NCT00312052

Safety and Tolerability of E5555 and Its Effects on Markers of Intravascular Inflammation in Subjects With Coronary Artery Disease

A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of E5555, and Its Effects on Markers of Intravascular Inflammation in Subjects With Coronary Artery Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 720 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to assess the safety and tolerability of E5555 in subjects with coronary artery disease.

Detailed description

This was a multicenter, randomized, double-blind, placebo-controlled trial of E5555, a PAR-1 inhibitor. The total duration of individual study participation was 28 weeks (196 days). This included a treatment period of 24 weeks (168 days) and a follow-up period of 4 weeks (28 days).

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	E5555	50 mg or 100 mg E5555 tablets
DRUG	Placebo	50 mg and/or 100 mg placebo tablets

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-03-01
• Completion: 2009-08-01
• First posted: 2006-04-07
• Last updated: 2016-12-05

Locations

2 sites across 1 country: United States