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

Arrhythmia Clinical Trial

Official title:

A Study of the Effects GAP-486 on Ventricular Tachyarrhythmia Induction

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00137332
• Other study ID #: 3163K1-202
• Status: Terminated
• Phase: Phase 2
• First received: August 25, 2005
• Last updated: December 6, 2007
• Start date: November 2005
• Est. completion date: October 2006

Study information

• Verified date: December 2007
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 90
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arrhythmia

Intervention

Drug:
• GAP-486 (ZP-123)

• 0.9% Sodium Chloride, USP

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,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.