The Effects of Coenzyme A Combined With Statin on Serum L... | NCT01928342

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

NCT01928342

Sponsor

Zhejiang University

Status

Unknown status

Last Update Posted

Aug 23, 2013Estimated

Enrollment

320Estimated

Phase

Phase 2Phase 3

Conditions

Hyperlipoproteinemia

Interventions

Coenzyme A
Placebo

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Sep 2013Estimated

Completion Date

Oct 2013Estimated

First Submitted Date

Aug 16, 2013

First Submission Date that Met QC Criteria

Aug 19, 2013

First Posted Date

Aug 23, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2013

Last Update Posted Date

Aug 23, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

320Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Coenzyme A 400mg	Experimental	Coenzyme A 400mg per day	Drug: Coenzyme A
Placebo	Placebo Comparator	Capsule without coenzyme A.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Coenzyme A	Drug	Coenzyme A 400mg per day	Coenzyme A 400mg	Coenzyme A group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
serum triglyceride level	The primary efficacy variable was the percentage change in serum lipid level from baseline to 4 and 8 weeks of treatment.	8 weeks

Secondary Outcomes

Measure	Description	Time Frame
serum total cholesterol level	change from baseline to 4 and 8 weeks of treatment in serum total cholesterol level	8 weeks
low-density lipoprotein cholesterol level	change from baseline to 4 and 8 weeks of treatment in serum low-density lipoprotein cholesterol level.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jiangtao Lai, MD	Contact	8657187236502

Overall Officials

Name	Affiliation	Role
Junzhu Chen	Zhejiang University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
1st Affiliated Hospital, College of Medicine, Zhejiang University	Recruiting	Hangzhou	Zhejiang	310003	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24382338	Derived	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.

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases

ID	Term
D000227	Adenine Nucleotides
D011685	Purine Nucleotides
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring