Study Evaluating GAP-486 in Non-sustained Ventricular Tachycardia

NCT00124891 | Terminated Phase 2

• 1 other identifier: 3163K1-200
• Study Type: interventional
• Target: 500
• Locations: 15 countries
• Sites: 73

Brief Summary

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).

Conditions

Arrhythmias

Keywords

Arrhythmias

Outcome Measures

Primary Outcomes (1)

• The total number of ventricular beats recorded by Holter monitoring during the 24 hr. on-therapy phase.

Secondary Outcomes (1)

• The total number of NSVT beats, PVCs/couplets, NSVT episodes during the 24 hr. on-therapy phase and incidence of new-onset atrial fibrillation during the 24hr. on-therapy phase.

Interventions

Double-blind investigational anti-arrhythmic DRUG

GAP-486 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (75)

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Merced, California, 95340, United States

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Melbourne, Florida, 32901, United States

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Orlando, Florida, 32803, United States

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Peoria, Illinois, 61606, United States

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Iowa City, Iowa, 52242, United States

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Norfolk, Virginia, 23507, United States

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Curitiba, Paraná, Brazil

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Porto Alegre, Rio Grande do Sul, 790620-000, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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São José, Rio Preto, 15090-000, Brazil

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São Paulo, São Paulo, 04822-320, Brazil

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São Paulo, São Paulo, Brazil

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Salvador, 41256-900, Brazil

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Calgary, Alberta, T2V 1P9, Canada

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Surrey, British Columbia, V3V 1Z2, Canada

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Newmarket, Ontario, L3Y 8C3, Canada

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Oshawa, Ontario, L1J 2J9, Canada

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Toronto, Ontario, M5B 1W6, Canada

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Montreal, Quebec, H1T 1C8, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Montreal, Quebec, H2L 4M1, Canada

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Montreal, Quebec, H2W 1T8, Canada

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Saint-Hyacinthe, Quebec, J2S 4Y8, Canada

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Sherbrooke, Quebec, J1H 5N4, Canada

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Terrebonne, Quebec, J6V 2H2, Canada

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Moose Jaw, Saskatchewan, S6H 0W2, Canada

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Multiple Locations, Croatia

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Copenhagen, 2400, Denmark

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Copenhagen South, 2300, Denmark

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Frederiksberg, 2000, 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, 8000, Hungary

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Hyderabad, Andhra Pradesh, 500 034, India

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Thellakom, Kottayam, India

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Bandra, 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, 00168, Italy

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México, D.F., 07660, Mexico

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Libertad, Guadalajara Jalisco, 4360, Mexico

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Multiple Locations, Guadalajara Jalisco, 44340, Mexico

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Zapopan, Guadalajara Jalisco, 45150, Mexico

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Monterrey, Nuevo León, 64460, Mexico

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Padilla, Veracruz, 91897, Mexico

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Tlalpan, 14080, Mexico

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Ostrowiec Świętokrzyski, 27-400, Poland

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Piotrkow Trybunalski, Poland

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Warsaw, 01-211, Poland

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Bucharest, 014461, Romania

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Bucharest, 021659, Romania

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Bucharest, 041914, Romania

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Bucharest, 050098, Romania

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Bucharest, 7000, Romania

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Moscow, 121309, Russia

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Moscow, 129336, Russia

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Moscow, Russia

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Saint Petersburg, 191187, Russia

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Saint Petersburg, 195067, Russia

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Saint Petersburg, 197242, Russia

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Saint Petersburg, Russia

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Belgrade, 11000, Serbia

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Kamenitz, 21204, Serbia

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Gothenburg, 41345, Sweden

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Kiev, 01151, Ukraine

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Kyiv, 02091, Ukraine

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Kyiv, 02660, Ukraine

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Odesa, 65014, Ukraine

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Newcastle upon Tyne, United Kingdom

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Nottingham, NG7 2UH, United Kingdom

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MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Medical Monitor, MD

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

• Trial Manager

  For Brazil, xavierl@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Poland, WPWZMED@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Romania and Russia, WPVIMED@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Mexico, gomezlj@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Italy, decresg@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Hungary, WPBUMED@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For United Kingdom, ukmedinfo@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Sweden and Denmark, MedInfoNord@wyeth.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2005
• First Posted: July 28, 2005
• Study Start: June 1, 2005
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: May 3, 2022

Record last verified: 2022-04

Locations

BR (7); GB (2); DK (3); CA (13); HU (4); ME (7); IN (6); SE (1); RO (5); US (6); IT (4); RU (7); UA (4); PL (3); CR (1)