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Vascular and Metabolic Effects of Vytorin vs Simvastatin

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ClinicalTrials.gov Identifier: NCT01666067
Recruitment Status : Completed
First Posted : August 16, 2012
Last Update Posted : November 4, 2014
Information provided by (Responsible Party):
Kwang Kon Koh, Gachon University Gil Medical Center

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

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: placebo Drug: vytorin Drug: simvastatin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : November 2011
Primary Completion Date : October 2012
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: placebo
Drug: placebo
Active Comparator: vytorin
Drug: vytorin
Active Comparator: simvastatin
Drug: simvastatin

Primary Outcome Measures :
  1. flow-mediated dilation [ Time Frame: 8 weeks of treatment ]

Secondary Outcome Measures :
  1. insulin resistance [ Time Frame: 8 weeks of treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01666067

Korea, Republic of
Gil Medical Center
Incheon, Korea, Republic of, 405-760
Sponsors and Collaborators
Gachon University Gil Medical Center

Responsible Party: Kwang Kon Koh, professor, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT01666067     History of Changes
Other Study ID Numbers: GMC-201110
First Posted: August 16, 2012    Key Record Dates
Last Update Posted: November 4, 2014
Last Verified: August 2012

Keywords provided by Kwang Kon Koh, Gachon University Gil Medical Center:
insulin resistance

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Ezetimibe, Simvastatin Drug Combination
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors