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Study Evaluating GAP-486 on Heart Rhythm in Patients With Coronary Artery Disease

Primary Purpose

Arrhythmia

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GAP-486 (ZP-123)
0.9% Sodium Chloride, USP
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arrhythmia focused on measuring Arrhythmia, antiarrhythmic, programmed electrical stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

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 Outcome Measures

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.

Full Information

First Posted
August 25, 2005
Last Updated
December 6, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00137332
Brief Title
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

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Terminated
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia
Keywords
Arrhythmia, antiarrhythmic, programmed electrical stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
90 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
GAP-486 (ZP-123)
Intervention Type
Drug
Intervention Name(s)
0.9% Sodium Chloride, USP
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61606
Country
United States
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 1H8
Country
Canada
City
St-Johnâ s
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 8C3
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1WB
Country
Canada
City
Fleurimont
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1CB
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
City
Sainte-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Study Evaluating GAP-486 on Heart Rhythm in Patients With Coronary Artery Disease

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