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

Phase 3

Completed

• Conditions: Hyperlipidemia
• Interventions: Drug: Simvastatin CR

• Registration Number: NCT00973115
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Study First Submitted: 2009-09-06
• Study First Submitted QC: 2009-09-08
• Study First Posted: 2009-09-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-10
• Last Update Posted: 2016-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simvastatin CR 20mg- evening administration	Simvastatin CR	-
Simvastatin CR 20mg- morning administration	Simvastatin CR	-

Primary Outcome Measures

Name	Time	Method
the percent change from baseline in LDL cholesterol	week 8

Secondary Outcome Measures

Name	Time	Method
the change and the percent change from baseline for total cholesterol, HDL cholesterol, Triglyceride, apolipoprotein A-I, apolipoprotein B, and lipoprotein(a)	week 8

Trial Locations

Locations (1)

8 Sites; 🇰🇷 Seoul, Korea, Republic of