Comparison of Coenzyme A and Fenofibrate for Safety and Efficacy On Patients With Hyperlipidemia

NCT ID: NCT01878227

Last Updated: 2013-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2011-06-30

Brief Summary

The purpose of this study is to compare the lipid lowering effects and clinical safety of a natural hypolipidemic compound, coenzyme A capsule with a marketed drug, fenofibrate, in Chinese patients with moderate dyslipidemia.

Detailed Description

Although lowering cholesterol and low-density lipoprotein-cholesterol (LDL-C) is the mainstay of medical therapy for cardiovascular event prevention, evidence from clinical trials supports a role for elevated triglyceride (TG) and low high-density lipoprotein cholesterol (HDL-C) concentrations in the residual cardiovascular risk on statin treatment. Fenofibrate is the most commonly used agent to control hypertriglyceridemia as monotherapy or combining with statin, which lowers TG and raises HDL-C through multifaceted mechanism by PPARα activation. However, safety of coadministration of statin with fenofibrate has been a great concern, especially drug-induced hepatotoxicity when they are combined used. Coenzyme A (CoA) functions as an acyl group carrier and assists in transferring fatty acids from the cytoplasm to mitochondria. It is also involved in the oxidation and catabolism of fatty acids. Animal studies have proved its lipid-lowering effects. In a previous multicenter study we conducted in 2008, it was found that oral CoA 400U/d effectively lowered serum TG levels in hypertriglyceridemia patients without increasing adverse effects when compared with placebo. So, the present study was performed to further investigate the lipid-lowing effects and safety of CoA capsule by comparing with fenofibrate.

Conditions

Hyperlipoproteinemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Coenzyme A 400mg

Coenzyme A 400mg per day

Group Type: EXPERIMENTAL

Coenzyme A

Intervention Type: DRUG

Coenzyme A 400mg per day

Fenofibrate 200mg

Fenofibrate 200mg per day

Group Type: ACTIVE_COMPARATOR

Fenofibrate 200mg

Intervention Type: DRUG

Fenofibrate 200mg per day

Interventions

Coenzyme A

Coenzyme A 400mg per day

Intervention Type: DRUG

Fenofibrate 200mg

Fenofibrate 200mg per day

Intervention Type: DRUG

Other Intervention Names

Coenzyme A group; Fenofibrate group

Eligibility Criteria

Inclusion Criteria

• TG 2.3～6.5mmol/l
• 18-75 years of age

Exclusion Criteria

• TC >7.0 mmol/l;
• Body Mass Index > 30 kg/m2
• drug induced secondary hypercholesterolemia (such as dibenzothiazine, contraceptive agent or adrenal cortex hormone)
• pregnancy
• acute coronary syndrome, acute myocardial infarction or undergone a revascularization procedure within 6 months
• acute liver disease or hepatic dysfunction, as determined by levels of alanine aminotransferase (ALT) or aspartate aminotransferase levels (AST) more than 3-fold the upper normal limit
• nephrotic syndrome or serum creatinine (Cr) (≥179 µmol/L) and creatine •phosphokinase (CK) more than 3-fold the upper normal limit
• primary hypothyroidism
• psychiatric patients
• poorly controlled hypertension, as indicated by a Systolic Blood Pressure >180 mmHg or Diastolic Blood Pressure >110 mmHg
• Type I diabetes mellitus（DM）, poorly controlled Type II DM (BS>11.0 mmol/L ) or Type II DM with LDL-C >2.6 mmol/L.
• using immunosuppressive drugs, prohibited medication or other lipid-lowing drugs

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Jiangtao Lai

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Junzhu Chen

Role: STUDY_CHAIR

Zhejiang University

Locations

1st Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

2010MMXX2CoA007

Identifier Type: -

Identifier Source: org_study_id