A Study to Evaluate Fenofibrate Combination With Statin in Chinese Patients With Dyslipidemic

An Open-label, Multi-center Study to Evaluate the Efficacy and Safety of Statin-fenofibrate Combination Therapy in Dyslipidemic Chinese Patients

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Dyslipidemias; Hypertriglyceridemia
• Intervention / Treatment: Drug: fenofibrate

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

• Study Type: Interventional
• Enrollment (Actual): 506
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Xiamen, China, 36100
    • Site Reference ID/Investigator# 64695

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Fenofibrate arm	Drug: fenofibrate; Fenofibrate Capsule 200mg qd orally; Other Names: ABT-799; lipanthyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Triglyceride (TG) Change	Blood tests	Baseline and up to 8 weeks after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Serum Total Cholesterol	Blood tests	Baseline and up to 8 weeks after intervention
Change in Serum Low-density Lipoprotein Cholesterol	Blood tests	Baseline up to 8 weeks after intervention
Change in Serum High-density Lipoprotein Cholesterol	Blood tests	Baseline up to 8 weeks after intervention
Change in Serum Non-high-density Lipoprotein Cholesterol	Blood tests	Baseline up to 8 weeks after intervention
Change in Serum Apolipoprotein A1	Blood tests	Baseline up to 8 weeks after intervention
Change in Serum Apolipoprotein B	Blood tests	Baseline up to 8 weeks after intervention
Change in Serum Alanine Aminotransferase	Blood tests	Baseline up to 8 weeks after intervention
Change in Serum Aspartate Aminotransferase	Blood tests	Baseline up to 8 weeks after intervention
Change in Serum Creatine Kinase	Blood tests	Baseline up to 8 weeks after intervention
Change in Serum Creatinine	Blood tests	Baseline up to 8 weeks after intervention
Change in Serum High Sensitivity C-reactive Protein	Blood tests	Baseline and up to 8 weeks after intervention

Collaborators and Investigators

• Sponsor: Abbott
• Collaborators: Rundo International Pharmaceutical Research & Development Co.,Ltd.
• Investigators: Study Chair: Lyra Xie, MD, Abbott

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: October 28, 2011
• First Submitted That Met QC Criteria: October 28, 2011
• First Posted (Estimate): November 1, 2011

Study Record Updates

• Last Update Posted (Estimate): March 17, 2015
• Last Update Submitted That Met QC Criteria: February 25, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Drug Therapy; cardiovascular diseases; hypertriglyceridemia; Combination; fenofibrate; Dyslipidemias; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Lipid Regulating Agents
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Cardiovascular Diseases; Dyslipidemias; Hypertriglyceridemia; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Hypolipidemic Agents; Lipid Regulating Agents; Fenofibrate
• Other Study ID Numbers: W13-254