The Effects of Coenzyme A Combined With Statin on Serum Lipids in Patients With Hyperlipidemia
1 other identifier
interventional
320
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 16, 2013
CompletedFirst Posted
Study publicly available on registry
August 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedAugust 23, 2013
August 1, 2013
1.5 years
August 16, 2013
August 19, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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 (3)
serum total cholesterol level
8 weeks
low-density lipoprotein cholesterol level
8 weeks
serum high-density lipoprotein cholesterol level
8 weeks
Study Arms (2)
Coenzyme A 400mg
EXPERIMENTALCoenzyme A 400mg per day
Placebo
PLACEBO COMPARATORCapsule without coenzyme A.
Interventions
Eligibility Criteria
You may qualify if:
- TG 2.3～7.0mmol/l
- years of age
- combined use with statins
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
1st Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003, China
Related Publications (1)
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.
PMID: 24382338DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Junzhu Chen
Zhejiang University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
August 16, 2013
First Posted
August 23, 2013
Study Start
March 1, 2012
Primary Completion
September 1, 2013
Study Completion
October 1, 2013
Last Updated
August 23, 2013
Record last verified: 2013-08