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Vascular and Metabolic Effects of Vytorin vs Simvastatin

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

placebo

vytorin

simvastatin

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring insulin resistance

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Gil Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

placebo

vytorin

simvastatin

Arm Description

placebo

vytorin

simvastatin

Outcomes

Primary Outcome Measures

flow-mediated dilation

Secondary Outcome Measures

insulin resistance

Full Information

NCT ID

NCT01666067

First Posted

August 15, 2012

Last Updated

November 1, 2014

Sponsor

Gachon University Gil Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01666067

Brief Title

Vascular and Metabolic Effects of Vytorin vs Simvastatin

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

November 2011 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Gachon University Gil Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The investigators hypothesize that vytorin will improve insulin resistance compared with simvastatin

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

Keywords

insulin resistance

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

204 (Actual)

8. Arms, Groups, and Interventions

Arm Title

placebo

Arm Type

Active Comparator

Arm Description

placebo

Arm Title

vytorin

Arm Type

Active Comparator

Arm Description

vytorin

Arm Title

simvastatin

Arm Type

Active Comparator

Arm Description

simvastatin

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Type

Drug

Intervention Name(s)

vytorin

Intervention Type

Drug

Intervention Name(s)

simvastatin

Primary Outcome Measure Information:

Title

flow-mediated dilation

Time Frame

8 weeks of treatment

Secondary Outcome Measure Information:

Title

insulin resistance

Time Frame

8 weeks of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Gil Medical Center

City

Incheon

ZIP/Postal Code

405-760

Country

Korea, Republic of

12. IPD Sharing Statement

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Vascular and Metabolic Effects of Vytorin vs Simvastatin

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