Vytorin on Carotid Intima-Media Thickness and Overall Rigidity - Full Text View

Purpose

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.

Condition	Intervention	Phase
Cardiovascular Diseases	Drug: ezetimibe (+) simvastatin Drug: simvastatin Drug: pravastatin	Phase IV

ChemIDplus related topics:

Pravastatin Pravastatin sodium Simvastatin Ezetimibe Vytorin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Vytorin on Carotid Intima-Media Thickness and Overall Rigidity

Further study details as provided by Hospital Universitario 12 de Octubre:

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 ]

Enrollment:	90
Study Start Date:	April 2005
Study Completion Date:	December 2005
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Group A: Comparator	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
B: Active Comparator Group B: Comparator	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
C: Experimental Group C: Drug	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

Eligibility

Ages Eligible for Study:	30 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738296

Sponsors and Collaborators

Hospital Universitario 12 de Octubre

Merck

Investigators


Study Director:	Medical Monitor	Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_018, MK0653A-164
First Received:	August 18, 2008
Last Updated:	September 23, 2008
ClinicalTrials.gov Identifier:	NCT00738296
Health Authority:	Mexico: Ministry of Health

Study placed in the following topic categories:

Pravastatin

Simvastatin

Muscle Rigidity

Ezetimibe

Additional relevant MeSH terms:

Antimetabolites

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Antilipemic Agents

Enzyme Inhibitors

Cardiovascular Diseases

Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 15, 2008

Sponsors and Collaborators:	Hospital Universitario 12 de Octubre Merck
Information provided by:	Hospital Universitario 12 de Octubre
ClinicalTrials.gov Identifier:	NCT00738296