Vytorin on Carotid Intima-media Thickness and Overall Rigidity (VYCTOR)
This study has been completed.
Sponsor:
Hospital Universitario 12 de Octubre
Collaborator:
Merck
Information provided by (Responsible Party):
Alejandra Meaney Martinez, Hospital Universitario 12 de Octubre
ClinicalTrials.gov Identifier:
NCT00738296
First received: August 18, 2008
Last updated: October 5, 2011
Last verified: August 2008
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Vytorin on Carotid Intima-media Thickness and Overall Rigidity |
Resource links provided by NLM:
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 |
|---|---|
|
Active Comparator: A
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
Other Name: Zocor
|
|
Active Comparator: B
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
|
|
Experimental: C
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
Other Names:
|
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 More Information
No publications provided
| Responsible Party: | Alejandra Meaney Martinez, MD, PhD, Hospital Universitario 12 de Octubre |
| ClinicalTrials.gov Identifier: | NCT00738296 History of Changes |
| Other Study ID Numbers: | 2008_018, MK0653A-164 |
| Study First Received: | August 18, 2008 |
| Last Updated: | October 5, 2011 |
| Health Authority: | Mexico: Ministry of Health |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Simvastatin Pravastatin Ezetimibe Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013