Safety and Tolerability of E5555 and Its Effects on Markers of Intravascular Inflammation in Subjects With Acute Coronary Syndrome

Phase 2

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: E5555; Drug: Placebo

• Registration Number: NCT00548587
• Lead Sponsor: Eisai Inc.

Brief Summary

This is a multi-center, randomized, double-blind, placebo-controlled study to determine the safety and tolerability of E5555 in subjects with Acute coronary syndrome (ACS).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-22
• Study First Submitted QC: 2007-10-22
• Study First Posted: 2007-10-24
• Primary Completion: 2009-04
• 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: 2015-11
• Last Update Submitted: 2016-01-05
• Last Update Posted: 2016-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	E5555	Participants will receive one 50 mg E5555 tablet and two 100 mg placebo tablets, once daily for 12 weeks.
2	Placebo	Participants will receive one 50 mg placebo tablet, one 100 mg E5555 tablet, and one 100 mg placebo tablet, once daily for 12 weeks.
4	Placebo	Participants will receive one 50 mg placebo tablet and two 100 mg placebo tablets, once daily for 12 weeks.
2	E5555	Participants will receive one 50 mg placebo tablet, one 100 mg E5555 tablet, and one 100 mg placebo tablet, once daily for 12 weeks.
3	Placebo	Participants will receive one 50 mg placebo tablet and two 100 mg E5555 tablets, once daily for 12 weeks.
1	Placebo	Participants will receive one 50 mg E5555 tablet and two 100 mg placebo tablets, once daily for 12 weeks.
3	E5555	Participants will receive one 50 mg placebo tablet and two 100 mg E5555 tablets, once daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	Up to 16 weeks

Secondary Outcome Measures

Name	Time	Method
Incidence of Major Adverse Cardiovascular Events; Platelet Aggregation Inhibition; Holter Monitoring. Exploratory Outcome Measure: effects on endovascular inflammatory processes	Up to 16 weeks

Trial Locations

Locations (2)

Beloit Clinic, SC; 🇺🇸 Beloit, Wisconsin, United States

Royal Brompton Hospital; 🇬🇧 London, United Kingdom