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

This study has been completed.
Sponsor:
Information provided by:
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT00973115
First received: September 6, 2009
Last updated: September 8, 2009
Last verified: September 2009
History of Changes
  Purpose

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 Intervention Phase
Hyperlipidemia
 Drug: Simvastatin CR
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
Drug Information available for: Simvastatin
U.S. FDA Resources

Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:
  • the percent change from baseline in LDL cholesterol [ Time Frame: week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 132
Study Start Date: November 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Simvastatin CR 20mg- morning administration Drug: Simvastatin CR
Active Comparator: Simvastatin CR 20mg- evening administration Drug: Simvastatin CR

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00973115

Locations
Korea, Republic of
8 Sites
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
Principal Investigator: Seong-Hoon Park, M.D., Ph.D Ehwa Womans University Mokdong Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00973115     History of Changes
Other Study ID Numbers: HM-SIM-302
Study First Received: September 6, 2009
Last Updated: September 8, 2009
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin
Hypolipidemic Agents
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013