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

NCT ID: NCT00137332

Last Updated: 2007-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-10-31

Brief Summary

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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

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Conditions

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Arrhythmia

Keywords

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Arrhythmia antiarrhythmic programmed electrical stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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GAP-486 (ZP-123)

Intervention Type DRUG

0.9% Sodium Chloride, USP

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Sacramento, California, United States

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San Francisco, California, United States

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Washington D.C., District of Columbia, United States

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Orlando, Florida, United States

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Peoria, Illinois, United States

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Iowa City, Iowa, United States

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Worcester, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Lansing, Michigan, United States

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Southfield, Michigan, United States

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Minneapolis, Minnesota, United States

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Newark, New Jersey, United States

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Winston-Salem, North Carolina, United States

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Cleveland, Ohio, United States

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Cleveland, Ohio, United States

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Hershey, Pennsylvania, United States

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Wynnewood, Pennsylvania, United States

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Falls Church, Virginia, United States

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Norfolk, Virginia, United States

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Edmonton, Alberta, Canada

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Vancouver, British Columbia, Canada

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Victoria, British Columbia, Canada

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St-Johnâ S, Newfoundland and Labrador, Canada

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Halifax, Nova Scotia, Canada

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London, Ontario, Canada

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Newmarket, Ontario, Canada

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Toronto, Ontario, Canada

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Fleurimont, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Sainte-Foy, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Countries

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United States Canada

Other Identifiers

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3163K1-202

Identifier Type: -

Identifier Source: org_study_id