Evaluation of Atorvastatin Treatment on Carotid Plaque. | NCT00343655

Studies
Evaluation of Atorvastatin Treatment on Carotid Plaque.

NCT00343655

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Status

Terminated

Last Update Posted

Feb 18, 2021Actual

Enrollment

160

Phase

Phase 3

Conditions

Cardiovascular Diseases

Interventions

Atorvastatin

Countries

United States

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

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study was terminated on June 22, 2007 for inability to enroll patients within an appropriate timeframe. There were no efficacy/safety concerns.

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Not provided

Completion Date

Aug 2007Actual

First Submitted Date

Jun 20, 2006

First Submission Date that Met QC Criteria

Jun 20, 2006

First Posted Date

Jun 23, 2006Estimated

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

Feb 17, 2021

Last Update Posted Date

Feb 18, 2021Actual

Description Module

Brief Summary

The purpose of the study is to evaluate the effect of 18 months treatment with atorvastatin 80mg or atorvastatin 10mg on the carotid vessel plaque morphology, in particular, the effect on evident necrotic lipid rich core of the plaque in patients.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160

Name	Type	Description	Arm Group Labels	Other Names
Atorvastatin	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in lipid pool volume from baseline to 18 months in response to atorvastatin 80mg.
Comparison of effect of atorvastatin 80mg versus 10mg

Secondary Outcomes

Measure	Description	Time Frame
Correlation of MRI measure of carotid morphology with cIMT measured by B-mode US.
Correlation of MRI measure of carotid morphology with DS-CT measure of coronary morphology.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with measurable carotid plaque with lipid and are eligible for statin therapy.

Exclusion Criteria:

Subjects at higher risk for cardiovascular disease with a screen LDL-cholesterol greater than 120 mg/dL,
Subjects currently on high dose statin, and
Subjects with contraindications for MRI or statin therapy.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 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
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Boston	Massachusetts	02114	United States

References Module

Citations

Not provided

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Term
D002318	Cardiovascular Diseases
D006937	Hypercholesterolemia