Vytorin on Carotid Intima-media Thickness and Overall Rigidity

Cardiovascular Diseases Clinical Trial

— VYCTOR  

Official title:

Vytorin on Carotid Intima-media Thickness and Overall Rigidity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00738296
• Other study ID #: 2008_018
• Secondary ID: MK0653A-164
• Status: Completed
• Phase: Phase 4
• First received: August 18, 2008
• Last updated: June 23, 2015
• Start date: April 2005
• Est. completion date: December 2005

Study information

• Verified date: August 2008
• Source: Hospital Regional 1o de Octubre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitario 12 de Octubre	Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The annual progression of the slope of the maximum average GIM and the arterial rigidity.		1 Year	No