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Study Evaluating GAP-486 in Heart Rhythm

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: NCT00137293
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

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: A Study to Characterize the Acute Electrophysiologic Properties, Safety and Tolerability of GAP-486
Study Start Date : November 2005
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. This study takes place within 24 hours, and looks at the changes in values of electrophysiology studies, before and after administration of test article.

Eligibility Criteria
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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 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
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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): NCT00137293


Locations
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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, H1T 1CB
Montreal, Quebec, Canada, H2L 4M1
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
More Information
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ClinicalTrials.gov Identifier: NCT00137293    
Other Study ID Numbers: 3163K1-201
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, syncope, antiarrhythmic
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes