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

NCT01462877 | Completed Phase 4 Results

• 1 other identifier: W13-254
• Study Type: interventional
• Target: 506
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyslipidemias; Cardiovascular Diseases; Hypertriglyceridemia

Keywords

Lipid Regulating Agents; Drug Therapy; cardiovascular diseases; hypertriglyceridemia; Hydroxymethylglutaryl-CoA Reductase Inhibitors; fenofibrate; Dyslipidemias; Combination

Outcome Measures

Primary Outcomes (1)

• Percentage of Triglyceride (TG) Change

  Blood tests

  Baseline and up to 8 weeks after intervention

Secondary Outcomes (11)

• Change in Serum Total Cholesterol

  Baseline and up to 8 weeks after intervention

• Change in Serum Low-density Lipoprotein Cholesterol

  Baseline up to 8 weeks after intervention

• Change in Serum High-density Lipoprotein Cholesterol

  Baseline up to 8 weeks after intervention

• Change in Serum Non-high-density Lipoprotein Cholesterol

  Baseline up to 8 weeks after intervention

• Change in Serum Apolipoprotein A1

  Baseline up to 8 weeks after intervention

Study Arms (1)

Fenofibrate arm

OTHER

Drug: fenofibrate

Interventions

fenofibrate DRUG

Fenofibrate Capsule 200mg qd orally

Also known as: ABT-799, lipanthyl

Fenofibrate arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years and \< 80 years, male or female
• 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%.
• ≥ 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\<5.65 mmol/L (500mg/dl)
• 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.

You may not qualify if:

• Hypersensitive to fenofibrate or to any of its excipients
• Hepatic insufficiency \[alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2ULN (upper limit of normal)\]
• Renal insufficiency \[Creatinine clearance rate (Ccr)\<60ml/min estimated from Cockcroft-Gault equation Ccr=(140-age)\*weight(Kg)\*0.85(if female)/\[0.818\*Cr (µmol/L)\]
• Creatine kinase (CK) \> 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

Sponsors & Collaborators

• Abbott: lead
• Rundo International Pharmaceutical Research & Development Co.,Ltd.: collaborator

Study Sites (1)

Site Reference ID/Investigator# 64695

Xiamen, 36100, China

Location

MeSH Terms

Conditions

Dyslipidemias; Cardiovascular Diseases; Hypertriglyceridemia

Interventions

Fenofibrate

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperlipidemias

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones

Results Point of Contact

• Title: Associate Director Clinical Services
• Organization: Abbott

taco.baardman@abbott.com

Study Officials

• Lyra Xie, MD

  Abbott

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2011
• First Posted: November 1, 2011
• Study Start: October 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 17, 2015
• Results First Posted: February 23, 2015

Record last verified: 2015-02

Locations

CN (1)