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

Phase 2

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: E5555; Drug: Placebo

• Registration Number: NCT00312052
• Lead Sponsor: Eisai Inc.

Brief 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).

Study Timeline

• Study First Submitted: 2006-04-05
• Study First Submitted QC: 2006-04-05
• Study First Posted: 2006-04-07
• Study Start: 2007-09
• Primary Completion: 2008-03
• Study Completion: 2009-08
• Disposition First Submitted: 2013-05-21
• Disposition First Submitted QC: 2013-05-21
• Disposition First Posted: 2013-05-29
• Status Verified: 2016-11
• Last Update Submitted: 2016-12-01
• Last Update Posted: 2016-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 720

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
E5555 50 mg	E5555	Participants received one 50 mg E5555 and two 100 mg placebo tablets, once orally daily for 24 weeks.
E5555 50 mg	Placebo	Participants received one 50 mg E5555 and two 100 mg placebo tablets, once orally daily for 24 weeks.
E5555 100 mg	E5555	Participants received one 50 mg placebo, one 100 mg E5555 and one 100 mg placebo tablets, once orally daily for 24 weeks.
E5555 100 mg	Placebo	Participants received one 50 mg placebo, one 100 mg E5555 and one 100 mg placebo tablets, once orally daily for 24 weeks.
E5555 200 mg	E5555	Participants received one 50 mg placebo and two 100 mg E5555 tablets were taken orally once daily for 24 weeks.
E5555 200 mg	Placebo	Participants received one 50 mg placebo and two 100 mg E5555 tablets were taken orally once daily for 24 weeks.
Placebo	Placebo	Participants received one 50 mg placebo and two 100 mg placebo tablets, once orally daily for 24 weeks.

Primary Outcome Measures

Name	Time	Method
Safety and tolerability - especially the risk of bleeding	6 months

Secondary Outcome Measures

Name	Time	Method
Incidence of major adverse cardiovascular events; the effect on platelet aggregation inhibition. Exploratory Outcome Measure: effects on endovascular inflammatory processes	6 months

Trial Locations

Locations (2)

Florida Research Network; 🇺🇸 Gainesville, Florida, United States

Great Lakes Heart Center of Alpena; 🇺🇸 Alpena, Michigan, United States