Phase 1
N=83
Evaluate the Utility of 18FDG-PET as a Tool to Quantify Atherosclerotic Plaque (MK-0000-081 AM3)(COMPLETED)
Atherosclerotic Vascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT00703261 ↗Enrolled (actual)
83
Serious AEs
2.4%
Results posted
Nov 2011
Primary outcome: Primary: Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment — 1.4; 5.8 Percent reduction — p=0.006
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- atorvastatin (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment |
1.4; 5.8 | 0.006 sig |
| SECONDARY Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment in Statin-naive Participants |
2.3 | 0.195 |
Summary
The purpose of this study is to evaluate the utility of 18Fluorine Fluorodeoxyglucose Positron Emission Tomography (18FDG-PET) as a tool to quantify atherosclerotic plaque.
Eligibility Criteria
Inclusion Criteria
- Male or Female ages 30 to 80
- Participant is on a low dose statin for at least 6 weeks prior to screening or is statin-naive at screening
Exclusion Criteria
- Participant has human immunodeficiency virus (HIV), Hepatitis B or C
- Participant uses illegal drugs
- Participant has Type I diabetes
- Participant has a history of claustrophobia
Data sourced from ClinicalTrials.gov (NCT00703261). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.