HyperlipoproteinemiaPhase 3NCT01811082
Comparison of Coenzyme A and Pantethine Capsule for Safety and Efficacy On Patients With Hyperlipidemia
A Phase 3 study testing Coenzyme A and Pantethine 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, Pantethine Capsule, 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 Pantethine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 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 meeting the China National Cholesterol Education Programme diagnostic criteria of hyperlipidemia;
- 18-75 years of age;
- women of childbearing potential not using pharmacological or mechanical contraception or with a negative pregnancy test.
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
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- 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 and HIV-infected 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.Patients using immunosuppressive drugs, prohibited medication or other lipid-lowing drugs were also excluded. Subjects were also ineligible for the study if they had any severe disease.
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 Pantethine Capsule 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, Pantethine Capsule, in Chinese patients with moderate dyslipidemia.
Read the detailed description
Hyperlipidemia plays important roles in the development and progression of atherosclerosis. Modulating lipid levels has been shown to reduce the development of atherosclerosis and incidence of cardiovascular disease. The HMG-CoA reductase inhibitors (also known as statins) are the most effective agents available in the management of hyperlipidemia and prevention of major cardiovascular events. Although statin based therapy is commonplace in primary and secondary prevention, several economical, clinical and safety issues have been raised, so that there is ongoing research into new, safer and more effective agents to be used alone or in combination with existing cardiovascular drugs.
Coenzyme A (CoA) is a ubiquitous essential cofactor that plays a central role in the metabolism of carboxylic acids, including short- and long-chain fatty acids, as well as carbohydrate and protein. In the metabolic pathway of lipid, CoA participates in fatty acid β-oxidation, promoting triglyceride (TG) catabolism. Previous research revealed that insufficiency of CoA in vivo influenced fatty acid β-oxidation catabolism and impaired clearance of TG from plasma, which was supposed to be one plausible reason resulting in type Ⅱb and Ⅳ hyperlipoproteinemia. In addition, epidemiological studies showed the prevalence of serum lipids level increased with age, which may be related to the reduction of CoA synthesis in aging individuals. Moreover, studies on animals have given evidence to prove that supplement of CoA had normalizing activity on plasma lipids in dyslipidemia.
Pantethine is a versatile and very well tolerated hypolipidemic agent that can decrease serum triglycerides, LDL cholesterol, and apolipoprotein B, while increasing HDL cholesterol and apolipoprotein A-I. Pantethine is the disulfide of pantetheine which per se occurs naturally as a product of coenzyme A catabolism. Theoretically, antihyperlipidemia effect of CoA should be more directly and effectively than pantethine. Researches on rabbits and rats models prove that high dose CoA orally can relieve fasting hyperlipidemia and insulin resistance induced by high fat diet. So far there has not been sufficient clinical research data to support the efficacy of CoA in dyslipidemia patients. The present study compares the safety and effectiveness of oral CoA and Pantetheine.
- Conditions
- Hyperlipoproteinemia
- Being tested
- Coenzyme A, Pantethine
- 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
Coenzyme A 400mg per day.
PantethineDrug
Pantethine 600mg per day.
| Study group | Role | What they receive |
|---|---|---|
| Coenzyme A 400mg | Experimental | Coenzyme A 400mg per day Receives: Drug: Coenzyme A |
| Pantethine 600mg | Active comparator | Pantethine 600mg per day. Receives: Drug: Pantethine |
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 (1)
serum total cholesterol, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol levels
The secondary endpoints were changes from baseline to 4 and 8 weeks of treatment in serum total cholesterol, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol levels.
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 Mar 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
- 240 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, MD, Study chair, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811082
- Sponsor's protocol ID
- 2010MMXX2CoA006
- Status last verified
- Mar 2013
- First submitted
- 10 Mar 2013
- Last updated
- 15 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 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 Pantethine Capsule for Safety and Efficacy On Patients With Hyperlipidemia: A Phase III, Multicenter, Double-blinded, Double Dummy Clinical Trial.
- ClinicalTrials.gov ID
- NCT01811082
- Acronym / sponsor ID
- 2010MMXX2CoA006
- Conditions
- Hyperlipoproteinemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 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 Mar 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, Pantethine Capsule, in Chinese patients with moderate dyslipidemia.
Detailed description
Hyperlipidemia plays important roles in the development and progression of atherosclerosis. Modulating lipid levels has been shown to reduce the development of atherosclerosis and incidence of cardiovascular disease. The HMG-CoA reductase inhibitors (also known as statins) are the most effective agents available in the management of hyperlipidemia and prevention of major cardiovascular events. Although statin based therapy is commonplace in primary and secondary prevention, several economical, clinical and safety issues have been raised, so that there is ongoing research into new, safer and more effective agents to be used alone or in combination with existing cardiovascular drugs.
Coenzyme A (CoA) is a ubiquitous essential cofactor that plays a central role in the metabolism of carboxylic acids, including short- and long-chain fatty acids, as well as carbohydrate and protein. In the metabolic pathway of lipid, CoA participates in fatty acid β-oxidation, promoting triglyceride (TG) catabolism. Previous research revealed that insufficiency of CoA in vivo influenced fatty acid β-oxidation catabolism and impaired clearance of TG from plasma, which was supposed to be one plausible reason resulting in type Ⅱb and Ⅳ hyperlipoproteinemia. In addition, epidemiological studies showed the prevalence of serum lipids level increased with age, which may be related to the reduction of CoA synthesis in aging individuals. Moreover, studies on animals have given evidence to prove that supplement of CoA had normalizing activity on plasma lipids in dyslipidemia.
Pantethine is a versatile and very well tolerated hypolipidemic agent that can decrease serum triglycerides, LDL cholesterol, and apolipoprotein B, while increasing HDL cholesterol and apolipoprotein A-I. Pantethine is the disulfide of pantetheine which per se occurs naturally as a product of coenzyme A catabolism. Theoretically, antihyperlipidemia effect of CoA should be more directly and effectively than pantethine. Researches on rabbits and rats models prove that high dose CoA orally can relieve fasting hyperlipidemia and insulin resistance induced by high fat diet. So far there has not been sufficient clinical research data to support the efficacy of CoA in dyslipidemia patients. The present study compares the safety and effectiveness of oral CoA and Pantetheine.
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 |
| Pantethine 600mg | Active comparator | Drug: PantethinePantethine 600mg per day. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- TG 2.3～6.5mmol/l meeting the China National Cholesterol Education Programme diagnostic criteria of hyperlipidemia;
- 18-75 years of age;
- women of childbearing potential not using pharmacological or mechanical contraception or with a negative pregnancy test.
Key exclusion criteria (11 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 ACoenzyme A 400mg per day. | Drug | Coenzyme A 400mg |
| PantethinePantethine 600mg per day. | Drug | Pantethine 600mg |
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.
1 secondary outcome
serum total cholesterol, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol levels
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 15 Mar 2013.
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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, MD 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 Pantethine 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 3 inclusion and 11 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 15 Mar 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 15 Mar 2013.