Study Evaluating GAP-486 in Heart Rhythm

This study has been terminated.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00137293
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 rhythm, and to provide additional data to see if the test 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
Official Title: A Study to Characterize the Acute Electrophysiologic Properties, Safety and Tolerability of GAP-486

Resource links provided by NLM:


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

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

Estimated Enrollment: 30
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 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
  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: NCT00137293

Locations
United States, California
San Francisco, California, United States, 94143
United States, District of Columbia
Washington, District of Columbia, United States, 20010
United States, Pennsylvania
Hershey, Pennsylvania, United States, 17033
Canada, Ontario
Ottawa, Ontario, Canada, K1Y 4W7
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Montreal, Quebec, Canada, H2L 4M1
Montreal, Quebec, Canada, H1T 1CB
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: NCT00137293     History of Changes
Other Study ID Numbers: 3163K1-201
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, syncope, antiarrhythmic

ClinicalTrials.gov processed this record on October 30, 2014