Study Evaluating GAP-486 in Heart Rhythm

Phase 2

Terminated

• Conditions: Arrhythmia

• Registration Number: NCT00137293
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-08-25
• Study First Submitted QC: 2005-08-25
• Study First Posted: 2005-08-29
• Study Start: 2005-11
• Study Completion: 2006-10
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-06
• Last Update Posted: 2007-12-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

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