Clinical trial NCT00124891: Study Evaluating GAP-486 in Non-sustained Ventricular Tachycardia
Official title: Study Evaluating Subjects With Non-sustained Ventricular Tachycardia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Arrhythmias
Keywords: Arrhythmias
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-07-28
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility criteria: 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

Primary outcomes:
measure: The total number of ventricular beats recorded by Holter monitoring during the 24 hr. on-therapy phase.
Secondary outcomes:
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.
Other outcomes:
Locations:
city: Merced
country: United States
state: California
city: Melbourne
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Peoria
country: United States
state: Illinois
city: Iowa City
country: United States
state: Iowa
city: Norfolk
country: United States
state: Virginia
city: Curitiba
country: Brazil
state: PR
city: Sao Jose
country: Brazil
state: Rio Preto
city: Porto Alegre
country: Brazil
state: RS
city: Porto Alegre
country: Brazil
state: RS
city: São Paulo
country: Brazil
state: SP
city: São Paulo
country: Brazil
state: SP
city: Salvador
country: Brazil
city: Calgary
country: Canada
state: Alberta
city: Surrey
country: Canada
state: British Columbia
city: Newmarket
country: Canada
state: Ontario
city: Oshawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montréal
country: Canada
state: Quebec
city: Montréal
country: Canada
state: Quebec
city: Montréal
country: Canada
state: Quebec
city: Montréal
country: Canada
state: Quebec
city: Saint-Hyacinthe
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: Terrebonne
country: Canada
state: Quebec
city: Moose Jaw
country: Canada
state: Saskatchewan
city: Multiple Locations
country: Croatia
city: Copenhagen South
country: Denmark
city: Copenhagen
country: Denmark
city: Frederiksberg
country: Denmark
city: Tószegi U. 21.
country: Hungary
state: H-5004 Szolnok
city: Nyíri U. 38.
country: Hungary
state: H-6000 Kecskemét
city: Markusovszky U. 3.
country: Hungary
state: H-9700 Szombathely
city: Seregélyesi
country: Hungary
state: Székesfehérvár
city: Hyderabad
country: India
state: Andhra Pradesh
city: Thellakom
country: India
state: Kottayam
city: Bandra
country: India
state: Mumbai
city: Multiple Locations
country: India
state: New Delhi
city: Multiple Locations
country: India
city: Rajasthan
country: India
city: Multiple Locations
country: Italy
state: Pisa
city: Genova
country: Italy
city: Multiple Locations
country: Italy
city: Roma
country: Italy
city: México
country: Mexico
state: D.f.
city: Libertad
country: Mexico
state: Guadalajara Jalisco
city: Multiple Locations
country: Mexico
state: Guadalajara Jalisco
city: Zapopan
country: Mexico
state: Guadalajara Jalisco
city: Monterrey
country: Mexico
state: Nuevo Leon
city: Padilla
country: Mexico
state: Veracruz
city: Tlalpan
country: Mexico
city: Ostrowiec Swietokrzyski
country: Poland
city: Piotrkow Trybunalski
country: Poland
city: Warszawa
country: Poland
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Belgrade
country: Serbia
city: Sremska Kamenica
country: Serbia
city: Göteborg
country: Sweden
city: Kiev
country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Odessa
country: Ukraine
city: Newcastle upon Tyne
country: United Kingdom
city: Nottingham
country: United Kingdom
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
affiliation: For Brazil, xavierl@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Poland, WPWZMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Romania and Russia, WPVIMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Mexico, gomezlj@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Italy, decresg@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Hungary, WPBUMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For United Kingdom, ukmedinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Sweden and Denmark, MedInfoNord@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References: