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

Patients With Pace Makers But no Evidence of Ischemic Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00174512
• Other study ID #: A9001226
• Status: Completed
• Phase: Phase 1
• First received: September 12, 2005
• Last updated: November 7, 2006
• Start date: March 2005
• Est. completion date: June 2006

Study information

• Verified date: November 2006
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with pace-makers but otherwise normal ventricular function

Exclusion Criteria:

• Nitrates, beta blockers

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Coronary Artery Disease
• Myocardial Ischemia
• Patients With Pace Makers But no Evidence of Ischemic Heart Disease

Intervention

Drug:
• GTN

• Moxifloxacin

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles (Brussels)
United Kingdom	Pfizer Investigational Site	Glasgow	Scotland
United Kingdom	Pfizer Investigational Site	Leicester
United Kingdom	Pfizer Investigational Site	Liverpool
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Belgium,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QT and QTc changes at two different pacing rates in atrially paced patients
Secondary	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

External Links

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