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Vytorin on Carotid Intima-media Thickness and Overall Rigidity (VYCTOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00738296
Recruitment Status : Completed
First Posted : August 20, 2008
Last Update Posted : June 24, 2015
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Alejandra Meaney Martinez, Hospital Universitario 12 de Octubre

Brief Summary:
Comparison of the effect on the progression of the carotid intima-media interphase thickness (GIM), arterial rigidity according to the measurement of the pulse wave speed and direct measurement of the carotid and aortic rigidities and an inflammation marker (PCR) in patients with established cardiovascular disease (myocardial infarct, atherosclerotic coronary disease), diabetes mellitus type 2 or equivalent risk of coronary disease and a low density lipoprotein level > 100 mg/dL, treated with simvastatin, pravastatin or the combination of simvastatin-ezetimibe during a period of at least one year.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Drug: ezetimibe (+) simvastatin Drug: simvastatin Drug: pravastatin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Vytorin on Carotid Intima-media Thickness and Overall Rigidity
Study Start Date : April 2005
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin

Arm Intervention/treatment
Active Comparator: A
Group A: Comparator
Drug: simvastatin
Patients will receive 40mg od. With the possibility to escalate the dose to 80 mg o.d. if therapeutic goals not attained; for 1 year. Tablets
Other Name: Zocor

Active Comparator: B
Group B: Comparator
Drug: pravastatin
Patients will receive pravastatin 40 mg o.d. with the possibility to add up 10mg of ezetimibe daily if LDL-C goal is not achieved; for 1 year. Tablets

Experimental: C
Group C: Drug
Drug: ezetimibe (+) simvastatin
Patients will receive the combination of ezetimibe/simvastatin 10/20 mg o.d. with the possibility to increase the dose to 10/40 mg o.d. for 1 year. Tablets
Other Names:
  • MK0653A
  • Vytorin

Primary Outcome Measures :
  1. The annual progression of the slope of the maximum average GIM and the arterial rigidity. [ Time Frame: 1 Year ]

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ldl-C Levels >100 Mg/Dl
  • Patients Who Have Signed The Consent
  • Patients Of ages between 30 and 75 Years Old
  • Patients Of Both Genders
  • Patients With Established Cardiovascular Disease, Diabetes With Or Without Established Cardiovascular Disease
  • Patients Without Previous Treatment With Ezetimibe

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 identifier (NCT number): NCT00738296

Sponsors and Collaborators
Hospital Universitario 12 de Octubre
Merck Sharp & Dohme Corp.
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Principal Investigator: Alejandra Meaney, MD, PhD Hospital Regional 1o de Octubre, ISSSTE

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Responsible Party: Alejandra Meaney Martinez, MD, PhD, Hospital Universitario 12 de Octubre Identifier: NCT00738296     History of Changes
Other Study ID Numbers: 2008_018
First Posted: August 20, 2008    Key Record Dates
Last Update Posted: June 24, 2015
Last Verified: August 2008

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