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Vascular and Metabolic Effects of Vytorin

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
placebo
vytorin
Sponsored by
Gachon University Gil Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • hypercholesterolemia

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

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

placebo

vytorin 10

vytorin 20

Arm Description

placebo

vytorin 10 mg

vytorin 20 mg

Outcomes

Primary Outcome Measures

flow-mediated dilation

Secondary Outcome Measures

insulin resistance

Full Information

First Posted
August 8, 2012
Last Updated
November 1, 2014
Sponsor
Gachon University Gil Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01660945
Brief Title
Vascular and Metabolic Effects of Vytorin
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
July 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 investigator hypothesize that vytorin may improve vascular and insulin resistance in hypercholesterolemic patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
statins, 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
Placebo Comparator
Arm Description
placebo
Arm Title
vytorin 10
Arm Type
Active Comparator
Arm Description
vytorin 10 mg
Arm Title
vytorin 20
Arm Type
Active Comparator
Arm Description
vytorin 20 mg
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Type
Drug
Intervention Name(s)
vytorin
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
No
Eligibility Criteria
Inclusion Criteria: hypercholesterolemia 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

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