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Study Evaluating GAP-486 in Heart Rhythm - Article


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Potassium Chloride Effervescent

Effer-K; Effervescent Potassium; Gen-K Powder; K+ Care; K-Lor Powder; K-Lyte; K-Lyte/Cl; Kay Ciel Powder; Klor-Con/EF; Klorvess 




Clinical Trial: Study Evaluating GAP-486 in Heart Rhythm

This study is not yet open for patient recruitment.
Verified by Wyeth August 2005

Sponsored by: Wyeth
Information provided by: Wyeth
ClinicalTrials.gov Identifier: NCT00137293

Purpose

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

MedlinePlus related topics:  Arrhythmia

Study Type: Interventional
Study Design: Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: A Study to Characterize the Acute Electrophysiologic Properties, Safety and Tolerability of GAP-486

Further Study Details: 
Primary Outcomes: 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 Outcomes: This study takes place within 24 hours, and looks at the changes in values of Electrophysiology studies, before and after administration of test article.
Expected Total Enrollment:  30

Study start: August 2005

Eligibility

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00137293

Trial Manager       clinicaltrialinfo@wyeth.com

California
      San Francisco,  California,  94143,  United States
  see Central Contact 

District of Columbia
      Washington,  District of Columbia,  20010,  United States
  see Central Contact 

Pennsylvania
      Hershey,  Pennsylvania,  17033,  United States
  see Central Contact 

Canada, Ontario
      Toronto,  Ontario,  M5B 1W8,  Canada
  see Central Contact 

      Ottawa,  Ontario,  K1Y 4W7,  Canada
  see Central Contact 

Canada, Quebec
      Montreal,  Quebec,  H2L 4M1,  Canada
  see Central Contact 

      Montreal,  Quebec,  H1T 1CB,  Canada
  see Central Contact 

Study chairs or principal investigators

Medical Monitor,  Study Director,  Wyeth Research   

More Information

Study ID Numbers:  3163K1-201
Last Updated:  August 26, 2005
Record first received:  August 25, 2005
ClinicalTrials.gov Identifier:  NCT00137293
Health Authority: United States: Food and Drug Administration; Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-08-30

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Page Updated: June 1, 2005
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