Comparison of Coenzyme A and Fenofibrate for Safety and Efficacy On Patients With Hyperlipidemia
Randomized Head-to-Head Comparison of Coenzyme A Capsule and Fenofibrate for Safety and Efficacy On Patients With Hyperlipidemia: A Phase III, Multicenter, Double-blinded, Double Dummy Clinical Trial.
1 other identifier
interventional
420
1 country
1
Brief Summary
The purpose of this study is to compare the lipid lowering effects and clinical safety of a natural hypolipidemic compound, coenzyme A capsule with a marketed drug, fenofibrate, 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 P50-P75 for phase_3
Started Jul 2010
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 10, 2013
CompletedFirst Posted
Study publicly available on registry
June 14, 2013
CompletedJune 14, 2013
June 1, 2013
10 months
June 10, 2013
June 11, 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.
10 months
Secondary Outcomes (3)
serum total cholesterol level
10 months
low-density lipoprotein cholesterol level
10 months
serum high-density lipoprotein cholesterol level
10 months
Study Arms (2)
Coenzyme A 400mg
EXPERIMENTALCoenzyme A 400mg per day
Fenofibrate 200mg
ACTIVE COMPARATORFenofibrate 200mg per day
Interventions
Eligibility Criteria
You may qualify if:
- TG 2.3～6.5mmol/l
- years of age
You may not qualify if:
- TC \>7.0 mmol/l;
- Body Mass Index \> 30 kg/m2
- drug induced secondary hypercholesterolemia (such as dibenzothiazine, contraceptive agent or adrenal cortex hormone)
- pregnancy
- acute coronary syndrome, acute myocardial infarction or undergone a revascularization procedure within 6 months
- acute liver disease or hepatic dysfunction, as determined by levels of alanine aminotransferase (ALT) or aspartate aminotransferase levels (AST) more than 3-fold the upper normal limit
- nephrotic syndrome or serum creatinine (Cr) (≥179 µmol/L) 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
- Type I diabetes mellitus（DM）, poorly controlled Type II DM (BS\>11.0 mmol/L ) or Type II DM with LDL-C \>2.6 mmol/L.
- using immunosuppressive drugs, prohibited medication or other 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Junzhu Chen
Zhejiang University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- 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
June 10, 2013
First Posted
June 14, 2013
Study Start
July 1, 2010
Primary Completion
May 1, 2011
Study Completion
June 1, 2011
Last Updated
June 14, 2013
Record last verified: 2013-06