Vascular and Metabolic Effects of Vytorin vs Simvastatin

This study is currently recruiting participants.
Verified August 2012 by Gachon University Gil Medical Center
Sponsor:
Information provided by:
Gachon University Gil Medical Center
ClinicalTrials.gov Identifier:
NCT01666067
First received: August 15, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted

August 15, 2012
August 15, 2012
November 2011
October 2012   (final data collection date for primary outcome measure)
flow-mediated dilation [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
insulin resistance [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Vascular and Metabolic Effects of Vytorin vs Simvastatin
Not Provided

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Hypercholesterolemia
  • Drug: placebo
  • Drug: vytorin
  • Drug: simvastatin
  • Active Comparator: placebo
    Intervention: Drug: placebo
  • Active Comparator: vytorin
    Intervention: Drug: vytorin
  • Active Comparator: simvastatin
    Intervention: Drug: simvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
25 Years to 80 Years
No
Contact: Kwang K Koh, MD,PhD kwangk@gilhospital.com
Korea, Republic of
 
NCT01666067
GMC-201110
Yes
Not Provided
Gachon University Gil Medical Center
Not Provided
Not Provided
Gachon University Gil Medical Center
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP