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VYCTOR: Vytorin on Carotid Intima-media Thickness and Overall Rigidity

Sponsor
Hospital Universitario 12 de Octubre (Other)
Overall Status
Completed
CT.gov ID
NCT00738296
Collaborator
Merck Sharp & Dohme LLC (Industry)
90
Enrollment
3
Arms
8
Duration (Months)

Study Details

Study Description

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
Phase 4

Study Design

Study Type:
Interventional
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 :
Apr 1, 2005
Actual Primary Completion Date :
Dec 1, 2005
Actual Study Completion Date :
Dec 1, 2005

Arms and Interventions

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 Names:
  • 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The annual progression of the slope of the maximum average GIM and the arterial rigidity. [1 Year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 75 Years
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Hospital Universitario 12 de Octubre
    • Merck Sharp & Dohme LLC

    Investigators

    • Principal Investigator: Alejandra Meaney, MD, PhD, Hospital Regional 1o de Octubre, ISSSTE

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alejandra Meaney Martinez, MD, PhD, Hospital Universitario 12 de Octubre
    ClinicalTrials.gov Identifier:
    NCT00738296
    Other Study ID Numbers:
    • 2008_018
    • MK0653A-164
    First Posted:
    Aug 20, 2008
    Last Update Posted:
    Jun 24, 2015
    Last Verified:
    Aug 1, 2008
    Additional relevant MeSH terms:
    Cardiovascular Diseases
    Simvastatin
    Ezetimibe
    Pravastatin

    Study Results

    No Results Posted as of Jun 24, 2015