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Trial record 1 of 1 for:    NCT00124891
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Study Evaluating GAP-486 in Non-Sustained Ventricular Tachycardia

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ClinicalTrials.gov Identifier: NCT00124891
Recruitment Status : Terminated
First Posted : July 28, 2005
Last Update Posted : December 10, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE July 13, 2005
First Posted Date  ICMJE July 28, 2005
Last Update Posted Date December 10, 2007
Study Start Date  ICMJE June 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 20, 2005)
The total number of ventricular beats recorded by Holter monitoring during the 24 hr. on-therapy phase.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00124891 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2005)
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 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 Date Not 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 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, 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
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007

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