Phase 4
N=506
A Study to Evaluate Fenofibrate Combination With Statin in Chinese Patients With Dyslipidemic
Dyslipidemias · Cardiovascular Diseases · Hypertriglyceridemia
Bottom Line
View on ClinicalTrials.gov: NCT01462877 ↗Enrolled (actual)
506
Serious AEs
1.4%
Results posted
Feb 2015
Primary outcome: Primary: Percentage of Triglyceride (TG) Change — -38.12 percentage of TG change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- fenofibrate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Triglyceride (TG) Change |
-38.12 | — |
| SECONDARY Change in Serum Total Cholesterol |
2.75 | — |
| SECONDARY Change in Serum Low-density Lipoprotein Cholesterol |
14.91 | — |
| SECONDARY Change in Serum High-density Lipoprotein Cholesterol |
17.40 | — |
| SECONDARY Change in Serum Non-high-density Lipoprotein Cholesterol |
-1.30 | — |
| SECONDARY Change in Serum Apolipoprotein A1 |
12.41 | — |
| SECONDARY Change in Serum Apolipoprotein B |
2.42 | — |
| SECONDARY Change in Serum Alanine Aminotransferase |
0.00 | — |
| SECONDARY Change in Serum Aspartate Aminotransferase |
10.91 | — |
| SECONDARY Change in Serum Creatine Kinase |
8.02 | — |
| SECONDARY Change in Serum Creatinine |
12.99 | — |
| SECONDARY Change in Serum High Sensitivity C-reactive Protein |
— | — |
Summary
Atherogenic dyslipidemia includes patients who have coronary heart disease (CHD) or CHD risk equivalents, whose TG level is not adequately controlled after statin monotherapy. According to the published ESC/EAS consensus, fibrate is suggested to be added to this type of patient who has insufficient improvement. The purpose of the study is to evaluate the efficacy on lipid control and the safety of adding fenofibrate in patients on a background of statin treatment.
Eligibility Criteria
Inclusion Criteria
- ≥18 years and 20%.
- ≥ 2 months statin monotherapy with standard dose (atorvastatin ≤20mg q.d. or rosuvastatin ≤10mg q.d. or simvastatin ≤40mg q.d. or pravastatin ≤40mg q.d. or pitavastatin ≤4mg q.d or fluvastatin ≤80mg q.d. or lovastatin ≤40mg q.d.) and plan to continue the previous type and dose of statin
- Triglycerides (TG)≥1.70 mmol/L (150mg/dl) and TG 2ULN (upper limit of normal)]
- Renal insufficiency [Creatinine clearance rate (Ccr) 2 ULN
- Congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency
- Hypothyroidism
- Combination use of other non-statin lipid-regulating drugs such as fibrates, niacin and fish oil in previous 2 months
- Combination use of drug with similar structure as Fenofibrate, especially ketoprofen
- Combination use of oral anticoagulants
- Pregnant or lactating woman
- Other conditions at investigator's discretion
Data sourced from ClinicalTrials.gov (NCT01462877). 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.