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

Efficacy and Safety of Morning Versus Evening Intake of Simvast CR Tablet in Patients With Hyperlipidemia: A Randomized, Double-blind, Multicenter Phase 3 Trial

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00973115

Enrollment

132

Registered

2009-09-09

Start date

2007-11-30

Completion date

2009-08-31

Last updated

2016-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemia

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.

Interventions

DRUGSimvastatin CR

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
the percent change from baseline in LDL cholesterol	week 8

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026