AzTrials
AzTrials

ArrhythmiasPhase 2NCT00124891

Study Evaluating GAP-486 in Non-sustained Ventricular Tachycardia

A Phase 2 study testing Double-blind investigational anti-arrhythmic and GAP-486 in people with Arrhythmias, run by Wyeth is now a wholly owned subsidiary of Pfizer at 75 sites in 16 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arrhythmias
What is being tested?
Double-blind investigational anti-arrhythmic and GAP-486
How many people
500 participants
Where
75 sitesin 16 countries
Study dates
1 Jun 2005to 1 Nov 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

75 sites in 16 countries.

75 sites in 16 countries

Canada13 sites

  • Study site

    Calgary, Alberta, T2V 1P9

  • Study site

    Montreal, Quebec, H1T 1C8

  • Study site

    Montreal, Quebec, H1T 2M4

  • Study site

    Montreal, Quebec, H2L 4M1

  • Study site

    Montreal, Quebec, H2W 1T8

  • Study site

    Moose Jaw, Saskatchewan, S6H 0W2

  • Study site

    Newmarket, Ontario, L3Y 8C3

  • Study site

    Oshawa, Ontario, L1J 2J9

  • Study site

    Saint-Hyacinthe, Quebec, J2S 4Y8

  • Study site

    Sherbrooke, Quebec, J1H 5N4

  • Study site

    Surrey, British Columbia, V3V 1Z2

  • Study site

    Terrebonne, Quebec, J6V 2H2

  • Study site

    Toronto, Ontario, M5B 1W6

Other trials in Canada

Brazil7 sites

  • Study site

    Curitiba, Paraná

  • Study site

    Porto Alegre, Rio Grande do Sul, 790620-000

  • Study site

    Porto Alegre, Rio Grande do Sul

  • Study site

    Salvador, 41256-900

  • Study site

    São José, Rio Preto, 15090-000

  • Study site

    São Paulo, São Paulo, 04822-320

  • Study site

    São Paulo, São Paulo

Other trials in Brazil

Mexico7 sites

  • Study site

    Libertad, Guadalajara Jalisco, 4360

  • Study site

    México, D.F., 07660

  • Study site

    Monterrey, Nuevo León, 64460

  • Study site

    Multiple Locations, Guadalajara Jalisco, 44340

  • Study site

    Padilla, Veracruz, 91897

  • Study site

    Tlalpan, 14080

  • Study site

    Zapopan, Guadalajara Jalisco, 45150

Other trials in Mexico

Russia7 sites

  • Study site

    Moscow, 121309

  • Study site

    Moscow, 129336

  • Study site

    Moscow

  • Study site

    Saint Petersburg, 191187

  • Study site

    Saint Petersburg, 195067

  • Study site

    Saint Petersburg, 197242

  • Study site

    Saint Petersburg

Other trials in Russia

United States6 sites

  • Study site

    Iowa City, Iowa, 52242

  • Study site

    Melbourne, Florida, 32901

  • Study site

    Merced, California, 95340

  • Study site

    Norfolk, Virginia, 23507

  • Study site

    Orlando, Florida, 32803

  • Study site

    Peoria, Illinois, 61606

Other trials in United States

India6 sites

  • Study site

    Bandra, Mumbai

  • Study site

    Hyderabad, Andhra Pradesh, 500 034

  • Study site

    Multiple Locations, New Delhi

  • Study site

    Multiple Locations

  • Study site

    Rajasthan, Rajasthan

  • Study site

    Thellakom, Kottayam

Other trials in India

Romania5 sites

  • Study site

    Bucharest, 014461

  • Study site

    Bucharest, 021659

  • Study site

    Bucharest, 041914

  • Study site

    Bucharest, 050098

  • Study site

    Bucharest, 7000

Other trials in Romania

Hungary4 sites

  • Study site

    Markusovszky U. 3., H-9700 Szombathely

  • Study site

    Nyíri U. 38., H-6000 Kecskemét

  • Study site

    Seregélyesi, Székesfehérvár, 8000

  • Study site

    Tószegi U. 21., H-5004 Szolnok

Other trials in Hungary

Italy4 sites

  • Study site

    Genova

  • Study site

    Multiple Locations, Pisa

  • Study site

    Multiple Locations

  • Study site

    Roma, 00168

Other trials in Italy

Ukraine4 sites

  • Study site

    Kiev, 01151

  • Study site

    Kyiv, 02091

  • Study site

    Kyiv, 02660

  • Study site

    Odesa, 65014

Other trials in Ukraine

Denmark3 sites

  • Study site

    Copenhagen, 2400

  • Study site

    Copenhagen South, 2300

  • Study site

    Frederiksberg, 2000

Other trials in Denmark

Poland3 sites

  • Study site

    Ostrowiec Świętokrzyski, 27-400

  • Study site

    Piotrkow Trybunalski

  • Study site

    Warsaw, 01-211

Other trials in Poland

Serbia2 sites

  • Study site

    Belgrade, 11000

  • Study site

    Kamenitz, 21204

Other trials in Serbia

United Kingdom2 sites

  • Study site

    Newcastle upon Tyne

  • Study site

    Nottingham, NG7 2UH

Other trials in United Kingdom

Croatia1 site

  • Study site

    Multiple Locations

Other trials in Croatia

Sweden1 site

  • Study site

    Gothenburg, 41345

Other trials in Sweden

About this study

Official title: 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).

Conditions
Arrhythmias
Being tested
Double-blind investigational anti-arrhythmic, GAP-486
Keywords
Arrhythmias
Medical subject headings
Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Double-blind investigational anti-arrhythmicDrug

  • GAP-486Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

  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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2005 (estimated)
  2. Study start1 Jun 2005
  3. Primary completion1 Nov 2006
  4. Study completion1 Nov 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
500 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00124891
Sponsor's protocol ID
3163K1-200
Status last verified
Apr 2022
First submitted
13 Jul 2005
Last updated
3 May 2022
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Double-blind investigational anti-arrhythmic and GAP-486 in people with Arrhythmias, run by Wyeth is now a wholly owned subsidiary of Pfizer at 75 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 75 sites in Canada, Brazil, Mexico, Russia, United States and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The total number of ventricular beats recorded by Holter monitoring during the 24 hr. on-therapy phase.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00124891.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in