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Study Evaluating GAP-486 in Non-sustained Ventricular Tachycardia

Primary Purpose

Arrhythmias

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Double-blind investigational anti-arrhythmic

GAP-486

About this trial

This is an interventional prevention trial for Arrhythmias focused on measuring Arrhythmias

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00124891

First Posted

July 13, 2005

Last Updated

April 28, 2022

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00124891

Brief Title

Study Evaluating GAP-486 in Non-sustained Ventricular Tachycardia

Official Title

Study Evaluating Subjects With Non-sustained Ventricular Tachycardia

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Terminated

Study Start Date

June 1, 2005 (Actual)

Primary Completion Date

November 1, 2006 (Actual)

Study Completion Date

November 1, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arrhythmias

Keywords

Arrhythmias

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

500 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Double-blind investigational anti-arrhythmic

Intervention Type

Drug

Intervention Name(s)

GAP-486

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials: