Study Evaluating GAP-486 in Non-sustained Ventricular Tachycardia

NCT ID: NCT00124891

Last Updated: 2022-05-03

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

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-01

Study Completion Date

2006-11-01

Brief Summary

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To determine whether the administration of test article will decrease the occurrence of ventricular arrhythmias in patients who have acute coronary syndrome (unstable angina, ST segment elevated myocardial infarction or myocardial infarction without ST elevation).

Detailed Description

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Conditions

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Arrhythmias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Double-blind investigational anti-arrhythmic

Intervention Type DRUG

GAP-486

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female patients, 18 years of age or older, that have experienced an acute ischemic event within 24 hours prior to study entry.
* Patients with a documented history of coronary artery disease or left ventricular dysfunction
* Patients who have experienced an episode of non-sustained ventricular tachycardia within 24 hours of the index ischemic event

Exclusion Criteria

* Patients who have had percutaneous coronary intervention (PCI), thrombolytics, or open-heart surgery within 48 hours prior to study entry, or who require it during test article administration
* Patients who have taken another antiarrhythmic medication (other than a beta blocker) within 5 half-lives of the start of test article
* Patients who have a history of torsades de pointes, long QT syndrome, QTc \> 0.50
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

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor, MD

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Brazil, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Poland, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Romania and Russia, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Mexico, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Italy, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Hungary, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For United Kingdom, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Sweden and Denmark, [email protected]

Locations

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Merced, California, United States

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Melbourne, Florida, 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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Norfolk, Virginia, United States

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Curitiba, Paraná, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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São José, Rio Preto, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Salvador, , Brazil

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Calgary, Alberta, Canada

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Surrey, British Columbia, Canada

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Newmarket, Ontario, Canada

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Oshawa, Ontario, Canada

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Toronto, Ontario, 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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Montreal, Quebec, Canada

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Saint-Hyacinthe, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Terrebonne, Quebec, Canada

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Moose Jaw, Saskatchewan, Canada

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Multiple Locations, , Croatia

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Copenhagen, , Denmark

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Copenhagen South, , Denmark

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Frederiksberg, , Denmark

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Tószegi U. 21., H-5004 Szolnok, Hungary

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Nyíri U. 38., H-6000 Kecskemét, Hungary

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Markusovszky U. 3., H-9700 Szombathely, Hungary

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Seregélyesi, Székesfehérvár, Hungary

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Hyderabad, Andhra Pradesh, India

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Thellakom, Kottayam, India

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Bāndra, Mumbai, India

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Multiple Locations, New Delhi, India

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Rajasthan, Rajasthan, India

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Multiple Locations, , India

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Multiple Locations, Pisa, Italy

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Genova, , Italy

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Multiple Locations, , Italy

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Roma, , Italy

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México, D.F., Mexico

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Libertad, Guadalajara Jalisco, Mexico

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Multiple Locations, Guadalajara Jalisco, Mexico

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Zapopan, Guadalajara Jalisco, Mexico

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Monterrey, Nuevo León, Mexico

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Padilla, Veracruz, Mexico

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Tlalpan, , Mexico

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Ostrowiec Świętokrzyski, , Poland

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Piotrkow Trybunalski, , Poland

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Warsaw, , Poland

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Belgrade, , Serbia

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Kamenitz, , Serbia

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Gothenburg, , Sweden

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Kiev, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Odesa, , Ukraine

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Newcastle upon Tyne, , United Kingdom

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Nottingham, , United Kingdom

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Countries

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United States Brazil Canada Croatia Denmark Hungary India Italy Mexico Poland Romania Russia Serbia Sweden Ukraine United Kingdom

Other Identifiers

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3163K1-200

Identifier Type: -

Identifier Source: org_study_id

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