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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00137332
Recruitment Status : Terminated
First Posted : August 29, 2005
Last Update Posted : December 10, 2007
Sponsor:
Information provided by:
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 rhythms, which may become life-threatening if left untreated, and to provide data to see if the drug is well tolerated and safe.

Condition or disease Intervention/treatment Phase
Arrhythmia Drug: GAP-486 (ZP-123) Drug: 0.9% Sodium Chloride, USP Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Study of the Effects GAP-486 on Ventricular Tachyarrhythmia Induction
Study Start Date : November 2005
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 :
  1. 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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00137332


Locations
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United States, California
Sacramento, California, United States, 95819
San Francisco, California, United States, 94143
United States, District of Columbia
Washington, District of Columbia, United States, 20010
United States, Florida
Orlando, Florida, United States, 32803
United States, Illinois
Peoria, Illinois, United States, 61606
United States, Iowa
Iowa City, Iowa, United States, 52242
United States, Massachusetts
Worcester, Massachusetts, United States, 01655
United States, Michigan
Ann Arbor, Michigan, United States, 48109
Lansing, Michigan, United States, 48910
Southfield, Michigan, United States, 48075
United States, Minnesota
Minneapolis, Minnesota, United States, 55407
United States, New Jersey
Newark, New Jersey, United States, 07112
United States, North Carolina
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Cleveland, Ohio, United States, 44109
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Hershey, Pennsylvania, United States, 17033
Wynnewood, Pennsylvania, United States, 19096
United States, Virginia
Falls Church, Virginia, United States, 22042
Norfolk, Virginia, United States, 23507
Canada, Alberta
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Vancouver, British Columbia, Canada, V6Z 1Y6
Victoria, British Columbia, Canada, V8R 1H8
Canada, Newfoundland and Labrador
St-Johnâ s, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
London, Ontario, Canada, N6A 5A5
Newmarket, Ontario, Canada, L3Y 8C3
Toronto, Ontario, Canada, M5B 1WB
Canada, Quebec
Fleurimont, Quebec, Canada, J1H 5N4
Montreal, Quebec, Canada, H1T 1CB
Montreal, Quebec, Canada, H2L 4M1
Montreal, Quebec, Canada, H4J 1C5
Sainte-Foy, Quebec, Canada, G1V 4G5
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
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ClinicalTrials.gov Identifier: NCT00137332    
Other Study ID Numbers: 3163K1-202
First Posted: August 29, 2005    Key Record Dates
Last Update Posted: December 10, 2007
Last Verified: December 2007
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Arrhythmia
antiarrhythmic
programmed electrical stimulation
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes