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

• ClinicalTrials.gov Identifier: NCT00137332
• Recruitment Status: Terminated
• First Posted: August 29, 2005
• Last Update Posted: December 10, 2007
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Information provided by: Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information

• First Submitted Date: August 25, 2005
• First Posted Date: August 29, 2005
• Last Update Posted Date: December 10, 2007
• Study Start Date: November 2005
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: August 25, 2005): The measure to determine the effect of the intervention will be whether abnormally fast heart rhythm can be induced after test drug is administered.
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: August 25, 2005): 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.
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study Evaluating GAP-486 on Heart Rhythm in Patients With Coronary Artery Disease
• Official Title: A Study of the Effects GAP-486 on Ventricular Tachyarrhythmia Induction
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Arrhythmia

Intervention

• Drug: GAP-486 (ZP-123)
• Drug: 0.9% Sodium Chloride, USP

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Enrollment (submitted: August 25, 2005): 90
• Original Enrollment: Same as current
• Actual Study Completion Date: October 2006
• Primary Completion Date: Not Provided

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT00137332
• Other Study ID Numbers: 3163K1-202
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Medical Monitor; Wyeth is now a wholly owned subsidiary of Pfizer

• PRS Account: Wyeth is now a wholly owned subsidiary of Pfizer
• Verification Date: December 2007