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

Hyperlipidemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00973115
• Other study ID #: HM-SIM-302
• Status: Completed
• Phase: Phase 3
• First received: September 6, 2009
• Last updated: October 10, 2016
• Start date: November 2007
• Est. completion date: August 2009

Study information

• Verified date: October 2016
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias

Intervention

Drug:
• Simvastatin CR

Locations

Country	Name	City	State
Korea, Republic of	8 Sites	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the percent change from baseline in LDL cholesterol		week 8	No
Secondary	the change and the percent change from baseline for total cholesterol, HDL cholesterol, Triglyceride, apolipoprotein A-I, apolipoprotein B, and lipoprotein(a)		week 8	No