Atrial FibrillationPhase 3NCT00352560
Electrophysiological Effects of Irbesartan in Patients With Paroxysmal Atrial Fibrillation (AF)
A Phase 3 study testing Irbesartan in people with Atrial Fibrillation, run by Bristol-Myers Squibb at 3 sites in Spain.
Trial summary
The main purpose of the study is to compare the mean AERP between treatment groups based on the hypothesis that in subjects with paroxysmal AF, Irbesartan prevents electrophysiological remodeling resulting in a prolonged atrial effective refractory period relative (AERP) to placebo. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Irbesartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 3 sitesSpain
- Study dates
- Jul 2006to Jun 2007
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recurrent PAF with indication for catheter ablation
Who cannot join
- Struct. Cardiopathy
- Mitral valve disease
- VEF<40%
- Myocardiopathy
- LVH
- cardiac surgery
Show all 11Show fewer
- AF reversible
- QT c>450
- Recent MI/stroke, severe HTN
- Requirement of ACEI/ARBs
- Coronary synd., HTA, liver disease
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Local Institution
Madrid, 28040
Local Institution
Madrid, 28046
Local Institution
Madrid, 28905
About this study
The main purpose of the study is to compare the mean AERP between treatment groups based on the hypothesis that in subjects with paroxysmal AF, Irbesartan prevents electrophysiological remodeling resulting in a prolonged atrial effective refractory period relative (AERP) to placebo.
- Conditions
- Atrial Fibrillation
- Being tested
- Irbesartan, Placebo
- Keywords
- Patients with Paroxysmal Atrial Fibrillation (PAF)
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrbesartanDrug
Also called Avapro
Tablets, Oral, 300 mg, once daily, 30 days.
PlaceboDrug
Tablets, Oral, 0 mg, once daily, 30 days.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: Irbesartan |
| B | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irbesartan effect on duration of Atrial Effective Refractory Period (AERP) in paroxysmal AF (PAF) patients.
Measured: The measures are taken after 31 days of irbesartan treatment
Secondary outcomes (3)
Irbesartan effect on A Function RP
Measured: The measures are taken after 31 days of irbesartan treatment
Irbesartan effect on atrial conduction intervals after basal & extra-stimuli, in PAF patients
Measured: The measures are taken after 31 days of irbesartan treatment
Refractoriness dispersion
Measured: The measures are taken after 31 days of irbesartan treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Investigators
- Miguel Angel Sanchez Zamorano, MD, Study director, Medical Department, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00352560
- Sponsor's protocol ID
- CV131-235
- Status last verified
- Jun 2008
- First submitted
- 12 Jul 2006
- Last updated
- 17 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological Effects of Irbesartan in Patients With Paroxysmal Atrial Fibrillation (AF)
- ClinicalTrials.gov ID
- NCT00352560
- Acronym / sponsor ID
- CV131-235
- Conditions
- Atrial Fibrillation
- Keywords
- Patients with Paroxysmal Atrial Fibrillation (PAF)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- Jul 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 14 Jul 2006 (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.
The main purpose of the study is to compare the mean AERP between treatment groups based on the hypothesis that in subjects with paroxysmal AF, Irbesartan prevents electrophysiological remodeling resulting in a prolonged atrial effective refractory period relative (AERP) to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Irbesartan |
| B | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Recurrent PAF with indication for catheter ablation
Key exclusion criteria (11 listed)
- Struct. Cardiopathy
- Mitral valve disease
- VEF<40%
- Myocardiopathy
- LVH
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 |
|---|---|---|
| IrbesartanAlso: AvaproTablets, Oral, 300 mg, once daily, 30 days. | Drug | A |
| PlaceboTablets, Oral, 0 mg, once daily, 30 days. | Drug | B |
Primary outcome
Irbesartan effect on duration of Atrial Effective Refractory Period (AERP) in paroxysmal AF (PAF) patients.
Time frame: The measures are taken after 31 days of irbesartan treatment
3 secondary outcomes
Irbesartan effect on A Function RP
Time frame: The measures are taken after 31 days of irbesartan treatment
Irbesartan effect on atrial conduction intervals after basal & extra-stimuli, in PAF patients
Time frame: The measures are taken after 31 days of irbesartan treatment
Refractoriness dispersion
Time frame: The measures are taken after 31 days of irbesartan treatment
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 17 Feb 2010.
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Atrial Fibrillation (AF)
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.
Miguel Angel Sanchez Zamorano, MD study director
Medical Department, Bristol-Myers Squibb
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Irbesartan in people with Atrial Fibrillation, run by Bristol-Myers Squibb at 3 sites in Spain.
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 11 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 17 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Irbesartan effect on duration of Atrial Effective Refractory Period (AERP) in paroxysmal AF (PAF) patients. (time frame: The measures are taken after 31 days of irbesartan treatment). 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 17 Feb 2010.