Trial | NCT00738296  Report issue

Official Title

Vytorin on Carotid Intima-media Thickness and Overall Rigidity

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    90
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.
Study Started
Apr 30
2005
Primary Completion
Dec 31
2005
Study Completion
Dec 31
2005
Last Update
Jun 24
2015
Estimate

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 names: 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

A Active Comparator

Group A: Comparator

B Active Comparator

Group B: Comparator

C Experimental

Group C: Drug

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
No Results Posted