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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00174512
First Posted: September 15, 2005
Last Update Posted: November 8, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
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

Condition Intervention Phase
Patients With Pace Makers But no Evidence of Ischemic Heart Disease Drug: GTN Drug: Moxifloxacin Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • QT and QTc changes at two different pacing rates in atrially paced patients

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 36
Study Start Date: March 2005
Estimated Study Completion Date: June 2006
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with pace-makers but otherwise normal ventricular function

Exclusion Criteria:

  • Nitrates, beta blockers
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00174512


Locations
Belgium
Pfizer Investigational Site
Bruxelles (Brussels), Belgium
United Kingdom
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
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00174512     History of Changes
Other Study ID Numbers: A9001226
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: November 8, 2006
Last Verified: November 2006

Additional relevant MeSH terms:
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Moxifloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents