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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Head-to-Head Comparison of Coenzyme A Capsule and Fenofibrate for Safety and Efficacy On Patients With Hyperlipidemia: A Phase III, Multicenter, Double-blinded, Double Dummy Clinical Trial.

Conditions
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Hyperlipoproteinemia

Intervention / Treatment
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* Drug: Coenzyme A
* Drug: Fenofibrate 200mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coenzyme A 400mg<br>Coenzyme A 400mg per day | Drug: Coenzyme A<br>* Coenzyme A 400mg per day<br>* Other names: Coenzyme A group;|
| Active Comparator: Fenofibrate 200mg<br>Fenofibrate 200mg per day | Drug: Fenofibrate 200mg<br>* Fenofibrate 200mg per day<br>* Other names: Fenofibrate group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum triglyceride level | The primary efficacy variable was the percentage change in serum lipid level from baseline to 4 and 8 weeks of treatment. | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum total cholesterol level | change from baseline to 4 and 8 weeks of treatment in serum total cholesterol level. | 10 months | 
| low-density lipoprotein cholesterol level | change from baseline to 4 and 8 weeks of treatment in serum low-density lipoprotein cholesterol level. | 10 months | 
| serum high-density lipoprotein cholesterol level | change from baseline to 4 and 8 weeks of treatment in serum high-density lipoprotein cholesterol level. | 10 months |