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

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ClinicalTrials.gov Identifier: NCT01811082
Recruitment Status : Completed
First Posted : March 14, 2013
Last Update Posted : March 15, 2013
Sponsor:
Information provided by (Responsible Party):
Jiangtao Lai, Zhejiang University

Brief 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.

Condition or disease Intervention/treatment Phase
Hyperlipoproteinemia Drug: Coenzyme A Drug: Pantethine Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : July 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : June 2011

Arm Intervention/treatment
Experimental: Coenzyme A 400mg
Coenzyme A 400mg per day
Drug: Coenzyme A
Coenzyme A 400mg per day.

Active Comparator: Pantethine 600mg
Pantethine 600mg per day.
Drug: Pantethine
Pantethine 600mg per day.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. serum total cholesterol, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol levels [ Time Frame: 10 months ]
    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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811082


Locations
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China, Zhejiang
1st Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003
Sponsors and Collaborators
Zhejiang University
Investigators
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Study Chair: Junzhu Chen, MD Zhejiang University

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Responsible Party: Jiangtao Lai, MD, Zhejiang University
ClinicalTrials.gov Identifier: NCT01811082     History of Changes
Other Study ID Numbers: 2010MMXX2CoA006
First Posted: March 14, 2013    Key Record Dates
Last Update Posted: March 15, 2013
Last Verified: March 2013
Additional relevant MeSH terms:
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Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases