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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00548587
First received: October 22, 2007
Last updated: January 5, 2016
Last verified: November 2015
  Purpose
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).

Condition Intervention Phase
Acute Coronary Syndrome
Drug: E5555
Drug: Placebo
Phase 2

Study Type: Interventional
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 ]

Enrollment: 600
Study Start Date: October 2007
Study Completion Date: August 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Participants will receive one 50 mg E5555 tablet and two 100 mg placebo tablets, once daily for 12 weeks.
Drug: E5555 Drug: Placebo
Active Comparator: 2
Participants will receive one 50 mg placebo tablet, one 100 mg E5555 tablet, and one 100 mg placebo tablet, once daily for 12 weeks.
Drug: E5555 Drug: Placebo
Active Comparator: 3
Participants will receive one 50 mg placebo tablet and two 100 mg E5555 tablets, once daily for 12 weeks.
Drug: E5555 Drug: Placebo
Placebo Comparator: 4
Participants will receive one 50 mg placebo tablet and two 100 mg placebo tablets, once daily for 12 weeks.
Drug: Placebo

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  1. Males or Females, 45 - 80 years of age
  2. Presenting with features of non-ST segment elevation ACS (unstable angina or Myocardial infarction without persistent ST elevation). and at least one of the following two criteria on admission: Cardiac enzymes≥ ULN for the local institution OR ECG changes compatible with ischemia
  3. Randomisation possible within 24 hours of the onset of the most recent symptomatic episode.

EXCLUSION CRITERIA:

  1. History of acquired or congenital bleeding disorder, coagulopathy or platelet disorder, or history of pathological bleeding within the last 6 months
  2. History of intracranial bleeding, history of hemorrhagic retinopathy, history of recent ischemic stroke or transient ischemic attack, or known structural cerebral vascular lesion
  3. Recent trauma, major surgery, Percutaneous coronary intervention or coronary artery surgery
  4. Clinically significant haematological, hepatic or renal abnormalities
  5. Patients with some specific ST-segment changes, severe congestive heart failure or uncontrolled cardiac arrhythmias at baseline
  6. Recent significant (as determined by the investigator) cardiovascular events
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548587

Locations
United States, Wisconsin
Beloit Clinic, SC
Beloit, Wisconsin, United States, 53511-2230
United Kingdom
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Rafal Ziecina, MD Eisai Limited
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00548587     History of Changes
Other Study ID Numbers: E5555-G000-202  2006-000296-15 
Study First Received: October 22, 2007
Last Updated: January 5, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
Acute Coronary Syndrome

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on December 07, 2016