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

November 7, 2006 updated by: Pfizer

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

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

Study Overview

Status

Completed

Conditions

Patients With Pace Makers But no Evidence of Ischemic Heart Disease

Intervention / Treatment

Study Type

Interventional

Enrollment

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Belgium
- - Bruxelles (Brussels), Belgium
    - Pfizer Investigational Site
United Kingdom
- - Leicester, United Kingdom
    - Pfizer Investigational Site
  - Liverpool, United Kingdom
    - Pfizer Investigational Site
  - London, United Kingdom
    - Pfizer Investigational Site
  - Manchester, United Kingdom
    - Pfizer Investigational Site
- Scotland
  - Glasgow, Scotland, United Kingdom
    - Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients with pace-makers but otherwise normal ventricular function

Exclusion Criteria:

Nitrates, beta blockers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

To obtain contact information for a study center near you, click here.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Study Completion

June 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

November 8, 2006

Last Update Submitted That Met QC Criteria

November 7, 2006

Last Verified

November 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

A9001226

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.