DyslipidemiasPhase 4NCT01462877
A Study to Evaluate Fenofibrate Combination With Statin in Chinese Patients With Dyslipidemic
A Phase 4 study testing fenofibrate in people with Dyslipidemias and Cardiovascular Diseases, run by Abbott at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dyslipidemias, Cardiovascular Diseases, Hypertriglyceridemia
- What is being tested?
- fenofibrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 506 participants
- Where
- 1 siteChina
- Study dates
- Oct 2011to Mar 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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
- Conditions
- Dyslipidemias, Cardiovascular Diseases, Hypertriglyceridemia
- Being tested
- fenofibrate
- Keywords
- Lipid Regulating Agents, Drug Therapy, cardiovascular diseases, hypertriglyceridemia, Hydroxymethylglutaryl-CoA Reductase Inhibitors, fenofibrate, Dyslipidemias, Combination
- Medical subject headings
- Dyslipidemias, Cardiovascular Diseases, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fenofibrateDrug
Also called ABT-799, lipanthyl
Fenofibrate Capsule 200mg qd orally
| Study group | Role | What they receive |
|---|---|---|
| Fenofibrate arm | Other | Not described Receives: Drug: fenofibrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Triglyceride (TG) Change
Blood tests
Measured: Baseline and up to 8 weeks after intervention
Secondary outcomes (11)
Change in Serum Total Cholesterol
Blood tests
Measured: Baseline and up to 8 weeks after intervention
Change in Serum Low-density Lipoprotein Cholesterol
Blood tests
Measured: Baseline up to 8 weeks after intervention
Change in Serum High-density Lipoprotein Cholesterol
Blood tests
Measured: Baseline up to 8 weeks after intervention
Change in Serum Non-high-density Lipoprotein Cholesterol
Blood tests
Measured: Baseline up to 8 weeks after intervention
Change in Serum Apolipoprotein A1
Blood tests
Measured: Baseline up to 8 weeks after intervention
Change in Serum Apolipoprotein B
Blood tests
Measured: Baseline up to 8 weeks after intervention
Change in Serum Alanine Aminotransferase
Blood tests
Measured: Baseline up to 8 weeks after intervention
Change in Serum Aspartate Aminotransferase
Blood tests
Measured: Baseline up to 8 weeks after intervention
Change in Serum Creatine Kinase
Blood tests
Measured: Baseline up to 8 weeks after intervention
Change in Serum Creatinine
Blood tests
Measured: Baseline up to 8 weeks after intervention
Change in Serum High Sensitivity C-reactive Protein
Blood tests
Measured: Baseline and up to 8 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionFeb 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 506 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rundo International Pharmaceutical Research & Development Co.,Ltd.
- Responsible party
- Sponsor
- Investigators
- Lyra Xie, MD, Study chair, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01462877
- Sponsor's protocol ID
- W13-254
- Status last verified
- Feb 2015
- First submitted
- 28 Oct 2011
- Last updated
- 17 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center Study to Evaluate the Efficacy and Safety of Statin-fenofibrate Combination Therapy in Dyslipidemic Chinese Patients
- ClinicalTrials.gov ID
- NCT01462877
- Acronym / sponsor ID
- W13-254
- Conditions
- Dyslipidemias, Cardiovascular Diseases, Hypertriglyceridemia
- Keywords
- Lipid Regulating Agents, Drug Therapy, cardiovascular diseases, hypertriglyceridemia, Hydroxymethylglutaryl-CoA Reductase Inhibitors, fenofibrate, Dyslipidemias, Combination
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 506 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Collaborators
- Rundo International Pharmaceutical Research & Development Co.,Ltd.
- Study start
- Oct 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 1 Nov 2011 (estimated)
- Results
- Posted 23 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fenofibrate arm | Other | Drug: fenofibrate |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥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,
- ≥ 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fenofibrateAlso: ABT-799, lipanthylFenofibrate Capsule 200mg qd orally | Drug | Fenofibrate arm |
Primary outcome
Percentage of Triglyceride (TG) Change
Time frame: Baseline and up to 8 weeks after intervention
Blood tests
11 secondary outcomes
Change in Serum Total Cholesterol
Time frame: Baseline and up to 8 weeks after intervention
Change in Serum Low-density Lipoprotein Cholesterol
Time frame: Baseline up to 8 weeks after intervention
Change in Serum High-density Lipoprotein Cholesterol
Time frame: Baseline up to 8 weeks after intervention
Change in Serum Non-high-density Lipoprotein Cholesterol
Time frame: Baseline up to 8 weeks after intervention
Change in Serum Apolipoprotein A1
Time frame: Baseline up to 8 weeks after intervention
Change in Serum Apolipoprotein B
Time frame: Baseline up to 8 weeks after intervention
Change in Serum Alanine Aminotransferase
Time frame: Baseline up to 8 weeks after intervention
Change in Serum Aspartate Aminotransferase
Time frame: Baseline up to 8 weeks after intervention
Change in Serum Creatine Kinase
Time frame: Baseline up to 8 weeks after intervention
Change in Serum Creatinine
Time frame: Baseline up to 8 weeks after intervention
Change in Serum High Sensitivity C-reactive Protein
Time frame: Baseline and up to 8 weeks after intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lyra Xie, MD study chair
Abbott
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fenofibrate in people with Dyslipidemias and Cardiovascular Diseases, run by Abbott at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Triglyceride (TG) Change (time frame: Baseline and up to 8 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2015.