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CompletedNCT00174512Updated Nov 8, 2006

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

A Phase 1 interventional study of GTN and Moxifloxacin in Patients With Pace Makers But no Evidence of Ischemic Heart Disease, sponsored by Pfizer. Completed at 6 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2006-11-08.

Sponsored by Pfizer · Phase 1, Interventional, and Educational/counseling/training

Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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

02

Conditions studied

  • Patients With Pace Makers But no Evidence of Ischemic Heart Disease
03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 36 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with pace-makers but otherwise normal ventricular function

Exclusion criteria

Exclusion Criteria:

  • Nitrates, beta blockers
05

Study design

Phase
Phase 1
Primary purpose
Educational/counseling/training
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
36 participants

Interventions

  • DrugGTN
  • DrugMoxifloxacin
06

What researchers measure

Primary outcomes

  1. QT and QTc changes at two different pacing rates in atrially paced patients

Secondary outcomes

  1. 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

07

Study locations

6 sites
  • Pfizer Investigational Site
    Bruxelles (Brussels), Belgium
  • 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, United Kingdom
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00174512
Lead sponsor
Pfizer
First posted
Sep 15, 2005
Start date
Mar 2005
Completion
Jun 2006
Last update
Nov 8, 2006

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2006. You cannot join it, but the record below documents what was studied.

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