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Vascular and Metabolic Effects of Rosuvastatin

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

placebo

rosuvastatin

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:

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 4

Arm Type

Placebo Comparator

Active Comparator

Arm Label

placebo

rosuvastatin 5

rosuvastatin 10

rosuvastatin 20

Arm Description

placebo

rosuvastatin 5 mg

rosuvastatin 10 mg

rosuvastatin 20 mg

Outcomes

Primary Outcome Measures

flow-mediated dilation

Secondary Outcome Measures

insulin resistance

Full Information

NCT ID

NCT01660919

First Posted

August 8, 2012

Last Updated

November 1, 2014

Sponsor

Gachon University Gil Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01660919

Brief Title

Vascular and Metabolic Effects of Rosuvastatin

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

December 2013 (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 rosuvastatin does-dependently worsens insulin sensitivity.

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

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

placebo

Arm Title

rosuvastatin 5

Arm Type

Active Comparator

Arm Description

rosuvastatin 5 mg

Arm Title

rosuvastatin 10

Arm Type

Active Comparator

Arm Description

rosuvastatin 10 mg

Arm Title

rosuvastatin 20

Arm Type

Active Comparator

Arm Description

rosuvastatin 20 mg

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Type

Drug

Intervention Name(s)

rosuvastatin

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: 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 Rosuvastatin

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