Study Evaluating GAP-486 in Heart Rhythm - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00137293

Purpose

The purpose of this study is to learn the effects of a test drug on heart rhythm, and to provide additional data to see if the test 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

Drug Information available for: Sodium chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Study to Characterize the Acute Electrophysiologic Properties, Safety and Tolerability of GAP-486

Further study details as provided by Wyeth:

Primary Outcome Measures:

This study takes place within 24 hours. The measure to determine the effect of the intervention will be the difference in values from the baseline electrophysiology study, and the values obtained after intervention within the test drug.

Secondary Outcome Measures:

This study takes place within 24 hours, and looks at the changes in values of electrophysiology studies, before and after administration of test article.

Estimated Enrollment:	30
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 undergoing an electrophysiology study for evaluation of heart rhythm.

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: NCT00137293

Locations

United States, California

San Francisco, California, United States, 94143
United States, District of Columbia

Washington, District of Columbia, United States, 20010
United States, Pennsylvania

Hershey, Pennsylvania, United States, 17033
Canada, Ontario

Toronto, Ontario, Canada, M5B 1W8

Ottawa, Ontario, Canada, K1Y 4W7
Canada, Quebec

Montreal, Quebec, Canada, H2L 4M1

Montreal, Quebec, Canada, H1T 1CB

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Study ID Numbers:	3163K1-201
Study First Received:	August 25, 2005
Last Updated:	December 6, 2007
ClinicalTrials.gov Identifier:	NCT00137293 History of Changes
Health Authority:	Canada: Health Canada; United States: Food and Drug Administration

Keywords provided by Wyeth:

Arrhythmia, syncope, antiarrhythmic

Study placed in the following topic categories:

Heart Diseases
Anti-Arrhythmia Agents
Syncope
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on May 07, 2009