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
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Patients With Pace Makers But no Evidence of Ischemic Heart Disease
Intervention: GTN (Drug); Moxifloxacin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training
Primary outcome: QT and QTc changes at two different pacing rates in atrially paced patients
Secondary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with pace-makers but otherwise normal ventricular function
Exclusion Criteria:
- Nitrates, beta blockers
Locations and Contacts
Pfizer Investigational Site, Bruxelles (Brussels), Belgium
Pfizer Investigational Site, Leicester, United Kingdom
Pfizer Investigational Site, Liverpool, United Kingdom
Pfizer Investigational Site, London, United Kingdom
Pfizer Investigational Site, Manchester, United Kingdom
Pfizer Investigational Site, Glasgow, Scotland, United Kingdom
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: March 2005
Last updated: November 7, 2006
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