Cause Mortality
Tricor (145 mg/Day) Placebo Lovaza (900 mg/Day) Lovaza (3,600 mg/Day)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Tricor (145 mg/Day) Placebo Lovaza (900 mg/Day) Lovaza (3,600 mg/Day)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/23 (0.00%)      0/28 (0.00%)      0/25 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Tricor (145 mg/Day) Placebo Lovaza (900 mg/Day) Lovaza (3,600 mg/Day)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/24 (16.67%)      3/23 (13.04%)      8/28 (28.57%)      8/25 (32.00%)    
Blood and lymphatic system disorders         
> 2g drop in Hgb from baseline   1/24 (4.17%)  1 1/23 (4.35%)  1 4/28 (14.29%)  4 1/25 (4.00%)  1
General disorders         
cold/allergy symptoms  [1]  3/24 (12.50%)  3 2/23 (8.70%)  2 4/28 (14.29%)  4 7/25 (28.00%)  7
Indicates events were collected by systematic assessment
[1]
Subjects reported having illnesses that were unrelated to study but that occurred during participation.
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
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01048502     History of Changes
Other Study ID Numbers: 810598
P50HL083799 ( U.S. NIH Grant/Contract )
First Submitted: January 11, 2010
First Posted: January 13, 2010
Results First Submitted: July 29, 2015
Results First Posted: February 19, 2016
Last Update Posted: February 19, 2016