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Efficacy and Safety Study of Binodenoson in Assessing Cardiac Ischemia

Last updated on December 12, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Coronary Artery Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
30 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Able to understand and sign an informed consent form.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Women who are of childbearing potential.

- Very low likelihood of coronary artery disease (by American Heart Association and
American College of Cardiology standards).

- Documented history of acute myocardial infarction within 30 days.

- Percutaneous coronary intervention or coronary bypass graft surgery within 3 years,
unless typical or atypical anginal symptoms are present.

- Reactive airway disease or other contraindication that preclude a patient from
receiving adenosine.

- Previous heart transplant or listed to receive a heart transplant.

- Cardiomyopathy (idiopathic dilated, restrictive, hypertrophic).

- History of hemodynamically significant supraventricular tachycardia or sustained
ventricular tachycardia.

- Presence of second- or third-degree AV block (in the absence of permanent pacemaker).

- Left ventricular ejection fraction greater than 35%, known prior to the first imaging
procedure.

- Presence of advanced heart failure, New York Heart Association Class IV.

- History of vasospastic/Prinzmetal angina.

- Active (under treatment) cancer (except skin cancers).

- Inability to discontinue antianginal medications, Aggrenox®, dipyridamole, and
xanthine-containing drugs and foods (including caffeine) as required prior to each
imaging procedure.

- Previous participation in a study of binodenoson.

- Any physical or psychosocial condition that, based on the Investigator's judgment,
would prevent the patient from completing the study.

NCT00944970
Pfizer
Completed
Efficacy and Safety Study of Binodenoson in Assessing Cardiac Ischemia

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Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of Binodenoson in Assessing Cardiac Ischemia
Official Title  ICMJE Vasodilator Induced Stress In CONcordance With Adenosine (VISION-305)
Brief Summary Binodenoson (an experimental drug) and adenosine (an FDA-approved drug that is currently used by doctors) are used to increase blood flow to the heart just like when a person exercises on a treadmill. Using imaging techniques, this increased blood flow can help determine if areas of the heart are not getting enough blood and oxygen during exercise. The purpose of the study is to determine if binodenoson is as good as adenosine in determining if there are areas of the heart not getting enough oxygen when blood flow to the heart is increased.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • Drug: binodenoson
    30-second intravenous injection (bolus) of binodenoson (1.5 mcg/kg) and a 6-minute intravenous infusion of placebo
    Other Name: CorVue
  • Drug: adenosine
    30-second intravenous injection (bolus) of placebo and a 6-minute intravenous infusion of adenosine (140 mcg/kg/minute)
Study Arms  ICMJE
  • binodenoson then adenosine
    binodenoson (experimental); adenosine (active comparator)
    Interventions:
    • Drug: binodenoson
    • Drug: adenosine
  • adenosine then binodenoson
    adenosine (active comparator); binodenoson (experimental)
    Interventions:
    • Drug: binodenoson
    • Drug: adenosine
  • Active Comparator: adenosine then adenosine
    Intervention: Drug: adenosine
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 22, 2009)
578
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2006
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Able to understand and sign an informed consent form.

Exclusion Criteria:

  • Women who are of childbearing potential.
  • Very low likelihood of coronary artery disease (by American Heart Association and American College of Cardiology standards).
  • Documented history of acute myocardial infarction within 30 days.
  • Percutaneous coronary intervention or coronary bypass graft surgery within 3 years, unless typical or atypical anginal symptoms are present.
  • Reactive airway disease or other contraindication that preclude a patient from receiving adenosine.
  • Previous heart transplant or listed to receive a heart transplant.
  • Cardiomyopathy (idiopathic dilated, restrictive, hypertrophic).
  • History of hemodynamically significant supraventricular tachycardia or sustained ventricular tachycardia.
  • Presence of second- or third-degree AV block (in the absence of permanent pacemaker).
  • Left ventricular ejection fraction greater than 35%, known prior to the first imaging procedure.
  • Presence of advanced heart failure, New York Heart Association Class IV.
  • History of vasospastic/Prinzmetal angina.
  • Active (under treatment) cancer (except skin cancers).
  • Inability to discontinue antianginal medications, Aggrenox®, dipyridamole, and xanthine-containing drugs and foods (including caffeine) as required prior to each imaging procedure.
  • Previous participation in a study of binodenoson.
  • Any physical or psychosocial condition that, based on the Investigator's judgment, would prevent the patient from completing the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00944970
Other Study ID Numbers  ICMJE MRE0470P-305
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Robert L. Rolleri, Pharm.D. King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
PRS Account Pfizer
Verification Date May 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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