Study Evaluating GAP-486 on Heart Rhythm in Patients With Coronary Artery Disease - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00137332

Purpose

The purpose of this study is to learn the effects of a test drug on heart rhythms, which may become life-threatening if left untreated, and to provide data to see if the drug is well tolerated and safe.

Condition	Intervention	Phase
Arrhythmia	Drug: GAP-486 (ZP-123) Drug: 0.9% Sodium Chloride, USP	Phase II

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Arrhythmia Coronary Artery Disease

Drug Information available for: Sodium chloride Chlorides

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Study of the Effects GAP-486 on Ventricular Tachyarrhythmia Induction

Further study details as provided by Wyeth:

Primary Outcome Measures:

The measure to determine the effect of the intervention will be whether abnormally fast heart rhythm can be induced after test drug is administered.

Secondary Outcome Measures:

This study takes place within 24 hours, and looks at whether the test article makes a difference in inducing the abnormally fast heart rhythm during a 24 hour observational period.

Estimated Enrollment:	90
Study Start Date:	November 2005
Study Completion Date:	October 2006

Eligibility

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

Criteria

Inclusion Criteria:

Patients with or without ICDs (implantable cardioverter defibrillators)
Patients undergoing an electrophysiology study for evaluation of ventricular rhythm
Patients with a history of heart disease

Exclusion Criteria:

Patients with uncontrolled blood pressure
Patients with certain cardiac risk factors
Patients with significant kidney or liver problems

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137332

Show 33 Study Locations

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Study ID Numbers:	3163K1-202
Study First Received:	August 25, 2005
Last Updated:	December 6, 2007
ClinicalTrials.gov Identifier:	NCT00137332
Health Authority:	Canada: Health Canada; United States: Food and Drug Administration

Keywords provided by Wyeth:

Arrhythmia
antiarrhythmic
programmed electrical stimulation

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Arteriosclerosis
Ischemia
Tachycardia, Ventricular
Coronary Artery Disease
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009