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CompletedNCT01462877Updated Mar 17, 2015Results posted

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

A Phase 4 interventional study of fenofibrate in Dyslipidemias, Cardiovascular Diseases and Hypertriglyceridemia, sponsored by Abbott. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-03-17.

Sponsored by Abbott · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
506
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Dyslipidemias
  • Cardiovascular Diseases
  • Hypertriglyceridemia

Keywords

  • Lipid Regulating Agents
  • Drug Therapy
  • cardiovascular diseases
  • hypertriglyceridemia
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • fenofibrate
  • Dyslipidemias
  • Combination
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 920 are open to participants now.

This study's enrollment of 506 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Abbott is the lead sponsor of 350 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
506 participants (actual)

Study arms

  • Other
    Fenofibrate arm

    Drug: fenofibrate

Interventions

  • Drugfenofibrate

    Fenofibrate Capsule 200mg qd orally

    Also known as: ABT-799, lipanthyl

06

What researchers measure

Primary outcomes

  1. Percentage of Triglyceride (TG) Change

    Blood tests

    Time frame: Baseline and up to 8 weeks after intervention

Secondary outcomes

  1. Change in Serum Total Cholesterol

    Blood tests

    Time frame: Baseline and up to 8 weeks after intervention

  2. Change in Serum Low-density Lipoprotein Cholesterol

    Blood tests

    Time frame: Baseline up to 8 weeks after intervention

  3. Change in Serum High-density Lipoprotein Cholesterol

    Blood tests

    Time frame: Baseline up to 8 weeks after intervention

  4. Change in Serum Non-high-density Lipoprotein Cholesterol

    Blood tests

    Time frame: Baseline up to 8 weeks after intervention

  5. Change in Serum Apolipoprotein A1

    Blood tests

    Time frame: Baseline up to 8 weeks after intervention

  6. Change in Serum Apolipoprotein B

    Blood tests

    Time frame: Baseline up to 8 weeks after intervention

  7. Change in Serum Alanine Aminotransferase

    Blood tests

    Time frame: Baseline up to 8 weeks after intervention

  8. Change in Serum Aspartate Aminotransferase

    Blood tests

    Time frame: Baseline up to 8 weeks after intervention

  9. Change in Serum Creatine Kinase

    Blood tests

    Time frame: Baseline up to 8 weeks after intervention

  10. Change in Serum Creatinine

    Blood tests

    Time frame: Baseline up to 8 weeks after intervention

  11. Change in Serum High Sensitivity C-reactive Protein

    Blood tests

    Time frame: Baseline and up to 8 weeks after intervention

07

Results

Posted Feb 23, 2015

Participant flow

Dyslipidemic Chinese patients with CHD or CHD equivalent, whose TG ≥1.70 mmol/L and \<5.65mmol/L after at least 2 month statin monotherapy with standard dose were enrolled. After at least 2 month statin monotherapy with standard dose, patients having high TG were recruited and given statin-fenofibrate combination therapy for 8 weeks.

Participant flow — Overall Study
MilestoneFenofibrate Arm
Started506
Safety set492
Full analysis set468
Per-protocol set364
Completed435
Not completed71

Outcome measures

PrimaryPercentage of Triglyceride (TG) Change

Blood tests

Time frame:
Baseline and up to 8 weeks after intervention
Reported as:
Mean · percentage of TG change
Percentage of Triglyceride (TG) Change
percentage of TG changeFenofibrate Arm
Percentage of Triglyceride (TG) Change-38.12 ± 33.92
SecondaryChange in Serum Total Cholesterol

Blood tests

Time frame:
Baseline and up to 8 weeks after intervention
Reported as:
Mean · percentage of TC change
Change in Serum Total Cholesterol
percentage of TC changeFenofibrate Arm
Change in Serum Total Cholesterol2.75 ± 24.75
SecondaryChange in Serum Low-density Lipoprotein Cholesterol

Blood tests

Time frame:
Baseline up to 8 weeks after intervention
Reported as:
Mean · percentage of LDL-C change
Change in Serum Low-density Lipoprotein Cholesterol
percentage of LDL-C changeFenofibrate Arm
Change in Serum Low-density Lipoprotein Cholesterol14.91 ± 39.80
SecondaryChange in Serum High-density Lipoprotein Cholesterol

Blood tests

Time frame:
Baseline up to 8 weeks after intervention
Reported as:
Mean · percentage of HDL-C change
Change in Serum High-density Lipoprotein Cholesterol
percentage of HDL-C changeFenofibrate Arm
Change in Serum High-density Lipoprotein Cholesterol17.40 ± 32.62
SecondaryChange in Serum Non-high-density Lipoprotein Cholesterol

Blood tests

Time frame:
Baseline up to 8 weeks after intervention
Reported as:
Mean · percentage of Non-HDL-C change
Change in Serum Non-high-density Lipoprotein Cholesterol
percentage of Non-HDL-C changeFenofibrate Arm
Change in Serum Non-high-density Lipoprotein Cholesterol-1.30 ± 28.26
SecondaryChange in Serum Apolipoprotein A1

Blood tests

Time frame:
Baseline up to 8 weeks after intervention
Reported as:
Mean · percentage of apoA1 change
Change in Serum Apolipoprotein A1
percentage of apoA1 changeFenofibrate Arm
Change in Serum Apolipoprotein A112.41 ± 28.74
SecondaryChange in Serum Apolipoprotein B

Blood tests

Time frame:
Baseline up to 8 weeks after intervention
Reported as:
Mean · percentage of apoB change
Change in Serum Apolipoprotein B
percentage of apoB changeFenofibrate Arm
Change in Serum Apolipoprotein B2.42 ± 50.48
SecondaryChange in Serum Alanine Aminotransferase

Blood tests

Time frame:
Baseline up to 8 weeks after intervention
Reported as:
Median · percentage of ALT change
Change in Serum Alanine Aminotransferase
percentage of ALT changeFenofibrate Arm
Change in Serum Alanine Aminotransferase0.00 (-72.92 to 1118.75)
SecondaryChange in Serum Aspartate Aminotransferase

Blood tests

Time frame:
Baseline up to 8 weeks after intervention
Reported as:
Median · percentage of AST change
Change in Serum Aspartate Aminotransferase
percentage of AST changeFenofibrate Arm
Change in Serum Aspartate Aminotransferase10.91 (-77.73 to 676.47)
SecondaryChange in Serum Creatine Kinase

Blood tests

Time frame:
Baseline up to 8 weeks after intervention
Reported as:
Median · percentage of CK change
Change in Serum Creatine Kinase
percentage of CK changeFenofibrate Arm
Change in Serum Creatine Kinase8.02 (-73.94 to 1429.63)
SecondaryChange in Serum Creatinine

Blood tests

Time frame:
Baseline up to 8 weeks after intervention
Reported as:
Median · percentage of Creatinine change
Change in Serum Creatinine
percentage of Creatinine changeFenofibrate Arm
Change in Serum Creatinine12.99 (-63.63 to 80.43)
SecondaryChange in Serum High Sensitivity C-reactive Protein

Blood tests

Time frame:
Baseline and up to 8 weeks after intervention

Results for this outcome have not been posted.

Adverse events

Collected over 8 weeks + 1 month. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Fenofibrate Arm—7/492 (1.4%)23/492 (4.7%)
Most frequent serious events
Most frequent serious events
EventFenofibrate Arm
Hepatic enzyme increasedHepatobiliary disorders1/492
Angina unstableCardiac disorders1/492
Myocardial infarctionCardiac disorders1/492
Coronary artery diseaseCardiac disorders1/492
Pulmonary embolismRespiratory, thoracic and mediastinal disorders1/492
Herpes zosterInfections and infestations1/492
Intervertebral disc protrusionMusculoskeletal and connective tissue disorders1/492
Most frequent other events
Most frequent other events
EventFenofibrate Arm
Alanine aminotransferase increasedInvestigations6/492
Aspartate aminotransferase increasedInvestigations6/492
Blood creatine phosphokinase increasedInvestigations6/492
NauseaGastrointestinal disorders5/492

Baseline characteristics

Full Analysis Set

Age, Continuous
Age, Continuous(years)Fenofibrate Arm
Mean58 ± 9.91
Sex: Female, Male
Sex: Female, Male(Participants)Fenofibrate Arm
Female194
Male274
Systolic blood pressure
Systolic blood pressure(mmHg)Fenofibrate Arm
Mean130.93 ± 12.50
diastolic blood pressure
diastolic blood pressure(mmHg)Fenofibrate Arm
Mean78.54 ± 8.97
08

Study locations

1 site
  • Site Reference ID/Investigator# 64695
    Xiamen, 36100, China
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01462877
Lead sponsor
Abbott
Collaborators
Rundo International Pharmaceutical Research & Development Co.,Ltd.
Responsible party
Sponsor
First posted
Nov 1, 2011
Start date
Oct 2011
Primary completion
Feb 2014
Completion
Mar 2014
Results posted
Feb 23, 2015
Last update
Mar 17, 2015

Study contacts

Lyra Xie, MD
study chair · Abbott

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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