The purpose of this study is to learn the effects of 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 II

Further Study Details: 

Primary Outcomes: 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 Outcomes: 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.
Expected Total Enrollment:  90

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• patients with or without ICDs (implantable cardioverter defibrillator)
• 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00137332

Trial Manager       clinicaltrialinfo@wyeth.com

California
      San Francisco,  California,  94143,  United States
      Sacramento,  California,  95819,  United States
District of Columbia
      Washington,  District of Columbia,  20010,  United States
Illinois
      Peoria,  Illinois,  61606,  United States
Iowa
      Iowa City,  Iowa,  52242,  United States
Michigan
      Southfield,  Michigan,  48075,  United States
Minnesota
      Minneapolis,  Minnesota,  55407,  United States
North Carolina
      Winston Salem,  North Carolina,  27157,  United States
Ohio
      Cleveland,  Ohio,  44109,  United States
      Cleveland,  Ohio,  44195,  United States
Pennsylvania
      Hershey,  Pennsylvania,  17033,  United States
      Wynnewood,  Pennsylvania,  19096,  United States
Virginia
      Falls Church,  Virginia,  22042,  United States
      Norfolk,  Virginia,  23507,  United States
Canada, Alberta
      Calgary,  Alberta,  T2N 2T9,  Canada
      Edmonton,  Alberta,  T6G 2B7,  Canada
      Calgary,  Alberta,  T2N 2T9,  Canada
Canada, British Columbia
      Vancouver,  British Columbia,  V6Z 1Y6,  Canada
      Victoria,  British Columbia,  V8R 1H8,  Canada
Canada, Newfoundland and Labrador
      St-John’s,  Newfoundland and Labrador,  A1B 3V6,  Canada
Canada, Nova Scotia
      Halifax,  Nova Scotia,  B3H 3E7,  Canada
Canada, Ontario
      Toronto,  Ontario,  M5B 1W8,  Canada
      Ottawa,  Ontario,  K1Y 4W7,  Canada
      Hamilton,  Ontario,  L8L 2X2,  Canada
      Newmarket,  Ontario,  L3Y 2P9,  Canada
      London,  Ontario,  N6A 5A5,  Canada
Canada, Quebec
      Montreal,  Quebec,  H2L 4M1,  Canada
      Montreal,  Quebec,  H1T 1CB,  Canada
      St-Foy,  Quebec,  G1V 4G5,  Canada
      Montreal,  Quebec,  H4J 1C5,  Canada

Study chairs or principal investigators

Medical Monitor,  Study Director,  Wyeth Research   

Study ID Numbers:  3163K1-202
Last Updated:  August 26, 2005
Record first received:  August 25, 2005
ClinicalTrials.gov Identifier:  NCT00137332
Health Authority: United States: Food and Drug Administration; Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-08-30