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CompletedNCT00352560Updated Feb 17, 2010

Electrophysiological Effects of Irbesartan in Patients With Paroxysmal Atrial Fibrillation (AF)

A Phase 3 interventional study of Irbesartan and Placebo in Atrial Fibrillation, sponsored by Bristol-Myers Squibb. Completed at 3 sites in Spain. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-02-17.

Sponsored by Bristol-Myers Squibb · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Atrial Fibrillation

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Keywords

  • Patients with Paroxysmal Atrial Fibrillation (PAF)
03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's planned enrollment of 44 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Recurrent PAF with indication for catheter ablation

Exclusion criteria

Exclusion Criteria:

  • Struct. Cardiopathy
  • Mitral valve disease
  • VEF\<40%
  • Myocardiopathy
  • LVH
  • cardiac surgery
  • AF reversible
  • QT c>450
  • Recent MI/stroke, severe HTN
  • Requirement of ACEI/ARBs
  • Coronary synd., HTA, liver disease
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
44 participants (estimated)

Study arms

  • Active comparator
    A

    Drug: Irbesartan

  • Placebo comparator
    B

    Drug: Placebo

Interventions

  • DrugIrbesartan

    Tablets, Oral, 300 mg, once daily, 30 days.

    Also known as: Avapro

  • DrugPlacebo

    Tablets, Oral, 0 mg, once daily, 30 days.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Irbesartan effect on A Function RP

    Time frame: The measures are taken after 31 days of irbesartan treatment

  2. 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

  3. Refractoriness dispersion

    Time frame: The measures are taken after 31 days of irbesartan treatment

07

Study locations

3 sites
  • Local Institution
    Madrid, 28040, Spain
  • Local Institution
    Madrid, 28046, Spain
  • Local Institution
    Madrid, 28905, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00352560
Lead sponsor
Bristol-Myers Squibb
Collaborators
Sanofi
First posted
Jul 14, 2006
Start date
Jul 2006
Primary completion
Jun 2007
Completion
Jun 2007
Last update
Feb 17, 2010

Study contacts

Miguel Angel Sanchez Zamorano, MD
study director · Medical Department, Bristol-Myers Squibb
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.

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