NCT00352560

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at below P25 for phase_3 atrial-fibrillation

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_3 atrial-fibrillation

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

February 17, 2010

Status Verified

June 1, 2008

Enrollment Period

11 months

First QC Date

July 12, 2006

Last Update Submit

February 15, 2010

Conditions

Atrial Fibrillation

Keywords

Patients with Paroxysmal Atrial Fibrillation (PAF)

Outcome Measures

Primary Outcomes (1)

  • Irbesartan effect on duration of Atrial Effective Refractory Period (AERP) in paroxysmal AF (PAF) patients.

    The measures are taken after 31 days of irbesartan treatment

Secondary Outcomes (3)

  • Irbesartan effect on A Function RP

    The measures are taken after 31 days of irbesartan treatment

  • Irbesartan effect on atrial conduction intervals after basal & extra-stimuli, in PAF patients

    The measures are taken after 31 days of irbesartan treatment

  • Refractoriness dispersion

    The measures are taken after 31 days of irbesartan treatment

Study Arms (2)

A

ACTIVE COMPARATOR
Drug: Irbesartan

B

PLACEBO COMPARATOR
Drug: Placebo

Interventions

IrbesartanDRUG

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

Also known as: Avapro
A
PlaceboDRUG

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

B

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recurrent PAF with indication for catheter ablation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Local Institution

Madrid, 28040, Spain

Location

Local Institution

Madrid, 28046, Spain

Location

Local Institution

Madrid, 28905, Spain

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Irbesartan

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsSpiro CompoundsTetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Study Officials

  • Miguel Angel Sanchez Zamorano, MD

    Medical Department, Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 12, 2006

First Posted

July 14, 2006

Study Start

July 1, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

February 17, 2010

Record last verified: 2008-06

Locations

ES(3)