Study Evaluating GAP-486 on Heart Rhythm in Patients With Coronary Artery Disease
A Study of the Effects GAP-486 on Ventricular Tachyarrhythmia Induction
1 other identifier
interventional
90
2 countries
33
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2005
Shorter than P25 for phase_2
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2005
CompletedFirst Posted
Study publicly available on registry
August 29, 2005
CompletedStudy Start
First participant enrolled
November 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedDecember 10, 2007
December 1, 2007
August 25, 2005
December 6, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (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 Outcomes (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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients with uncontrolled blood pressure
- Patients with certain cardiac risk factors
- Patients with significant kidney or liver problems
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Unknown Facility
Sacramento, California, 95819, United States
Unknown Facility
San Francisco, California, 94143, United States
Unknown Facility
Washington D.C., District of Columbia, 20010, United States
Unknown Facility
Orlando, Florida, 32803, United States
Unknown Facility
Peoria, Illinois, 61606, United States
Unknown Facility
Iowa City, Iowa, 52242, United States
Unknown Facility
Worcester, Massachusetts, 01655, United States
Unknown Facility
Ann Arbor, Michigan, 48109, United States
Unknown Facility
Lansing, Michigan, 48910, United States
Unknown Facility
Southfield, Michigan, 48075, United States
Unknown Facility
Minneapolis, Minnesota, 55407, United States
Unknown Facility
Newark, New Jersey, 07112, United States
Unknown Facility
Winston-Salem, North Carolina, 27157, United States
Unknown Facility
Cleveland, Ohio, 44109, United States
Unknown Facility
Cleveland, Ohio, 44195, United States
Unknown Facility
Hershey, Pennsylvania, 17033, United States
Unknown Facility
Wynnewood, Pennsylvania, 19096, United States
Unknown Facility
Falls Church, Virginia, 22042, United States
Unknown Facility
Norfolk, Virginia, 23507, United States
Unknown Facility
Edmonton, Alberta, T6G 2B7, Canada
Unknown Facility
Vancouver, British Columbia, V6Z 1Y6, Canada
Unknown Facility
Victoria, British Columbia, V8R 1H8, Canada
Unknown Facility
St-Johnâ S, Newfoundland and Labrador, A1B 3V6, Canada
Unknown Facility
Halifax, Nova Scotia, B3H 3A7, Canada
Unknown Facility
London, Ontario, N6A 5A5, Canada
Unknown Facility
Newmarket, Ontario, L3Y 8C3, Canada
Unknown Facility
Toronto, Ontario, M5B 1WB, Canada
Unknown Facility
Fleurimont, Quebec, J1H 5N4, Canada
Unknown Facility
Montreal, Quebec, H1T 1CB, Canada
Unknown Facility
Montreal, Quebec, H2L 4M1, Canada
Unknown Facility
Montreal, Quebec, H4J 1C5, Canada
Unknown Facility
Sainte-Foy, Quebec, G1V 4G5, Canada
Unknown Facility
Sherbrooke, Quebec, J1H 5N4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 25, 2005
First Posted
August 29, 2005
Study Start
November 1, 2005
Study Completion
October 1, 2006
Last Updated
December 10, 2007
Record last verified: 2007-12