Back to resultsA Methodological Open Label Cross-Over Controlled Study To Assess The Effect Of Drugs On Ventricular Repolarization and QT Interval At Fixed Heart Rate Under Autonomic Blockade
Primary Purpose
Patients With Pace Makers But no Evidence of Ischemic Heart Disease
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
GTN
Moxifloxacin
Sponsored by
About this trial
This is an interventional educational/counseling/training trial for Patients With Pace Makers But no Evidence of Ischemic Heart Disease
Eligibility Criteria
Inclusion Criteria: Patients with pace-makers but otherwise normal ventricular function Exclusion Criteria: Nitrates, beta blockers
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Outcomes
Primary Outcome Measures
QT and QTc changes at two different pacing rates in atrially paced patients
Secondary Outcome Measures
Change in QT and QTcF before and after Moxifloxacin with and without autonomic blockade at each pacing rate Change in QT and QTcF before and after autonomic blockade at each pacing rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00174512
Brief Title
A Methodological Open Label Cross-Over Controlled Study To Assess The Effect Of Drugs On Ventricular Repolarization and QT Interval At Fixed Heart Rate Under Autonomic Blockade
Official Title
A Methodological Open-Label Cross-Over Controlled Study To Assess The Effect Of Drugs On Ventricular Repolarisation and QT Interval At Fixed Heart Rate Under Autonomic Blockade
Study Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
Brief Summary
To assess the effects of GTN on QT and QTc in subjects with And without atrial pacing. This will be done with and without autonomic blockade at two different pacing rates. Moxifloxacin effect on QT and QTc will also be assessed in atrially paced patients at two different pacing rates with and without autonomic blockade
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Pace Makers But no Evidence of Ischemic Heart Disease
7. Study Design
Primary Purpose
Educational/Counseling/Training
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GTN
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin
Primary Outcome Measure Information:
Title
QT and QTc changes at two different pacing rates in atrially paced patients
Secondary Outcome Measure Information:
Title
Change in QT and QTcF before and after Moxifloxacin with and without autonomic blockade at each pacing rate Change in QT and QTcF before and after autonomic blockade at each pacing rate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with pace-makers but otherwise normal ventricular function
Exclusion Criteria:
Nitrates, beta blockers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Bruxelles (Brussels)
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Glasgow
State/Province
Scotland
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Leicester
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Liverpool
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Manchester
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9001226&StudyName=A+Methodological+Open+Label+Cross%2DOver+Controlled+Study+To+Assess+The+Effect+Of+Drugs+On+Ventricular+Repolarization+and+QT+Interval+At+Fixed+Heart+Rate+Under+Autonomic+Bloc
Description
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A Methodological Open Label Cross-Over Controlled Study To Assess The Effect Of Drugs On Ventricular Repolarization and QT Interval At Fixed Heart Rate Under Autonomic Blockade
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