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OpenTrials
Completed

NCT Number: NCT00973115

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

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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Key information

Conditions

Hyperlipidemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

8 Sites

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simvastatin CR

Drug

Primary outcomes

  1. the percent change from baseline in LDL cholesterol

    Time frame: week 8

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Sep 9, 2009
Registry last updated
Oct 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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