Clinical trial NCT00137332: Study Evaluating GAP-486 on Heart Rhythm in Patients With Coronary Artery Disease
Official title: A Study of the Effects GAP-486 on Ventricular Tachyarrhythmia Induction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Arrhythmia
Keywords: Arrhythmia
antiarrhythmic
programmed electrical stimulation
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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:
measure: 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.
Other outcomes:
Locations:
city: Sacramento
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Orlando
country: United States
state: Florida
city: Peoria
country: United States
state: Illinois
city: Iowa City
country: United States
state: Iowa
city: Worcester
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Lansing
country: United States
state: Michigan
city: Southfield
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Newark
country: United States
state: New Jersey
city: Winston-Salem
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Hershey
country: United States
state: Pennsylvania
city: Wynnewood
country: United States
state: Pennsylvania
city: Falls Church
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Victoria
country: Canada
state: British Columbia
city: St-Johnâ s
country: Canada
state: Newfoundland and Labrador
city: Halifax
country: Canada
state: Nova Scotia
city: London
country: Canada
state: Ontario
city: Newmarket
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Fleurimont
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Sainte-Foy
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: