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

This study is currently recruiting participants.
Verified February 2013 by Abbott
Sponsor:
Collaborator:
RUNDO International Pharmaceuticals Research & Development Co., Ltd
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01462877
First received: October 28, 2011
Last updated: February 20, 2013
Last verified: February 2013
History of Changes
  Purpose

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 recent published 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.


Condition Intervention Phase
Dyslipidemias
Cardiovascular Diseases
Hypertriglyceridemia
 Drug: fenofibrate
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Multi-center Study to Evaluate the Efficacy and Safety of Statin-fenofibrate Combination Therapy in Dyslipidemic Chinese Patients

Resource links provided by NLM:

Drug Information available for: Fenofibrate
U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Change in serum triglyceride [ Time Frame: Baseline, 4weeks and up to 8 weeks after intervention ] [ Designated as safety issue: No ]
    Blood tests


Secondary Outcome Measures:
  • Change in serum total cholesterol [ Time Frame: Baseline, 4weeks and up to 8 weeks after intervention ] [ Designated as safety issue: No ]
    Blood tests

  • Change in serum low-density lipoprotein cholesterol [ Time Frame: Baseline, 4weeks and up to 8 weeks after intervention ] [ Designated as safety issue: No ]
    Blood tests

  • Change in serum high-density lipoprotein cholesterol [ Time Frame: Baseline, 4weeks and up to 8 weeks after intervention ] [ Designated as safety issue: No ]
    Blood tests

  • Change in serum non-high-density lipoprotein cholesterol [ Time Frame: Baseline, 4weeks and up to 8 weeks after intervention ] [ Designated as safety issue: No ]
    Blood tests

  • Change in serum apolipoprotein A1 [ Time Frame: Baseline, 4weeks and up to 8 weeks after intervention ] [ Designated as safety issue: No ]
    Blood tests

  • Change in serum apolipoprotein B [ Time Frame: Baseline, 4weeks and up to 8 weeks after intervention ] [ Designated as safety issue: No ]
    Blood tests

  • Change in serum alanine aminotransferase [ Time Frame: Baseline, 4weeks and up to 8 weeks after intervention ] [ Designated as safety issue: Yes ]
    Blood tests

  • Change in serum aspartate aminotransferase [ Time Frame: Baseline, 4weeks and up to 8 weeks after intervention ] [ Designated as safety issue: Yes ]
    Blood tests

  • Change in serum creatine kinase [ Time Frame: Baseline, 4weeks and up to 8 weeks after intervention ] [ Designated as safety issue: Yes ]
    Blood tests

  • Change in blood urea nitrogen [ Time Frame: Baseline, 4weeks and up to 8 weeks after intervention ] [ Designated as safety issue: Yes ]
    Blood tests

  • Change in serum Creatinine [ Time Frame: Baseline, 4weeks and up to 8 weeks after intervention ] [ Designated as safety issue: Yes ]
    Blood tests

  • Change in serum high sensitivity C-reactive protein [ Time Frame: Baseline and up to 8 weeks after intervention ] [ Designated as safety issue: No ]
    Blood tests


Estimated Enrollment: 720
Study Start Date: October 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Fenofibrate arm Drug: fenofibrate
Fenofibrate Capsule 200mg qd orally
Other Names:
  • ABT-799
  • fenofibrate
  • lipanthyl

Detailed Description:

It is an open-label , single group, multi-center study. At around 30 investigate site, 720 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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01462877

Contacts
Contact: Bing Liu, MD 86-021-23204476 bing.liu@abbott.com
Contact: Steven Yu, MD 86-021-23204579 steven.yu@abbott.com

Locations
China
Site Reference ID/Investigator# 64695 Recruiting
Xiamen, China, 36100
Principal Investigator: Site Reference ID/Investigator# 64695            
Sponsors and Collaborators
Abbott
RUNDO International Pharmaceuticals Research & Development Co., Ltd
Investigators
Study Chair: Lyra Xie, MD Abbott
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01462877     History of Changes
Other Study ID Numbers: W13-254
Study First Received: October 28, 2011
Last Updated: February 20, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Abbott:
Lipid Regulating Agents
Drug Therapy
cardiovascular diseases
hypertriglyceridemia
 Hydroxymethylglutaryl-CoA Reductase Inhibitors
fenofibrate
Dyslipidemias
Combination

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypertriglyceridemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Fenofibrate
Lipid Regulating Agents
 Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013