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
  Purpose

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 Intervention Phase
Cardiovascular Diseases
Drug: ezetimibe (+) simvastatin
Drug: simvastatin
Drug: pravastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Vytorin on Carotid Intima-media Thickness and Overall Rigidity

Resource links provided by NLM:


Further study details as provided by Hospital Universitario 12 de Octubre:

Primary Outcome Measures:
  • The annual progression of the slope of the maximum average GIM and the arterial rigidity. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: April 2005
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00738296

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

No publications provided

Responsible Party: Alejandra Meaney Martinez, MD, PhD, Hospital Universitario 12 de Octubre
ClinicalTrials.gov Identifier: NCT00738296     History of Changes
Other Study ID Numbers: 2008_018, MK0653A-164
Study First Received: August 18, 2008
Last Updated: October 5, 2011
Health Authority: Mexico: Ministry of Health

Additional relevant MeSH terms:
Cardiovascular Diseases
Simvastatin
Pravastatin
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014