Clinical trial NCT01462877: A Study to Evaluate Fenofibrate Combination With Statin in Chinese Patients With Dyslipidemic
Official title: An Open-label, Multi-center Study to Evaluate the Efficacy and Safety of Statin-fenofibrate Combination Therapy in Dyslipidemic Chinese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dyslipidemias
Cardiovascular Diseases
Hypertriglyceridemia
Keywords: Lipid Regulating Agents
Drug Therapy
cardiovascular diseases
hypertriglyceridemia
Hydroxymethylglutaryl-CoA Reductase Inhibitors
fenofibrate
Dyslipidemias
Combination
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Rundo International Pharmaceutical Research & Development Co.,Ltd.
First posted: 2011-11-01
Enrollment: 506
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: It is an open-label , single group, multi-center study. At around 30 investigate sites, 500 dyslipidemic Chinese patients with coronary heart disease (CHD) or CHD risk equivalent, whose TG ≥1.70 mmol/L (150mg/dl) and \<5.65mmol/L (500mg/dl) after at least 2 month statin monotherapy with standard dose will be enrolled. After at least 2 month statin monotherapy with standard dose, patients having high TG will be recruited and given statin-fenofibrate combination therapy for 8 weeks. Several lipid parameters and safety parameters will be compared between baseline, after 4 weeks treatment and after 8 weeks treatment. Primary efficacy endpoint is the percentage of TG decrease before and after 8 weeks treatment. Secondary endpoints on efficacy are the absolute change and the percent of change on TC, LDL-C, HDL-C, apoA1, apoB and apoB/apoA1 of baseline, after 4 weeks treatment and 8 weeks treatment, absolute change and percentage of change of hsCRP from baseline to 8 weeks of treatment. Second endpoints on safety is the incidence of AE/SAE, change on CK, ALT, AST, BUN and Cr before and after treatment and the number of clinical meaningful abnormal change defined as ALT or AST \>3ULN, or CK \>10ULN, or BUN \>1.5ULN or Cr \>1.5ULN. Other Arm type is a self comparator

Eligibility criteria: Inclusion Criteria:

1. ≥18 years and \< 80 years, male or female
2. With at least one risk of coronary heart disease (CHD) \[medical history of myocardial infarction (MI) or coronary angiography shows coronary stenosis ≥ 50% or post percutaneous coronary intervention (PCI) or post coronary artery bypass grafting (CABG)\] or CHD risk equivalents, which comprise,

   * Other clinical forms of atherosclerotic disease (ischemic stroke, peripheral arterial disease, abdominal aortic aneurysm, and symptomatic carotid artery disease)
   * Type 2 Diabetes
   * Multiple risk factors that confer a 10-year risk for CHD \>20%.
3. ≥ 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
4. Triglycerides (TG)≥1.70 mmol/L (150mg/dl) and TG\<5.65 mmol/L (500mg/dl)
5. Subject must be able to provide informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), on his or her own behalf, prior to any study-specific procedures.

Exclusion Criteria:

1. Hypersensitive to fenofibrate or to any of its excipients
2. Hepatic insufficiency \[alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2ULN (upper limit of normal)\]
3. Renal insufficiency \[Creatinine clearance rate (Ccr)\<60ml/min estimated from Cockcroft-Gault equation Ccr=(140-age)\*weight(Kg)\*0.85(if female)/\[0.818\*Cr (µmol/L)\]
4. Creatine kinase (CK) \> 2 ULN
5. Congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency
6. Hypothyroidism
7. Combination use of other non-statin lipid-regulating drugs such as fibrates, niacin and fish oil in previous 2 months
8. Combination use of drug with similar structure as Fenofibrate, especially ketoprofen
9. Combination use of oral anticoagulants
10. Pregnant or lactating woman
11. Other conditions at investigator's discretion

Primary outcomes:
measure: Percentage of Triglyceride (TG) Change
timeFrame: Baseline and up to 8 weeks after intervention
Secondary outcomes:
measure: Change in Serum Total Cholesterol
timeFrame: Baseline and up to 8 weeks after intervention
measure: Change in Serum Low-density Lipoprotein Cholesterol
timeFrame: Baseline up to 8 weeks after intervention
measure: Change in Serum High-density Lipoprotein Cholesterol
timeFrame: Baseline up to 8 weeks after intervention
measure: Change in Serum Non-high-density Lipoprotein Cholesterol
timeFrame: Baseline up to 8 weeks after intervention
measure: Change in Serum Apolipoprotein A1
timeFrame: Baseline up to 8 weeks after intervention
measure: Change in Serum Apolipoprotein B
timeFrame: Baseline up to 8 weeks after intervention
measure: Change in Serum Alanine Aminotransferase
timeFrame: Baseline up to 8 weeks after intervention
measure: Change in Serum Aspartate Aminotransferase
timeFrame: Baseline up to 8 weeks after intervention
measure: Change in Serum Creatine Kinase
timeFrame: Baseline up to 8 weeks after intervention
measure: Change in Serum Creatinine
timeFrame: Baseline up to 8 weeks after intervention
measure: Change in Serum High Sensitivity C-reactive Protein
timeFrame: Baseline and up to 8 weeks after intervention
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Site Reference ID/Investigator# 64695
Study officials:
affiliation: Abbott
name: Lyra Xie, MD
role: STUDY_CHAIR
References: