Vytorin on Carotid Intima-media Thickness and Overall Rigidity

NCT00738296 | Completed Phase 4

• 2 other identifiers: 2008_018MK0653A-164
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• The annual progression of the slope of the maximum average GIM and the arterial rigidity.

  1 Year

Study Arms (3)

A

ACTIVE COMPARATOR

Group A: Comparator

Drug: simvastatin

B

ACTIVE COMPARATOR

Group B: Comparator

Drug: pravastatin

C

EXPERIMENTAL

Group C: Drug

Drug: ezetimibe (+) simvastatin

Interventions

ezetimibe (+) simvastatin 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

Also known as: MK0653A, Vytorin

C

simvastatin 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

Also known as: Zocor

A

pravastatin 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

B

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario 12 de Octubre: lead
• Merck Sharp & Dohme LLC: collaborator

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Ezetimibe, Simvastatin Drug Combination; Simvastatin; Pravastatin

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ezetimibe; Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Alejandra Meaney, MD, PhD

  Hospital Regional 1o de Octubre, ISSSTE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 18, 2008
• First Posted: August 20, 2008
• Study Start: April 1, 2005
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: June 24, 2015

Record last verified: 2008-08