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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Atherosclerotic Vascular Disease

Treatments: Drug: atorvastatin; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00703261

2007_651

0000-081

Details and patient eligibility

About

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.

Enrollment: 83 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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83 participants in 2 patient groups

10 mg Atorvastatin

Active Comparator group

Description:

10 mg atorvastatin + placebo

Treatment:

Drug: atorvastatin

Drug: placebo

80 mg Atorvastatin

Active Comparator group

Description:

80 mg atorvastatin + placebo

Treatment:

Drug: atorvastatin

Drug: placebo