NCT00715169

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atherosclerosis

Interventions

Type	Name	Description
DRUG	MLN1202	10 mg/kg dose of MLN1202 administered via IV infusion administered approximately 30 minutes to an hour
OTHER	Placebo	Placebo consist of 0.9% saline solution administered as a 10 mg/kg dose via IV infusion administered approximately 30 minutes to an hour

Timeline

• Start date: 2005-08-01
• Primary completion: 2006-04-01
• First posted: 2008-07-15
• Last updated: 2008-07-15