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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Alejandra Meaney Martinez, Hospital Universitario 12 de Octubre
ClinicalTrials.gov Identifier:
NCT00738296
First received: August 18, 2008
Last updated: October 5, 2011
Last verified: August 2008

August 18, 2008
October 5, 2011
April 2005
December 2005   (final data collection date for primary outcome measure)
The annual progression of the slope of the maximum average GIM and the arterial rigidity. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00738296 on ClinicalTrials.gov Archive Site
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Vytorin on Carotid Intima-media Thickness and Overall Rigidity
Vytorin on Carotid Intima-media Thickness and Overall Rigidity

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Cardiovascular Diseases
  • 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
  • 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
  • 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
  • Active Comparator: A
    Group A: Comparator
    Intervention: Drug: simvastatin
  • Active Comparator: B
    Group B: Comparator
    Intervention: Drug: pravastatin
  • Experimental: C
    Group C: Drug
    Intervention: Drug: ezetimibe (+) simvastatin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
December 2005
December 2005   (final data collection date for primary outcome measure)

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
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00738296
2008_018, MK0653A-164
Not Provided
Alejandra Meaney Martinez, Hospital Universitario 12 de Octubre
Hospital Universitario 12 de Octubre
Merck Sharp & Dohme Corp.
Principal Investigator: Alejandra Meaney, MD, PhD Hospital Regional 1o de Octubre, ISSSTE
Hospital Universitario 12 de Octubre
August 2008

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