Study Evaluating GAP-486 in Non-sustained Ventricular Tachycardia

April 28, 2022 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

Study Evaluating Subjects With Non-sustained Ventricular Tachycardia

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

500

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Salvador, Brazil, 41256-900
    • PR
      • Curitiba, PR, Brazil
    • RS
      • Porto Alegre, RS, Brazil
      • Porto Alegre, RS, Brazil, 790620-000
    • Rio Preto
      • Sao Jose, Rio Preto, Brazil, 15090-000
    • SP
      • São Paulo, SP, Brazil, 04822-320
      • São Paulo, SP, Brazil
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2V 1P9
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 1Z2
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 8C3
      • Oshawa, Ontario, Canada, L1J 2J9
      • Toronto, Ontario, Canada, M5B 1W6
    • Quebec
      • Montréal, Quebec, Canada, H1T 1C8
      • Montréal, Quebec, Canada, H1T 2M4
      • Montréal, Quebec, Canada, H2L 4M1
      • Montréal, Quebec, Canada, H2W 1T8
      • Saint-Hyacinthe, Quebec, Canada, J2S 4Y8
      • Sherbrooke, Quebec, Canada, J1H 5N4
      • Terrebonne, Quebec, Canada, J6V 2H2
    • Saskatchewan
      • Moose Jaw, Saskatchewan, Canada, S6H 0W2
  • Croatia
      • Multiple Locations, Croatia
  • Denmark
      • Copenhagen, Denmark, 2400
      • Copenhagen South, Denmark, 2300
      • Frederiksberg, Denmark, 2000
  • Hungary
    • H-5004 Szolnok
      • Tószegi U. 21., H-5004 Szolnok, Hungary
    • H-6000 Kecskemét
      • Nyíri U. 38., H-6000 Kecskemét, Hungary
    • H-9700 Szombathely
      • Markusovszky U. 3., H-9700 Szombathely, Hungary
    • Székesfehérvár
      • Seregélyesi, Székesfehérvár, Hungary, 8000
  • India
      • Multiple Locations, India
      • Rajasthan, India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500 034
    • Kottayam
      • Thellakom, Kottayam, India
    • Mumbai
      • Bandra, Mumbai, India
    • New Delhi
      • Multiple Locations, New Delhi, India
  • Italy
      • Genova, Italy
      • Multiple Locations, Italy
      • Roma, Italy, 00168
    • Pisa
      • Multiple Locations, Pisa, Italy
  • Mexico
      • Tlalpan, Mexico, 14080
    • D.f.
      • México, D.f., Mexico, 07660
    • Guadalajara Jalisco
      • Libertad, Guadalajara Jalisco, Mexico, 4360
      • Multiple Locations, Guadalajara Jalisco, Mexico, 44340
      • Zapopan, Guadalajara Jalisco, Mexico, 45150
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
    • Veracruz
      • Padilla, Veracruz, Mexico, 91897
  • Poland
      • Ostrowiec Swietokrzyski, Poland, 27-400
      • Piotrkow Trybunalski, Poland
      • Warszawa, Poland, 01-211
  • Romania
      • Bucuresti, Romania, 041914
      • Bucuresti, Romania, 014461
      • Bucuresti, Romania, 021659
      • Bucuresti, Romania, 050098
      • Bucuresti, Romania, 7000
  • Russian Federation
      • Moscow, Russian Federation
      • Moscow, Russian Federation, 121309
      • Moscow, Russian Federation, 129336
      • Saint Petersburg, Russian Federation
      • Saint Petersburg, Russian Federation, 191187
      • Saint Petersburg, Russian Federation, 195067
      • Saint Petersburg, Russian Federation, 197242
  • Serbia
      • Belgrade, Serbia, 11000
      • Sremska Kamenica, Serbia, 21204
  • Sweden
      • Göteborg, Sweden, 41345
  • Ukraine
      • Kiev, Ukraine, 01151
      • Kyiv, Ukraine, 02660
      • Kyiv, Ukraine, 02091
      • Odessa, Ukraine, 65014
  • United Kingdom
      • Newcastle upon Tyne, United Kingdom
      • Nottingham, United Kingdom, NG7 2UH
  • United States
    • California
      • Merced, California, United States, 95340
    • Florida
      • Melbourne, Florida, United States, 32901
      • Orlando, Florida, United States, 32803
    • Illinois
      • Peoria, Illinois, United States, 61606
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Virginia
      • Norfolk, Virginia, United States, 23507

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

  • Principal Investigator: Trial Manager, For Poland, WPWZMED@wyeth.com
  • Principal Investigator: Trial Manager, For Brazil, xavierl@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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2005

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

July 13, 2005

First Submitted That Met QC Criteria

July 26, 2005

First Posted (Estimate)

July 28, 2005

Study Record Updates

Last Update Posted (Actual)

May 3, 2022

Last Update Submitted That Met QC Criteria

April 28, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3163K1-200

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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