An interventional study of Fenofibrate 54mg in Hyperlipidemias, sponsored by Kaiser Permanente. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-08.
Sponsored by Kaiser Permanente · Not applicable, Interventional, and Treatment
The primary objective of this randomized trial is to measure the impact of converting patients on statin therapy from fenofibrate 160mg to 54mg per day compared to patients who continue fenofibrate 160mg per day for triglycerides.
Hypothesis: Study subjects receiving fenofibrate 54mg will maintain similar triglyceride levels as patients on 160mg of fenofibrate.
The primary objective of this randomized trial is to measure the impact of converting patients on statin therapy from fenofibrate 160mg to 54mg per day compared to patients who continue fenofibrate 160mg per day for triglycerides. Secondary objectives include evaluating effect of the dosage change on low-density lipoprotein (LDL), HDL, alanine aminotransferase (ALT), aspartate aminotransferase (AST), and serum creatinine (SCr), and the potential cost savings associated with prescribing 54mg instead of 160mg. Electronic medical records will be used to identify subjects and gather data on demographics, comorbid conditions, and concomitant lipid lowering therapy. Subjects will be recruited for enrollment via telephone by the principal investigator (PI), co-principal investigators (Co-PIs), or provider referral after eligibility screening and approval from their primary care physician. Subjects must provide written informed consent and Health Insurance Privacy and Accountability Act (HIPAA) privacy rule authorization prior to participation in this study. Subjects will be randomized to either the intervention arm (conversion to 54mg of fenofibrate) or to the control arm (remain on 160mg of fenofibrate). Subjects in both study arms will have fasting lipid panels, ALT/AST, and SCr evaluated at baseline. All subjects will have repeat labs approximately 8 weeks after enrollment. All subjects will continue to receive standard care based on lipid values. The study period will begin approximately October 29, 2010 and run to June 30, 2011.
820 studies on the registry are indexed under Hyperlipidemias; 105 are open to participants now.
This study's enrollment of 66 is below the median of 88 across 691 interventional studies indexed under Hyperlipidemias.
Browse Hyperlipidemias studies →Kaiser Permanente is the lead sponsor of 385 studies on the registry; 41 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.
Drug: Fenofibrate 54mg
Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
Subjects will receive fenofibrate 54mg daily.
Triglyceride Levels
Triglyceride levels will be assessed in study participants 6-10 weeks after entry into study.
Time frame: 6-10 weeks
Low-density Lipoprotein (LDL)
LDL levels will be assessed in study participants 6-10 weeks after entry into study.
Time frame: 6-10 weeks
High-density Lipoprotein,(HDL)
HDL levels will be assessed in study participants 6-10 weeks after entry into study.
Time frame: 6-10 weeks
Alanine Aminotransferase(ALT)
ALT levels will be assessed in study participants 6-10 weeks after entry into study.
Time frame: 6-10 weeks
Aspartate Aminotransferase (AST)
AST levels will be assessed in study participants 6-10 weeks after entry into study.
Time frame: 6-10 weeks
Serum Creatinine(SCr)
SCr levels will be assessed in study participants 6-10 weeks after entry into study.
Time frame: 6-10 weeks
| Milestone | Intervention | Control |
|---|---|---|
| Started | 33 | 33 |
| Subjects meeting all inclusion criteria | 25 | 29 |
| Completed | 24 | 28 |
| Not completed | 9 | 5 |
Triglyceride levels will be assessed in study participants 6-10 weeks after entry into study.
| milligram/deciliter | Intervention | Control |
|---|---|---|
| Baseline Triglyceride Levels | 135.5 ± 36.22 | 108.3 ± 37.41 |
| Follow-Up Triglyceride Levels | 152.7 ± 42.61 | 109 ± 39.70 |
LDL levels will be assessed in study participants 6-10 weeks after entry into study.
| milligram/deciliter | Intervention | Control |
|---|---|---|
| Baseline Low-density lipoprotein | 95.32 ± 21.32 | 83.29 ± 22.99 |
| Follow-up Low-density lipoprotein | 84.42 ± 21.05 | 78.71 ± 21.93 |
HDL levels will be assessed in study participants 6-10 weeks after entry into study.
| milligram/deciliter | Intervention | Control |
|---|---|---|
| Baseline High-density lipoprotein | 41.88 ± 9.58 | 41.79 ± 14.24 |
| Follow-up High-density lipoprotein | 43.21 ± 38.99 | 38.79 ± 33.61 |
ALT levels will be assessed in study participants 6-10 weeks after entry into study.
| international units/liter | Intervention | Control |
|---|---|---|
| Baseline Alanine aminotransferase | 29.76 ± 26.20 | 30.66 ± 26.61 |
| Follow-up Alanine aminotransferase | 27.38 ± 9.13 | 29.96 ± 11.03 |
AST levels will be assessed in study participants 6-10 weeks after entry into study.
| international units/liter | Intervention | Control |
|---|---|---|
| Baseline Aspartate Aminotransferase | 27.48 ± 6.14 | 27.59 ± 8.57 |
| Follow-up Aspartate Aminotransferase | 25.5 ± 5.41 | 26.36 ± 6.49 |
SCr levels will be assessed in study participants 6-10 weeks after entry into study.
| milligram/deciliter | Intervention | Control |
|---|---|---|
| Baseline Serum Creatinine | 0.9880 ± 0.2571 | 1.14 ± 0.24 |
| Follow-up Serum Creatinine | 1 ± 0.23 | 1.13 ± 0.23 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | — | 0/25 (0%) | 0/25 (0%) |
| Control | — | 0/29 (0%) | 0/29 (0%) |
| Age, Continuous(years) | Intervention | Control | Total |
|---|---|---|---|
| Mean | 57.2 ± 8.67 | 57.55 ± 9.26 | 57.41 ± 8.36 |
| Sex: Female, Male(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Female | 8 | 7 | 15 |
| Male | 17 | 22 | 39 |
| Race (NIH/OMB)(Participants) | Intervention | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 22 | 25 | 47 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 3 | 5 |
| Region of Enrollment(participants) | Intervention | Control | Total |
|---|---|---|---|
| United States | 25 | 29 | 54 |
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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