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CompletedNCT01660945Updated Nov 4, 2014

Vascular and Metabolic Effects of Vytorin

A Phase 4 interventional study of placebo and vytorin in Hypercholesterolemia, sponsored by Gachon University Gil Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 25 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-11-04.

Sponsored by Gachon University Gil Medical Center · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
204
Allocation
Randomized
Ages
25 Years to 80 Years
Sex
All
01

Study summary

The investigator hypothesize that vytorin may improve vascular and insulin resistance in hypercholesterolemic patients

02

Conditions studied

  • Hypercholesterolemia

Keywords

  • statins, insulin resistance
03

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 110 are open to participants now.

This study's enrollment of 204 is above the median of 100 across 992 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

Gachon University Gil Medical Center is the lead sponsor of 88 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • hypercholesterolemia

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
204 participants (actual)

Study arms

  • Placebo comparator
    placebo

    placebo

    Drug: placebo

  • Active comparator
    vytorin 10

    vytorin 10 mg

    Drug: vytorin

  • Active comparator
    vytorin 20

    vytorin 20 mg

    Drug: vytorin

Interventions

  • Drugplacebo
  • Drugvytorin
06

What researchers measure

Primary outcomes

  1. flow-mediated dilation

    Time frame: 8 weeks of treatment

Secondary outcomes

  1. insulin resistance

    Time frame: 8 weeks of treatment

07

Study locations

1 site
  • Gil Medical Center
    Incheon, 405-760, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01660945
Lead sponsor
Gachon University Gil Medical Center
Responsible party
Kwang Kon Koh (professor, Gachon University Gil Medical Center) — Principal investigator
First posted
Aug 9, 2012
Start date
Jul 2011
Primary completion
Jul 2012
Completion
Nov 2012
Last update
Nov 4, 2014

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

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