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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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9 May 2022 |
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Main ID: |
NCT00124891 |
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Date of registration:
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13/07/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study Evaluating GAP-486 in Non-sustained Ventricular Tachycardia
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Scientific title:
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Study Evaluating Subjects With Non-sustained Ventricular Tachycardia |
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Date of first enrolment:
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June 1, 2005 |
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Target sample size:
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500 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT00124891 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double.
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Phase:
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Phase 2
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Countries of recruitment
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Brazil
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Canada
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Croatia
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Denmark
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Former Serbia and Montenegro
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Hungary
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India
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Italy
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Mexico
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Poland
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Romania
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Russian Federation
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Serbia
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Sweden
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Brazil, xavierl@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Sweden and Denmark, MedInfoNord@wyeth.com |
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Name:
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Medical Monitor, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Hungary, WPBUMED@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Mexico, gomezlj@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Poland, WPWZMED@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For United Kingdom, ukmedinfo@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Italy, decresg@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Romania and Russia, WPVIMED@wyeth.com |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Arrhythmias
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Intervention(s)
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Drug: GAP-486
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Drug: Double-blind investigational anti-arrhythmic
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Primary Outcome(s)
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The total number of ventricular beats recorded by Holter monitoring during the 24 hr. on-therapy phase.
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Secondary Outcome(s)
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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.
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Secondary ID(s)
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3163K1-200
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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