Study Evaluating GAP-486 in Non-sustained Ventricular Tachycardia

Arrhythmias Clinical Trial

Official title:

Study Evaluating Subjects With Non-sustained Ventricular Tachycardia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00124891
• Other study ID #: 3163K1-200
• Status: Terminated
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Arrhythmias
• Arrhythmias, Cardiac
• Tachycardia
• Tachycardia, Ventricular

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.