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Study Evaluating GAP-486 in Non-Sustained Ventricular Tachycardia

Last updated on November 16, 2019

FOR MORE INFORMATION
Study Location
Merced, California, 95340 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Arrhythmias
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

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

- 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

NCT00124891
Pfizer
Terminated
Study Evaluating GAP-486 in Non-Sustained Ventricular Tachycardia

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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 SummaryTo 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 DescriptionNot 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: July 26, 2005)
500
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2006
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

INCLUSION CRITERIA:

  • 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

EXCLUSION CRITERIA:

  • 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 CountriesSerbia
 
Administrative Information
NCT Number  ICMJE NCT00124891
Other Study ID Numbers  ICMJE 3163K1-200
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot 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 AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateDecember 2007

ICMJE     Data element required by the

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

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