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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator |
| |
| B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irbesartan | Drug | Tablets, Oral, 300 mg, once daily, 30 days. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miguel Angel Sanchez Zamorano, MD | Medical Department, Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Madrid | 28040 | Spain | |||
| Local Institution |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000077405 | Irbesartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Placebo | Drug | Tablets, Oral, 0 mg, once daily, 30 days. |
|
| Refractoriness dispersion | The measures are taken after 31 days of irbesartan treatment |
| Madrid |
| 28046 |
| Spain |
| Local Institution | Madrid | 28905 | Spain |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D013141 | Spiro Compounds |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |