A Study to Examine MPI SPECT Imaging With BMS068645 and Adenosine Compared to Coronary Angiography

January 31, 2017 updated by: Forest Laboratories

A Phase 3, Parallel, Double Blind, Multicenter Trial to Examine Inducible Myocardial Perfusion Abnormality Detection With BMS068645 and Adenosine Stress SPECT Compared to Coronary Angiography

The purpose of the study is to determine whether BMS068645 is as effective as Adenosine SPECT at detecting blockages in heart arteries, and to determine if it will have fewer side effects

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

2000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35213
        • Local Institution
      • Huntsville, Alabama, United States, 35801
        • Local Institution
    • Arkansas
      • North Little Rock, Arkansas, United States, 72117
        • Local Institution
    • California
      • Northridge, California, United States, 91325
        • Local Institution
      • Rancho Mirage, California, United States, 92270
        • Local Institution
      • Santa Clara, California, United States, 95051
        • Local Institution
      • Santa Rosa, California, United States, 95405
        • Local Institution
      • Walnut Creek, California, United States, 94598
        • Local Institution
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • Local Institution
      • Guilford, Connecticut, United States, 06437
        • Local Institution
      • New Haven, Connecticut, United States, 06510
        • Local Institution
    • Delaware
      • Newark, Delaware, United States, 19713
        • Local Institution
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Local Institution
      • Gainesville, Florida, United States, 32608
        • Local Institution
      • Gainesville, Florida, United States, 32605
        • Local Institution
      • Gainesville, Florida, United States, 32607
        • Local Institution
      • Jacksonville, Florida, United States, 32207
        • Local Institution
      • Jacksonville, Florida, United States, 32257
        • Local Institution
      • Jacksonville Beach, Florida, United States, 32250
        • Local Institution
      • Jupiter, Florida, United States, 33458
        • Local Institution
      • Miami, Florida, United States, 33173
        • Local Institution
      • Safety Harbor, Florida, United States, 34695
        • Local Institution
      • Stuart, Florida, United States, 34996
        • Local Institution
      • Tamarac, Florida, United States, 33321
        • Local Institution
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Local Institution
    • Illinois
      • Aurora, Illinois, United States, 60504
        • Local Institution
      • Fox River Grove, Illinois, United States, 60021
        • Local Institution
      • La Grange, Illinois, United States, 60525
        • Local Institution
      • Peoria, Illinois, United States, 61603
        • Local Institution
      • Winfield, Illinois, United States, 60190
        • Local Institution
    • Indiana
      • Fort Wayne, Indiana, United States, 48604
        • Local Institution
      • Indianapolis, Indiana, United States, 46260
        • Local Institution
    • Kansas
      • Overland Park, Kansas, United States, 66209
        • Local Institution
    • Kentucky
      • Louisville, Kentucky, United States, 40205
        • Local Institution
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Local Institution
    • Maine
      • Auburn, Maine, United States, 04210
        • Local Institution
      • Scarborough, Maine, United States, 04074
        • Local Institution
      • South Portland, Maine, United States, 04106
        • Local Institution
    • Maryland
      • Westminster, Maryland, United States, 21157
        • Local Institution
    • Massachusetts
      • Ayer, Massachusetts, United States, 01432
        • Local Institution
    • Michigan
      • Grand Rapids, Michigan, United States, 49525
        • Local Institution
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Local Institution
      • St. Cloud, Minnesota, United States, 56303
        • Local Institution
      • St. Louis Park, Minnesota, United States, 55416
        • Local Institution
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Local Institution
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Local Institution
      • Kansas City, Missouri, United States, 64132
        • Local Institution
      • St. Louis, Missouri, United States, 63104
        • Local Institution
    • New York
      • Albany, New York, United States, 10025
        • Local Institution
      • New York, New York, United States, 10029
        • Local Institution
      • West Islip, New York, United States, 11795
        • Local Institution
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Local Institution
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Local Institution
      • Cleveland, Ohio, United States, 44195
        • Local Institution
      • Columbus, Ohio, United States, 43210
        • Local Institution
      • Lorain, Ohio, United States, 44053
        • Local Institution
      • Sandusky, Ohio, United States, 44870
        • Local Institution
      • Westlake, Ohio, United States, 44145
        • Local Institution
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Local Institution
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102
        • Local Institution
      • Wyomissing, Pennsylvania, United States, 19610
        • Local Institution
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • Local Institution
    • South Carolina
      • Simpsonville, South Carolina, United States, 29681
        • Local Institution
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Local Institution
      • Johnson City, Tennessee, United States, 37604
        • Local Institution
      • Nashville, Tennessee, United States, 37203
        • Local Institution
      • Nashville, Tennessee, United States, 37205
        • Local Institution
      • Oak Ridge, Tennessee, United States, 37830
        • Local Institution
    • Texas
      • Amarillo, Texas, United States, 79106
        • Local Institution
      • Houston, Texas, United States, 77090
        • Local Institution
      • Plano, Texas, United States, 75024
        • Local Institution
    • Virginia
      • Hopewell, Virginia, United States, 23860
        • Local Institution
      • Lynchburg, Virginia, United States, 24501
        • Local Institution
      • Richmond, Virginia, United States, 23230
        • Local Institution
      • Roanoke, Virginia, United States, 24015
        • Local Institution
    • Washington
      • Spokane, Washington, United States, 99204
        • Local Institution
    • Wisconsin
      • Wausau, Wisconsin, United States, 54401
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Referral for pharmacologic stress SPECT MPI
  • Have suspected Ischemic heart disease

Exclusion Criteria:

  • Acute myocardial Infarction, Coronary artery bypass graft, percutaneous coronary intervention within 30 days of enrollment
  • Severe asthma or COPD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Sensitivity and specificity of BMS068645 vs. adenosine; to be determined at the end of the study after enrollment is complete

Secondary Outcome Measures

Outcome Measure
Incidence of serious adverse events due to adenosine vs. BMS068645; incidence of adverse events due to adenosine vs. BMS068645; to be determined at the end of the study after enrollment, but with interim independent analysis by a safety monitoring board

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Investigators

  • Study Director: Mark Hibberd, MD, PhD, Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (ACTUAL)

March 1, 2006

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (ESTIMATE)

September 13, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 31, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMS068645-302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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