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

Hyperlipoproteinemia Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01878227
• Other study ID #: 2010MMXX2CoA007
• Status: Completed
• Phase: Phase 3
• First received: June 10, 2013
• Last updated: June 11, 2013
• Start date: July 2010
• Est. completion date: June 2011

Study information

• Verified date: June 2013
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipidemias
• Hyperlipoproteinemia
• Hyperlipoproteinemias

Intervention

Drug:
• Coenzyme A
Coenzyme A 400mg per day
• Fenofibrate 200mg
Fenofibrate 200mg per day

Locations

Country	Name	City	State
China	1st Affiliated Hospital, College of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	serum total cholesterol level	change from baseline to 4 and 8 weeks of treatment in serum total cholesterol level.	10 months	Yes
Secondary	low-density lipoprotein cholesterol level	change from baseline to 4 and 8 weeks of treatment in serum low-density lipoprotein cholesterol level.	10 months	Yes
Secondary	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	Yes