Evaluation of Atorvastatin Treatment on Carotid Plaque.
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT00343655
Collaborator
(none)
160
1
7
23
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A Randomized Clinical Trial Of Atorvastatin 10 Mg And 80 Mg In The Reversal Of Or Stabilization Of Carotid Atheroma Lipid Pool
Study Start Date
:
Jan 1, 2007
Actual Study Completion Date
:
Aug 1, 2007
Outcome Measures
Primary Outcome Measures
- Change in lipid pool volume from baseline to 18 months in response to atorvastatin 80mg. []
- Comparison of effect of atorvastatin 80mg versus 10mg []
Secondary Outcome Measures
- 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. []
- Correlation of biomarkers to carotid changes. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00343655
Other Study ID Numbers:
- A2581152
First Posted:
Jun 23, 2006
Last Update Posted:
Feb 18, 2021
Last Verified:
Feb 1, 2021
Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Additional relevant MeSH terms: