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Phase 2 A, Double-Blind, Randomized, Placebo-Controlled Trial Measuring the Effects of MLN1202 on C-Reactive Protein Levels in Patients With Risk Factors for Cardiovascular Disease
This study is a, randomized, double-blind, placebo-controlled phase 2a trial evaluating the potential of MLN1202 to reduce circulating levels of C-reactive protein (CRP)in patients with risk factors for Atherosclerotic cardiovascular disease (ASCVD). Patients with risk factors for ASCVD will be screened for inclusion and exclusion criteria including assessment of C-reactive protein. If the patient's CRP is greater than 3.0 mg/L on repeated measurements at least 2 weeks apart, the patient will be enrolled, stratified by screening CRP levels (≤5.0 mg/L and \>5.0 mg/L), and randomized to receive 1 dose of either placebo or MLN1202. Safety will be assessed by vital signs, physical examination, clinical laboratories at baseline, and adverse event (AE) reporting from Day 1 to Day 113 of the trial.
Details
| Lead sponsor | Millennium Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 108 |
| Start date | 2005-08 |
Conditions
- Atherosclerosis
Interventions
- MLN1202
- Placebo
Primary outcomes
- Evaluate the effect of C-C Chemokine Receptor-2 (CCR2) blockade in reducing Creactive protein (CRP) levels in patients with risk factors for atherosclerotic cardiovascular disease (ASCVD) and a baseline elevation of CRP — The change from baseline to Day 57 in CRP between patients treated withplacebo compared with MLN1202