Overview

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

Status:
Completed
Trial end date:
2009-08-01
Target enrollment:
0
Participant gender:
All
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 in Chinese patients with moderate dyslipidemia.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Zhejiang University
Criteria
Inclusion Criteria:

- TG 2.3~6.5mmol/l meeting the China National Cholesterol Education Programme diagnostic
criteria of hyperlipidemia.

Exclusion Criteria:

1. TC >7.5 mmol/l or LDL-C >3.6 mmol/l

2. Body Mass Index > 30 kg/m2

3. drug induced secondary hypercholesterolemia (such as dibenzothiazine, contraceptive
agent or adrenal cortex hormone)

4. pregnancy

5. acute coronary syndrome, acute myocardial infarction or undergone a revascularization
procedure within 6 months

6. 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

7. nephrotic syndrome or serum creatinine (Cr) (≥179 µmol/L) and creatine phosphokinase
(CK) more than 3-fold the upper normal limit

8. primary hypothyroidism

9. psychiatric patients and HIV-infected patients

10. poorly controlled hypertension, as indicated by a Systolic Blood Pressure >180 mmHg or
Diastolic Blood Pressure >110 mmHg

11. 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.