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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00124891
Other study ID # 3163K1-200
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date June 1, 2005
Est. completion date November 1, 2006

Study information

Verified date April 2022
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Terminated
Enrollment 500
Est. completion date November 1, 2006
Est. primary completion date November 1, 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Double-blind investigational anti-arrhythmic

GAP-486


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  Croatia,  Denmark,  Hungary,  India,  Italy,  Mexico,  Poland,  Romania,  Russian Federation,  Serbia,  Sweden,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary The total number of ventricular beats recorded by Holter monitoring during the 24 hr. on-therapy phase.
Secondary 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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