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

NCT ID: NCT01928342

Last Updated: 2013-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hyperlipoproteinemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Coenzyme A 400mg

Coenzyme A 400mg per day

Group Type EXPERIMENTAL

Coenzyme A

Intervention Type DRUG

Coenzyme A 400mg per day

Placebo

Capsule without coenzyme A.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Capsule without coenzyme A.

Interventions

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Coenzyme A

Coenzyme A 400mg per day

Intervention Type DRUG

Placebo

Capsule without coenzyme A.

Intervention Type DRUG

Other Intervention Names

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Coenzyme A group Controls.

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Jiangtao Lai

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Junzhu Chen

Role: STUDY_CHAIR

Zhejiang University

Locations

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1st Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jiangtao Lai, MD

Role: CONTACT

Phone: 8657187236502

Facility Contacts

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Jiangtao Lai, MD

Role: primary

References

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Lai J, Wu B, Xuan T, Liu Z, Chen J. Efficacy and tolerability of adding coenzyme A 400 U/d capsule to stable statin therapy for the treatment of patients with mixed dyslipidemia: an 8-week, multicenter, double-blind, randomized, placebo-controlled study. Lipids Health Dis. 2014 Jan 2;13:1. doi: 10.1186/1476-511X-13-1.

Reference Type DERIVED
PMID: 24382338 (View on PubMed)

Other Identifiers

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2012MMXX2CoA008

Identifier Type: -

Identifier Source: org_study_id