Phase 1 Completed N=83 Randomized Double-blind Treatment

Evaluate the Utility of 18FDG-PET as a Tool to Quantify Atherosclerotic Plaque (MK-0000-081 AM3)(COMPLETED)

Source: ClinicalTrials.gov NCT00703261 ↗

Enrolled (actual)

Serious AEs

2.4%

Results posted

Nov 2011

Primary outcomePrimary: Percent Reduction From Baseline in TBRmeanmax of the Qualifying Segment — 1.4; 5.8 Percent reduction — p=0.006

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.

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

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.