Vascular and Metabolic Effects of Vytorin vs Simvastatin | NCT01666067

Studies
Vascular and Metabolic Effects of Vytorin vs Simvastatin

NCT01666067

Sponsor

Gachon University Gil Medical Center

Status

Completed

Last Update Posted

Nov 4, 2014Estimated

Enrollment

204Actual

Phase

Phase 4

Conditions

Hypercholesterolemia

Interventions

placebo
vytorin
simvastatin

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

Aug 2012

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 2011

Primary Completion Date

Oct 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

Aug 15, 2012

First Submission Date that Met QC Criteria

Aug 15, 2012

First Posted Date

Aug 16, 2012Estimated

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

Nov 1, 2014

Last Update Posted Date

Nov 4, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kwang Kon Koh, professor, Gachon University Gil Medical CenterPrincipal Investigator

Lead Sponsor

Gachon University Gil Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

204Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
placebo	Active Comparator	placebo	Drug: placebo
vytorin	Active Comparator	vytorin	Drug: vytorin
simvastatin	Active Comparator	simvastatin	Drug: simvastatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
placebo	Drug		placebo
vytorin

Measure	Description	Time Frame
flow-mediated dilation		8 weeks of treatment

Measure	Description	Time Frame
insulin resistance		8 weeks of treatment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

hypercholesterolemic patients (LDL cholesterol levels>100 mg/dl)

Exclusion Criteria:

overt liver disease, chronic renal failure, hypothyroidism, myopathy, uncontrolled diabetes (HbA1c > 9%), severe hypertension, stroke, acute coronary events, coronary revascularization within the preceding 3 months, or alcohol abuse

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gil Medical Center		Incheon		405-760	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D006937	Hypercholesterolemia
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069499	Ezetimibe, Simvastatin Drug Combination
D019821	Simvastatin

Ancestor Terms

ID	Term
D008148	Lovastatin
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided