Vytorin on Carotid Intima-media Thickness and Overall Rig... | NCT00738296

Studies
Vytorin on Carotid Intima-media Thickness and Overall Rigidity

NCT00738296

Sponsor

Hospital Universitario 12 de Octubre

Status

Completed

Last Update Posted

Jun 24, 2015Estimated

Enrollment

90Actual

Phase

Phase 4

Conditions

Cardiovascular Diseases

Interventions

ezetimibe (+) simvastatin
simvastatin
pravastatin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
MK0653A-164

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2005

Primary Completion Date

Dec 2005Actual

Completion Date

Dec 2005Actual

First Submitted Date

Aug 18, 2008

First Submission Date that Met QC Criteria

Aug 18, 2008

First Posted Date

Aug 20, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2015

Last Update Posted Date

Jun 24, 2015Estimated

Name	Class
Merck Sharp & Dohme LLC	INDUSTRY

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The annual progression of the slope of the maximum average GIM and the arterial rigidity.		1 Year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alejandra Meaney, MD, PhD	Hospital Regional 1o de Octubre, ISSSTE	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069499	Ezetimibe, Simvastatin Drug Combination
D019821	Simvastatin
D017035	Pravastatin

Ancestor Terms

ID	Term
D008148	Lovastatin
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided