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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014