Safety and Tolerability of E5555 and Its Effects on Markers of Intravascular Inflammation in Subjects With Acute Coronary Syndrome
This study has been completed.
Information provided by (Responsible Party):
First received: October 22, 2007
Last updated: May 21, 2013
Last verified: September 2009
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomised, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of E5555, and Its Effects on Clinical Events and Biomarkers in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome|
Further study details as provided by Eisai Inc.:
Primary Outcome Measures:
- Safety and tolerability [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Incidence of Major Adverse Cardiovascular Events; Platelet Aggregation Inhibition; Holter Monitoring. Exploratory Outcome Measure: effects on endovascular inflammatory processes [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2007|
|Study Completion Date:||August 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
|Active Comparator: 1||
50 mg (one 50 mg active and two 100 mg placebo) tablets taken once daily for 12 weeks.
|Active Comparator: 2||
100 mg (one 50 mg placebo; one 100 mg active and one 100 mg placebo) tablet taken once daily for 12 weeks.
|Active Comparator: 3||
200 mg (one 50 mg placebo and two 100 mg active) tablets taken once daily for 12 weeks.
|Placebo Comparator: 4||
One 50 mg placebo and two 100 mg placebo tablets taken once daily for 12 weeks.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00548587
|United States, Wisconsin|
|Beloit Clinic, SC|
|Beloit, Wisconsin, United States, 53511-2230|
|Royal Brompton Hospital|
|London, United Kingdom, SW3 6NP|
Sponsors and Collaborators
|Study Director:||Rafal Ziecina, MD||Eisai Limited|