Study Evaluating GAP-486 in Non-Sustained Ventricular Tachycardia


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Study Location
Merced, California, 95340, United States


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Eligibility Criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Females and Males
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years


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ArrhythmiasStudy Evaluating GAP-486 in Non-Sustained Ventricular Tachycardia
  1. Merced, California
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  4. Peoria, Illinois
  5. Iowa City, Iowa
  6. Norfolk, Virginia
  7. Curitiba, PR
  8. Sao Jose, Rio Preto
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  26. Moose Jaw, Saskatchewan
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  35. Nyíri u. 38., H-6000 Kecskemét
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  53. Padilla, Veracruz
  54. Tlalpan,
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  76. Nottingham,
18 Years+
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating GAP-486 in Non-Sustained Ventricular Tachycardia
Official Title  ICMJE Study Evaluating Subjects With Non-Sustained Ventricular Tachycardia
Brief Summary To determine whether the administration of test article will decrease the occurrence of ventricular arrhythmias in patients who have acute coronary syndrome (unstable angina, ST segment elevated myocardial infarction or myocardial infarction without ST elevation).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE Arrhythmias
Intervention  ICMJE
  • Drug: Double-blind investigational anti-arrhythmic
  • Drug: GAP-486
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: July 26, 2005)
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE


  • Male and female patients, 18 years of age or older, that have experienced an acute ischemic event within 24 hours prior to study entry.
  • Patients with a documented history of coronary artery disease or left ventricular dysfunction
  • Patients who have experienced an episode of non-sustained ventricular tachycardia within 24 hours of the index ischemic event


  • Patients who have had percutaneous coronary intervention (PCI), thrombolytics, or open-heart surgery within 48 hours prior to study entry, or who require it during test article administration
  • Patients who have taken another antiarrhythmic medication (other than a beta blocker) within 5 half-lives of the start of test article
  • Patients who have a history of torsades de pointes, long QT syndrome, QTc > 0.50
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 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 Brazil,   Canada,   Croatia,   Denmark,   Former Serbia and Montenegro,   Hungary,   India,   Italy,   Mexico,   Poland,   Romania,   Russian Federation,   Sweden,   Ukraine,   United Kingdom,   United States
Removed Location Countries Serbia
Administrative Information
NCT Number  ICMJE NCT00124891
Other Study ID Numbers  ICMJE 3163K1-200
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical Monitor, MDWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor Brazil, [email protected]
Principal Investigator:Trial ManagerFor Poland, [email protected]
Principal Investigator:Trial ManagerFor Romania and Russia, [email protected]
Principal Investigator:Trial ManagerFor Mexico, [email protected]
Principal Investigator:Trial ManagerFor Italy, [email protected]
Principal Investigator:Trial ManagerFor Hungary, [email protected]
Principal Investigator:Trial ManagerFor United Kingdom, [email protected]
Principal Investigator:Trial ManagerFor Sweden and Denmark, [email protected]
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP