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A Randomized, Double-Blind Placebo- Controlled Phase 2a Study to Assess the Effect of CCR2 Antagonism by MLN1202 on Atherosclerotic Inflammation in Subjects With Stable Atherosclerotic Cardiovascular Disease Using FDG PET/CT Imaging
The purpose of this study is to evaluate the effect of MLN1202 on arterial inflammation in participants with stable atherosclerotic cardiovascular disease (CVD) who are receiving standard-of-care (SOC) therapy.
Details
| Lead sponsor | Takeda |
|---|---|
| Phase | Phase 2 |
| Status | WITHDRAWN |
| Start date | 2016-04 |
| Completion | 2016-04 |
Conditions
- Atherosclerotic Cardiovascular Disease
Interventions
- MLN1202
- Placebo
Primary outcomes
- The change in arterial FDG uptake from MLN1202 treatment relative to placebo, comparing pretreatment and 3 month post-treatment time points — Baseline and 3 month post-treatment
The primary imaging endpoint of interest is the FDG uptake, measured as a target to background ratio (TBR) within the most diseased segment (MDS) of the index vessel.