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
|Condition or disease||Intervention/treatment||Phase|
|Hyperlipoproteinemia||Drug: Coenzyme A Drug: Pantethine||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
Pantethine 600mg per day.
- 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.
- 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.
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
|1st Affiliated Hospital, College of Medicine, Zhejiang University|
|Hangzhou, Zhejiang, China, 310003|
|Study Chair:||Junzhu Chen, MD||Zhejiang University|