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