Vytorin on Carotid Intima-Media Thickness and Overall Rigidity - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 18, 2008

Last Updated Date

September 23, 2008

Start Date ^†

April 2005

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00738296 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Vytorin on Carotid Intima-Media Thickness and Overall Rigidity

Official Title ^†

Vytorin on Carotid Intima-Media Thickness and Overall Rigidity

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.

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Cardiovascular Diseases

Intervention ^†

Drug: ezetimibe (+) simvastatin
Drug: simvastatin
Drug: pravastatin

Study Arms / Comparison Groups

Active Comparator: Group A: Comparator
Active Comparator: Group B: Comparator
Experimental: Group C: Drug

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

December 2005

Primary Completion Date

December 2005 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

30 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00738296

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Secondary IDs ^††

MK0653A-164

Study Sponsor ^†

Hospital Universitario 12 de Octubre

Collaborators ^††

Merck

Investigators ^†

Study Director:

Medical Monitor

Merck

Information Provided By

Hospital Universitario 12 de Octubre

Verification Date

August 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.