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

This study has been terminated.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00137332
First received: August 25, 2005
Last updated: December 6, 2007
Last verified: December 2007
  Purpose

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
Arrhythmia
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137332

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

No publications provided

ClinicalTrials.gov 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:
Arrhythmia
antiarrhythmic
programmed electrical stimulation

Additional relevant MeSH terms:
Coronary Artery Disease
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014