Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00312052
Recruitment Status : Completed
First Posted : April 7, 2006
Last Update Posted : December 5, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: E5555 Drug: Placebo Phase 2

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of E5555, and Its Effects on Markers of Intravascular Inflammation in Subjects With Coronary Artery Disease
Study Start Date : September 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: E5555 50 mg
Participants received one 50 mg E5555 and two 100 mg placebo tablets, once orally daily for 24 weeks.
Drug: E5555
50 mg or 100 mg E5555 tablets

Drug: Placebo
50 mg and/or 100 mg placebo tablets

Experimental: E5555 100 mg
Participants received one 50 mg placebo, one 100 mg E5555 and one 100 mg placebo tablets, once orally daily for 24 weeks.
Drug: E5555
50 mg or 100 mg E5555 tablets

Drug: Placebo
50 mg and/or 100 mg placebo tablets

Active Comparator: E5555 200 mg
Participants received one 50 mg placebo and two 100 mg E5555 tablets were taken orally once daily for 24 weeks.
Drug: E5555
50 mg or 100 mg E5555 tablets

Drug: Placebo
50 mg and/or 100 mg placebo tablets

Placebo Comparator: Placebo
Participants received one 50 mg placebo and two 100 mg placebo tablets, once orally daily for 24 weeks.
Drug: Placebo
50 mg and/or 100 mg placebo tablets




Primary Outcome Measures :
  1. Safety and tolerability - especially the risk of bleeding [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Incidence of major adverse cardiovascular events; the effect on platelet aggregation inhibition. Exploratory Outcome Measure: effects on endovascular inflammatory processes [ Time Frame: 6 months ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  1. Males or Females, 45 - 80 years of age
  2. Confirmed coronary artery disease defined as one of the following:

    • Post-acute coronary syndrome or myocardial infarction or
    • Post percutaneous coronary intervention or coronary artery bypass graft or oAngina pectoris with documented (electrocardiogram or imaging study) ischemia or
    • Angiographically documented lesion occluding ≥70% of a coronary vessel

    And at high risk as defined as one or more of the following:

    • Elevated hsCRP (high-sensitivity C-reactive protein)
    • Diabetes mellitus
    • History of carotid artery disease and/or peripheral artery disease
    • Thrombo-embolic transient ischemic attack or stroke >1 year prior to screening
  3. All subjects must be receiving low dose aspirin and/or clopidogrel and/or ticlopidine.

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 or known structural cerebral vascular lesion
  3. Clinically significant hematological, hepatic or renal abnormalities
  4. Patients with some specific ST-segment changes, severe congestive heart failure or uncontrolled cardiac arrhythmias at baseline
  5. Recent significant (as determined by the investigator) cardiovascular events

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00312052


Locations
Layout table for location information
United States, Florida
Florida Research Network
Gainesville, Florida, United States, 32605
United States, Michigan
Great Lakes Heart Center of Alpena
Alpena, Michigan, United States, 49707
Sponsors and Collaborators
Eisai Inc.
Investigators
Layout table for investigator information
Study Director: John Riefler, MD Eisai Limited

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00312052     History of Changes
Other Study ID Numbers: E5555-G000-201
2005-006029-94 ( EudraCT Number )
First Posted: April 7, 2006    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: November 2016

Keywords provided by Eisai Inc.:
Coronary Artery Disease

Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Inflammation
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases