Status:
COMPLETED
Comparison of Coenzyme A and Pantethine Capsule for Safety and Efficacy On Patients With Hyperlipidemia
Lead Sponsor:
Zhejiang University
Conditions:
Hyperlipoproteinemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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, Pantethine Capsule, in Chinese pati...
Detailed Description
Hyperlipidemia plays important roles in the development and progression of atherosclerosis. Modulating lipid levels has been shown to reduce the development of atherosclerosis and incidence of cardiov...
Eligibility Criteria
Inclusion
- TG 2.3～6.5mmol/l meeting the China National Cholesterol Education Programme diagnostic criteria of hyperlipidemia;
- 18-75 years of age;
- women of childbearing potential not using pharmacological or mechanical contraception or with a negative pregnancy test.
Exclusion
- 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 and HIV-infected 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.Patients using immunosuppressive drugs, prohibited medication or other lipid-lowing drugs were also excluded. Subjects were also ineligible for the study if they had any severe disease.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT01811082
Start Date
July 1 2010
End Date
June 1 2011
Last Update
March 15 2013
Active Locations (1)
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1
1st Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003