Back to resultsEfficacy and Safety of Morning Versus Evening Intake of Simvast Controlled Release (CR) Tablet in Patients With Hyperlipidemia
Primary Purpose
Hyperlipidemia
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Simvastatin CR
Sponsored by
About this trial
This is an interventional treatment trial for Hyperlipidemia
Eligibility 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
Sites / Locations
- 8 Sites
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Simvastatin CR 20mg- morning administration
Simvastatin CR 20mg- evening administration
Arm Description
Outcomes
Primary Outcome Measures
the percent change from baseline in LDL cholesterol
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)
Full Information
NCT ID
NCT00973115
First Posted
September 6, 2009
Last Updated
October 10, 2016
Sponsor
Hanmi Pharmaceutical Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT00973115
Brief Title
Efficacy and Safety of Morning Versus Evening Intake of Simvast Controlled Release (CR) Tablet in Patients With Hyperlipidemia
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hanmi Pharmaceutical Company Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Simvastatin CR 20mg- morning administration
Arm Type
Experimental
Arm Title
Simvastatin CR 20mg- evening administration
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Simvastatin CR
Primary Outcome Measure Information:
Title
the percent change from baseline in LDL cholesterol
Time Frame
week 8
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seong-Hoon Park, M.D., Ph.D
Organizational Affiliation
Ehwa Womans University Mokdong Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
8 Sites
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Morning Versus Evening Intake of Simvast Controlled Release (CR) Tablet in Patients With Hyperlipidemia
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