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

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00174512

First received: September 12, 2005

Last updated: November 7, 2006

Last verified: November 2006

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

November 7, 2006

Start Date ^ICMJE

March 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00174512 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Change in QT and QTcF before and after Moxifloxacin without autonomic blockade at each pacing rate Change in QT and QTcF before and after Moxifloxacin with autonomic blockade at each pacing rate Change in QT and QTcF before and after autonomic blockade

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Patients With Pace Makers But no Evidence of Ischemic Heart Disease

Intervention ^ICMJE

Drug: GTN
Drug: Moxifloxacin

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with pace-makers but otherwise normal ventricular function

Exclusion Criteria:

Nitrates, beta blockers

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00174512

Other Study ID Numbers ^ICMJE

A9001226

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

November 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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