Study Evaluating GAP-486 in Non-Sustained Ventricular Tachycardia - Full Text View

Purpose

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).

Condition	Intervention	Phase
Arrhythmias	Drug: Double-blind investigational anti-arrhythmic Drug: GAP-486	Phase II

Genetics Home Reference related topics:

Brugada syndrome short QT syndrome

MedlinePlus related topics:

Arrhythmia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Study Evaluating Subjects With Non-Sustained Ventricular Tachycardia

Further study details as provided by Wyeth:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Estimated Enrollment:	500
Study Start Date:	June 2005
Study Completion Date:	November 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124891

Show 77 Study Locations

Sponsors and Collaborators

Wyeth

Investigators


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

More Information

Study ID Numbers:	3163K1-200
First Received:	July 13, 2005
Last Updated:	December 6, 2007
ClinicalTrials.gov Identifier:	NCT00124891
Health Authority:	United States: Food and Drug Administration; European Union: European Medicines Agency

Keywords provided by Wyeth:

Arrhythmias

Study placed in the following topic categories:

Heart Diseases

Tachycardia

Tachycardia, Ventricular

Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes

Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 04, 2008

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00124891