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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

Tracking Information
First Submitted Date  ICMJE August 25, 2005
First Posted Date  ICMJE August 29, 2005
Last Update Posted Date December 10, 2007
Study Start Date  ICMJE November 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2005)
The measure to determine the effect of the intervention will be whether abnormally fast heart rhythm can be induced after test drug is administered.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2005)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating GAP-486 on Heart Rhythm in Patients With Coronary Artery Disease
Official Title  ICMJE A Study of the Effects GAP-486 on Ventricular Tachyarrhythmia Induction
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Arrhythmia
Intervention  ICMJE
  • Drug: GAP-486 (ZP-123)
  • Drug: 0.9% Sodium Chloride, USP
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: August 25, 2005)
90
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00137332
Other Study ID Numbers  ICMJE 3163K1-202
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP