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

This study has been terminated.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: August 25, 2005
Last updated: December 6, 2007
Last verified: December 2007

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.

Condition Intervention Phase
Drug: GAP-486 (ZP-123)
Drug: 0.9% Sodium Chloride, USP
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Study of the Effects GAP-486 on Ventricular Tachyarrhythmia Induction

Resource links provided by NLM:

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Estimated Enrollment: 90
Study Start Date: November 2005
Study Completion Date: October 2006

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00137332

  Show 33 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided Identifier: NCT00137332     History of Changes
Other Study ID Numbers: 3163K1-202
Study First Received: August 25, 2005
Last Updated: December 6, 2007
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
programmed electrical stimulation

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Tachycardia, Ventricular
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arterial Occlusive Diseases
Vascular Diseases
Tachycardia processed this record on April 20, 2014