N/A
Completed N=66
Effect of Fenofibrate Conversion on Triglyceride Levels in Patients on Statin Therapy
Source: ClinicalTrials.gov NCT01280604 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcomePrimary: Triglyceride Levels — 135.5; 108.3; 152.7; 109 milligram/deciliter
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Triglyceride Levels |
135.5; 108.3; 152.7; 109 | — |
| SECONDARY Low-density Lipoprotein (LDL) |
95.32; 83.29; 84.42; 78.71 | — |
| SECONDARY High-density Lipoprotein,(HDL) |
41.88; 41.79; 43.21; 38.79 | — |
| SECONDARY Alanine Aminotransferase(ALT) |
29.76; 30.66; 27.38; 29.96 | — |
| SECONDARY Aspartate Aminotransferase (AST) |
27.48; 27.59; 25.5; 26.36 | — |
| SECONDARY Serum Creatinine(SCr) |
0.9880; 1.14; 1; 1.13 | — |
Eligibility Criteria
Inclusion Criteria
- Adults 18 years of age or older
- Patients actively taking fenofibrate 160mg and statin therapy
- A fasting lipid panel within the past 9 months with most recent triglycerides levels less than 200mg/dL
- Primary care physician approves participation and fenofibrate conversion
Exclusion Criteria
- Impaired renal function defined as creatine clearance ≤ 50ml/min
- Current enrollment in other studies or clinical trials
- Previous fenofibrate 54mg use
- A history of pancreatitis or known previous triglyceride levels >1000mg/dL
- Pregnancy
- Members with plan benefits that include a deductible for lab services at Kaiser Permanente
Data sourced from ClinicalTrials.gov (NCT01280604). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.