NCT01462877

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 506 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	fenofibrate	Fenofibrate Capsule 200mg qd orally

Timeline

• Start date: 2011-10-01
• Primary completion: 2014-02-01
• Completion: 2014-03-01
• First posted: 2011-11-01
• Last updated: 2015-03-17
• Results posted: 2015-02-23

Locations

1 site across 1 country: China