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

This study has been completed.
Sponsor:
Collaborator:
Rundo International Pharmaceutical Research & Development Co.,Ltd.
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01462877
First received: October 28, 2011
Last updated: April 9, 2014
Last verified: April 2014

October 28, 2011
April 9, 2014
October 2011
February 2014   (final data collection date for primary outcome measure)
Change in serum triglyceride [ Time Frame: Baseline, 4weeks and up to 8 weeks after intervention ] [ Designated as safety issue: No ]
Blood tests
Same as current
Complete list of historical versions of study NCT01462877 on ClinicalTrials.gov Archive Site
  • 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
  • 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: aseline, 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
Not Provided
Not Provided
 
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 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.

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

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Dyslipidemias
  • Cardiovascular Diseases
  • Hypertriglyceridemia
Drug: fenofibrate
Fenofibrate Capsule 200mg qd orally
Other Names:
  • ABT-799
  • fenofibrate
  • lipanthyl
Fenofibrate arm
Intervention: Drug: fenofibrate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
506
March 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01462877
W13-254
No
Abbott
Abbott
Rundo International Pharmaceutical Research & Development Co.,Ltd.
Study Chair: Lyra Xie, MD Abbott
Abbott
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP