CClinicalTrials.gg
TerminatedNCT00343655Updated Feb 18, 2021

Evaluation of Atorvastatin Treatment on Carotid Plaque.

A Phase 3 interventional study of Atorvastatin in Cardiovascular Diseases, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Terminated at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-18.

Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 3, Interventional, and Treatment

Why this study was terminated
The study was terminated on June 22, 2007 for inability to enroll patients within an appropriate timeframe. There were no efficacy/safety concerns.
Phase
Phase 3
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cardiovascular Diseases

Keywords

  • Hypercholesterolemia
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 160 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
160 participants

Interventions

  • DrugAtorvastatin
06

What researchers measure

Primary outcomes

  1. Change in lipid pool volume from baseline to 18 months in response to atorvastatin 80mg.

  2. Comparison of effect of atorvastatin 80mg versus 10mg

Secondary outcomes

  1. Correlation of MRI measure of carotid morphology with cIMT measured by B-mode US.

  2. Correlation of MRI measure of carotid morphology with DS-CT measure of coronary morphology.

  3. Correlation of biomarkers to carotid changes.

07

Study locations

1 site
  • Pfizer Investigational Site
    Boston, Massachusetts 02114, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00343655
Lead sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Responsible party
Sponsor
First posted
Jun 23, 2006
Start date
Jan 2007
Completion
Aug 2007
Last update
Feb 18, 2021

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion