Overview

Double-Blind, Randomized, Placebo-Controlled Trial of MLN1202 on C-Reactive Protein Levels in Patients With Risk Factors for Cardiovascular Disease

Status:
Completed

Trial end date:
1969-12-31

Target enrollment:

Participant gender:

Summary

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.

Phase:

Phase 2

Details

Lead Sponsor:

Millennium Pharmaceuticals, Inc.

Treatments:

Antibodies, Monoclonal