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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Simvastatin CR 20mg- morning administration

Group Type EXPERIMENTAL

Simvastatin CR

Intervention Type DRUG

Simvastatin CR 20mg- evening administration

Group Type ACTIVE_COMPARATOR

Simvastatin CR

Intervention Type DRUG

Interventions

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Simvastatin CR

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No