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The Effects of Coenzyme A Combined With Statin on Serum Lipids in Patients With Hyperlipidemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01928342
Recruitment Status : Unknown
Verified August 2013 by Jiangtao Lai, Zhejiang University.
Recruitment status was:  Recruiting
First Posted : August 23, 2013
Last Update Posted : August 23, 2013
Sponsor:
Information provided by (Responsible Party):
Jiangtao Lai, Zhejiang University

Brief Summary:
The purpose of this study is to evaluate the lipid lowering effects and clinical safety of a natural hypolipidemic compound, coenzyme A (CoA) capsule, combined use with statin, in Chinese patients with moderate dyslipidemia.

Condition or disease Intervention/treatment Phase
Hyperlipoproteinemia Drug: Coenzyme A Drug: Placebo Phase 2 Phase 3

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 combined with statin in dyslipidemia patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Coenzyme A Combined With Statin on Serum Lipids in Patients With Hyperlipidemia: a Randomized, Double-blinded, Placebo-controlled, Multi-center Clinical Trial
Study Start Date : March 2012
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : October 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Coenzyme A 400mg
Coenzyme A 400mg per day
Drug: Coenzyme A
Coenzyme A 400mg per day
Other Name: Coenzyme A group

Placebo Comparator: Placebo
Capsule without coenzyme A.
Drug: Placebo
Capsule without coenzyme A.
Other Name: Controls.




Primary Outcome Measures :
  1. serum triglyceride level [ Time Frame: 8 weeks ]
    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 level [ Time Frame: 8 weeks ]
    change from baseline to 4 and 8 weeks of treatment in serum total cholesterol level

  2. low-density lipoprotein cholesterol level [ Time Frame: 8 weeks ]
    change from baseline to 4 and 8 weeks of treatment in serum low-density lipoprotein cholesterol level.

  3. serum high-density lipoprotein cholesterol level [ Time Frame: 8 weeks ]
    change from baseline to 4 and 8 weeks of treatment in serum high-density lipoprotein cholesterol level.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • TG 2.3~7.0mmol/l
  • 18-80 years of age
  • combined use with statins

Exclusion Criteria:

  • pregnancy
  • acute liver disease or hepatic dysfunction, as determined by levels of alanine aminotransferase (ALT) or aspartate aminotransferase levels (AST) more than 2-fold the upper normal limit
  • nephrotic syndrome or serum creatinine (Cr) ≥2-fold the upper normal limit 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
  • using contraceptive agent
  • using immunosuppressive drugs, prohibited medication or other non-statin lipid-lowing drugs

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): NCT01928342


Contacts
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Contact: Jiangtao Lai, MD 8657187236502

Locations
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China, Zhejiang
1st Affiliated Hospital, College of Medicine, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310003
Contact: Jiangtao Lai, MD    8657187236502      
Principal Investigator: Junzhu Chen, MD         
Sponsors and Collaborators
Zhejiang University
Investigators
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Study Chair: Junzhu Chen Zhejiang University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jiangtao Lai, MD, Zhejiang University
ClinicalTrials.gov Identifier: NCT01928342    
Other Study ID Numbers: 2012MMXX2CoA008
First Posted: August 23, 2013    Key Record Dates
Last Update Posted: August 23, 2013
Last Verified: August 2013
Additional relevant MeSH terms:
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Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases