Study Evaluating GAP-486 in Heart Rhythm

Arrhythmia Clinical Trial

Official title:

A Study to Characterize the Acute Electrophysiologic Properties, Safety and Tolerability of GAP-486

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00137293
• Other study ID #: 3163K1-201
• 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 rhythm, and to provide additional data to see if the test drug is well tolerated and safe.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

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