Efficacy and Safety of Morning Versus Evening Intake of S... | NCT00973115

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

NCT00973115

Sponsor

Hanmi Pharmaceutical Company Limited

Status

Completed

Last Update Posted

Oct 12, 2016Estimated

Enrollment

132Actual

Phase

Phase 3

Conditions

Hyperlipidemia

Interventions

Simvastatin CR

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Aug 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Sep 6, 2009

First Submission Date that Met QC Criteria

Sep 8, 2009

First Posted Date

Sep 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2016

Last Update Posted Date

Oct 12, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

132Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Simvastatin CR 20mg- morning administration	Experimental		Drug: Simvastatin CR
Simvastatin CR 20mg- evening administration	Active Comparator		Drug: Simvastatin CR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Simvastatin CR	Drug		Simvastatin CR 20mg- evening administration Simvastatin CR 20mg- morning administration

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the percent change from baseline in LDL cholesterol		week 8

Secondary Outcomes

Measure	Description	Time Frame
the change and the percent change from baseline for total cholesterol, HDL cholesterol, Triglyceride, apolipoprotein A-I, apolipoprotein B, and lipoprotein(a)		week 8

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Seong-Hoon Park, M.D., Ph.D	Ehwa Womans University Mokdong Hospital	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D006949	Hyperlipidemias

Ancestor Terms

ID	Term
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided