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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

NCT ID: NCT00174512

Last Updated: 2006-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Patients With Pace Makers But no Evidence of Ischemic Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

ECT

Blinding Strategy

NONE

Interventions

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GTN

Intervention Type DRUG

Moxifloxacin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with pace-makers but otherwise normal ventricular function

Exclusion Criteria

* Nitrates, beta blockers
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Bruxelles (Brussels), , Belgium

Site Status

Pfizer Investigational Site

Glasgow, Scotland, United Kingdom

Site Status

Pfizer Investigational Site

Leicester, , United Kingdom

Site Status

Pfizer Investigational Site

Liverpool, , United Kingdom

Site Status

Pfizer Investigational Site

London, , United Kingdom

Site Status

Pfizer Investigational Site

Manchester, , United Kingdom

Site Status

Countries

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Belgium United Kingdom

Related Links

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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

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Other Identifiers

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A9001226

Identifier Type: -

Identifier Source: org_study_id