Study Evaluating GAP-486 in Non-Sustained Ventricular Tachycardia - Tabular View

Tracking Information

First Received Date ^ICMJE

July 13, 2005

Last Updated Date

December 6, 2007

Start Date ^ICMJE

June 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

The total number of ventricular beats recorded by Holter monitoring during the 24 hr. on-therapy phase.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00124891 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Same as current

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Arrhythmias

Intervention ^ICMJE

Drug: Double-blind investigational anti-arrhythmic
Drug: GAP-486

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

500

Completion Date

November 2006

Primary Completion Date

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

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

Administrative Information

NCT ID ^ICMJE

NCT00124891

Responsible Party

Study ID Numbers ^ICMJE

3163K1-200

Study Sponsor ^ICMJE

Wyeth

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:	Medical Monitor, MD	Wyeth
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

Information Provided By

Wyeth

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP