HyperlipoproteinemiaPhase 3NCT01878227
Comparison of Coenzyme A and Fenofibrate for Safety and Efficacy On Patients With Hyperlipidemia
A Phase 3 study testing Coenzyme A and Fenofibrate 200mg in people with Hyperlipoproteinemia, run by Zhejiang University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hyperlipoproteinemia
- What is being tested?
- Coenzyme A and Fenofibrate 200mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteChina
- Study dates
- Jul 2010to Jun 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- TG 2.3～6.5mmol/l
- 18-75 years of age
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
1st Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
About this study
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.
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.
Read the 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
- Being tested
- Coenzyme A, Fenofibrate 200mg
- Medical subject headings
- Hyperlipoproteinemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme ADrug
Also called Coenzyme A group
Coenzyme A 400mg per day
Fenofibrate 200mgDrug
Also called Fenofibrate group
Fenofibrate 200mg per day
| Study group | Role | What they receive |
|---|---|---|
| Coenzyme A 400mg | Experimental | Coenzyme A 400mg per day Receives: Drug: Coenzyme A |
| Fenofibrate 200mg | Active comparator | Fenofibrate 200mg per day Receives: Drug: Fenofibrate 200mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum triglyceride level
The primary efficacy variable was the percentage change in serum lipid level from baseline to 4 and 8 weeks of treatment.
Measured: 10 months
Secondary outcomes (3)
serum total cholesterol level
change from baseline to 4 and 8 weeks of treatment in serum total cholesterol level.
Measured: 10 months
low-density lipoprotein cholesterol level
change from baseline to 4 and 8 weeks of treatment in serum low-density lipoprotein cholesterol level.
Measured: 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.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2013 (estimated)
- Study startJul 2010
- Primary completionMay 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipoproteinemiaStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiangtao Lai, Zhejiang University
- Investigators
- Junzhu Chen, Study chair, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01878227
- Sponsor's protocol ID
- 2010MMXX2CoA007
- Status last verified
- Jun 2013
- First submitted
- 10 Jun 2013
- Last updated
- 14 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01878227
- Acronym / sponsor ID
- 2010MMXX2CoA007
- Conditions
- Hyperlipoproteinemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 14 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coenzyme A 400mg | Experimental | Drug: Coenzyme ACoenzyme A 400mg per day |
| Fenofibrate 200mg | Active comparator | Drug: Fenofibrate 200mgFenofibrate 200mg per day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- TG 2.3～6.5mmol/l
- 18-75 years of age
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coenzyme AAlso: Coenzyme A groupCoenzyme A 400mg per day | Drug | Coenzyme A 400mg |
| Fenofibrate 200mgAlso: Fenofibrate groupFenofibrate 200mg per day | Drug | Fenofibrate 200mg |
Primary outcome
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.
3 secondary outcomes
serum total cholesterol level
Time frame: 10 months
low-density lipoprotein cholesterol level
Time frame: 10 months
serum high-density lipoprotein cholesterol level
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2013.
Related trials for Hyperlipoproteinemia
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Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junzhu Chen study chair
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Coenzyme A and Fenofibrate 200mg in people with Hyperlipoproteinemia, run by Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum triglyceride level (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2013.