- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01878227
Comparison of Coenzyme A and Fenofibrate for Safety and Efficacy On Patients With Hyperlipidemia
June 11, 2013 updated by: Jiangtao Lai, Zhejiang University
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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
420
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310003
- 1st Affiliated Hospital, College of Medicine, Zhejiang University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Coenzyme A 400mg
Coenzyme A 400mg per day
|
Coenzyme A 400mg per day
Other Names:
|
Active Comparator: Fenofibrate 200mg
Fenofibrate 200mg per day
|
Fenofibrate 200mg per day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
serum triglyceride level
Time Frame: 10 months
|
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
Time Frame: 10 months
|
change from baseline to 4 and 8 weeks of treatment in serum total cholesterol level.
|
10 months
|
low-density lipoprotein cholesterol level
Time Frame: 10 months
|
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
Time Frame: 10 months
|
change from baseline to 4 and 8 weeks of treatment in serum high-density lipoprotein cholesterol level.
|
10 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (Actual)
May 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
June 10, 2013
First Submitted That Met QC Criteria
June 11, 2013
First Posted (Estimate)
June 14, 2013
Study Record Updates
Last Update Posted (Estimate)
June 14, 2013
Last Update Submitted That Met QC Criteria
June 11, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010MMXX2CoA007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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