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Study Evaluating GAP-486 in Non-Sustained Ventricular Tachycardia

This study has been terminated.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00124891
First received: July 13, 2005
Last updated: December 6, 2007
Last verified: December 2007
History of Changes
  Purpose

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).


Condition Intervention Phase
Arrhythmias
 Drug: Double-blind investigational anti-arrhythmic
Drug: GAP-486
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Study Evaluating Subjects With Non-Sustained Ventricular Tachycardia

Resource links provided by NLM:

MedlinePlus related topics: Arrhythmia
U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • The total number of ventricular beats recorded by Holter monitoring during the 24 hr. on-therapy phase.

Secondary Outcome Measures:
  • The total number of NSVT beats, PVCs/couplets, NSVT episodes during the 24 hr. on-therapy phase and incidence of new-onset atrial fibrillation during the 24hr. on-therapy phase.

Estimated Enrollment: 500
Study Start Date: June 2005
Study Completion Date: November 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00124891

  Show 76 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Brazil, xavierl@wyeth.com
Principal Investigator: Trial Manager For Poland, WPWZMED@wyeth.com
Principal Investigator: Trial Manager For Romania and Russia, WPVIMED@wyeth.com
Principal Investigator: Trial Manager For Mexico, gomezlj@wyeth.com
Principal Investigator: Trial Manager For Italy, decresg@wyeth.com
Principal Investigator: Trial Manager For Hungary, WPBUMED@wyeth.com
Principal Investigator: Trial Manager For United Kingdom, ukmedinfo@wyeth.com
Principal Investigator: Trial Manager For Sweden and Denmark, MedInfoNord@wyeth.com
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00124891     History of Changes
Other Study ID Numbers: 3163K1-200
Study First Received: July 13, 2005
Last Updated: December 6, 2007
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Arrhythmias

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Tachycardia
Tachycardia, Ventricular
Heart Diseases
Cardiovascular Diseases
 Pathologic Processes
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013