NCT00174512

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2005

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

November 8, 2006

Status Verified

November 1, 2006

First QC Date

September 12, 2005

Last Update Submit

November 7, 2006

Conditions

Patients With Pace Makers But no Evidence of Ischemic Heart Disease

Outcome Measures

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

Interventions

GTNDRUG
MoxifloxacinDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with pace-makers but otherwise normal ventricular function

You may not qualify if:

  • Nitrates, beta blockers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Pfizer Investigational Site

Bruxelles (Brussels), Belgium

Location

Pfizer Investigational Site

Glasgow, Scotland, United Kingdom

Location

Pfizer Investigational Site

Leicester, United Kingdom

Location

Pfizer Investigational Site

Liverpool, United Kingdom

Location

Pfizer Investigational Site

London, United Kingdom

Location

Pfizer Investigational Site

Manchester, United Kingdom

Location

Related Links

MeSH Terms

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
ECT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

March 1, 2005

Study Completion

June 1, 2006

Last Updated

November 8, 2006

Record last verified: 2006-11

Locations

GB(5)BE(1)