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

Last updated: October 10, 2016
Sponsor: Hanmi Pharmaceutical Company Limited
Overall Status: Completed

Phase

3

Condition

Dyslipidemia

Elevated Triglycerides (Hypertriglyceridemia)

Hypertriglyceridemia

Treatment

N/A

Clinical Study ID

NCT00973115
HM-SIM-302
  • Ages 19-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged between 19 and 75

  • Defined as a fasting 100mg/dl≤ LDL cholesterol <220mg/dl and triglyceride level<400mg/dl

  • Need drug therapy by NCEP ATP III guideline

  • Signed informed consent

Exclusion

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 usecontraception while on study

  • Had participated other clinical trial within 4 weeks

  • Need systemic administration of corticosteroids intermittently

Study Design

Total Participants: 132
Study Start date:
November 01, 2007
Estimated Completion Date:
August 31, 2009

Connect with a study center

  • 8 Sites

    Seoul,
    Korea, Republic of

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.