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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00973115
Recruitment Status : Completed
First Posted : September 9, 2009
Last Update Posted : October 12, 2016
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Hyperlipidemia Drug: Simvastatin CR Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Morning Versus Evening Intake of Simvast CR Tablet in Patients With Hyperlipidemia: A Randomized, Double-blind, Multicenter Phase 3 Trial
Study Start Date : November 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin

Arm Intervention/treatment
Experimental: Simvastatin CR 20mg- morning administration Drug: Simvastatin CR
Active Comparator: Simvastatin CR 20mg- evening administration Drug: Simvastatin CR

Primary Outcome Measures :
  1. the percent change from baseline in LDL cholesterol [ Time Frame: week 8 ]

Secondary Outcome Measures :
  1. the change and the percent change from baseline for total cholesterol, HDL cholesterol, Triglyceride, apolipoprotein A-I, apolipoprotein B, and lipoprotein(a) [ Time Frame: week 8 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00973115

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Korea, Republic of
8 Sites
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
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Principal Investigator: Seong-Hoon Park, M.D., Ph.D Ehwa Womans University Mokdong Hospital
Layout table for additonal information Identifier: NCT00973115    
Other Study ID Numbers: HM-SIM-302
First Posted: September 9, 2009    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors