Vytorin on Carotid Intima-media Thickness and Overall Rigidity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2005-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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A

Group A: Comparator

Group Type ACTIVE_COMPARATOR

simvastatin

Intervention Type DRUG

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

B

Group B: Comparator

Group Type ACTIVE_COMPARATOR

pravastatin

Intervention Type DRUG

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

C

Group C: Drug

Group Type EXPERIMENTAL

ezetimibe (+) simvastatin

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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MK0653A Vytorin Zocor

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No