Efficacy and Safety of Morning Versus Evening Intake of Simvast Controlled Release (CR) Tablet in Patients With Hyperlipidemia

Hanmi Pharmaceutical

Status and phase

Completed

Phase 3

Conditions

Hyperlipidemia

Treatments

Drug: Simvastatin CR

Study type

Interventional

Funder types

Industry

Identifiers

NCT00973115

HM-SIM-302

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of morning versus evening intake of Simvastatin Controlled Release tablet 20mg for 8 weeks in patients with hyperlipidemia. This study will investigate equivalence of the low-density lipoprotein(LDL) cholesterol percent change.

Enrollment

132 patients

Sex

All

Ages

19 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Aged between 19 and 75
Defined as a fasting 100mg/dl≤ LDL cholesterol <220mg/dl and triglyceride level<400 mg/dl
Need drug therapy by NCEP ATP III guideline
Signed informed consent

Exclusion criteria

Has a hypersensitivity to HMG-CoA reductase inhibitor or simvastatin
Has a presence or history of alcohol abuse or drug abuse
Active gallbladder disease within 12 months
Pancreatitis or Hepatic dysfunction (ALT or AST levels > 2XUNL)
HbA1c≥ 9% in type 2 diabetes mellitus patients
SBP < 90mmHg or > 160mmHg
DBP < 50mmHg or > 100mmHg
Myocardial infarction or revascularization procedure within 6 months
Has significant cardiovascular disease
Malignant tumor within 5years
Has fibromyalgia, myopathy, rhabdomyolysis or acute myalgia
Uric acid level > 9 mg/dl
Thyroid stimulating hormone ≥ 2XUNL
Active peptic ulcer disease
CPK levels > 3XUNL
creatinine level > 2 mg/dl
Negative pregnancy test for women of childbearing age and agreement to use contraception while on study
Had participated other clinical trial within 4 weeks
Need systemic administration of corticosteroids intermittently