Patients With Pace Makers But no Evidence of Ischemic Heart DiseasePhase 1NCT00174512
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
A Phase 1 study testing GTN and Moxifloxacin in people with Patients With Pace Makers But no Evidence of Ischemic Heart Disease, run by Pfizer at 6 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Patients With Pace Makers But no Evidence of Ischemic Heart Disease
- What is being tested?
- GTN and Moxifloxacin
- How many people
- 36 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Mar 2005to Jun 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with pace-makers but otherwise normal ventricular function
Who cannot join
- Nitrates, beta blockers
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United Kingdom5 sites
Pfizer Investigational Site
Glasgow, Scotland
Pfizer Investigational Site
Leicester
Pfizer Investigational Site
Liverpool
Pfizer Investigational Site
London
Pfizer Investigational Site
Manchester
About this study
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
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
- Being tested
- GTN, Moxifloxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GTNDrug
MoxifloxacinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMar 2005
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Pace Makers But no Evidence of Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00174512
- Sponsor's protocol ID
- A9001226
- Status last verified
- Nov 2006
- First submitted
- 12 Sep 2005
- Last updated
- 8 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00174512
- Acronym / sponsor ID
- A9001226
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Study completion
- Jun 2006
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with pace-makers but otherwise normal ventricular function
Key exclusion criteria (1 listed)
- Nitrates, beta blockers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GTN | Drug | – |
| Moxifloxacin | Drug | – |
Primary outcome
QT and QTc changes at two different pacing rates in atrially paced patients
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2006.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GTN and Moxifloxacin in people with Patients With Pace Makers But no Evidence of Ischemic Heart Disease, run by Pfizer at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QT and QTc changes at two different pacing rates in atrially paced patients. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2006.