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

Cardiovascular Diseases Clinical Trial

Official title:

An Open-label, Multi-center Study to Evaluate the Efficacy and Safety of Statin-fenofibrate Combination Therapy in Dyslipidemic Chinese Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01462877
• Other study ID #: W13-254
• Status: Completed
• Phase: Phase 4
• First received: October 28, 2011
• Last updated: February 25, 2015
• Start date: October 2011
• Est. completion date: March 2014

Study information

• Verified date: February 2015
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 506
• Est. completion date: March 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Dyslipidemias
• Hypertriglyceridemia

Intervention

Drug:
• fenofibrate
Fenofibrate Capsule 200mg qd orally

Locations

Country	Name	City	State
China	Site Reference ID/Investigator# 64695	Xiamen

Sponsors (2)

Lead Sponsor	Collaborator
Abbott	Rundo International Pharmaceutical Research & Development Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Triglyceride (TG) Change	Blood tests	Baseline and up to 8 weeks after intervention	No
Secondary	Change in Serum Total Cholesterol	Blood tests	Baseline and up to 8 weeks after intervention	No
Secondary	Change in Serum Low-density Lipoprotein Cholesterol	Blood tests	Baseline up to 8 weeks after intervention	No
Secondary	Change in Serum High-density Lipoprotein Cholesterol	Blood tests	Baseline up to 8 weeks after intervention	No
Secondary	Change in Serum Non-high-density Lipoprotein Cholesterol	Blood tests	Baseline up to 8 weeks after intervention	No
Secondary	Change in Serum Apolipoprotein A1	Blood tests	Baseline up to 8 weeks after intervention	No
Secondary	Change in Serum Apolipoprotein B	Blood tests	Baseline up to 8 weeks after intervention	No
Secondary	Change in Serum Alanine Aminotransferase	Blood tests	Baseline up to 8 weeks after intervention	Yes
Secondary	Change in Serum Aspartate Aminotransferase	Blood tests	Baseline up to 8 weeks after intervention	Yes
Secondary	Change in Serum Creatine Kinase	Blood tests	Baseline up to 8 weeks after intervention	Yes
Secondary	Change in Serum Creatinine	Blood tests	Baseline up to 8 weeks after intervention	Yes
Secondary	Change in Serum High Sensitivity C-reactive Protein	Blood tests	Baseline and up to 8 weeks after intervention	No