| ID | Type | Description | Link |
|---|---|---|---|
| 2009-018215-53 | EudraCT Number |
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The primary objective of this study is to:
Assess whether the addition of dronedarone to existing conventional rate control therapy leads to a reduced ventricular rate after 1 week in patients with a high Heart Rate (HR) at rest during Atrial Fibrillation (AF) in comparison to an increase of conventional therapy.
The secondary objectives of this study are to compare both study arms with regard to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Addition of dronedarone | Experimental | Addition of Dronedarone to existing rate control medication (beta blocker and/or calcium antagonist) |
|
| Dose Increase | Active Comparator | Dose increase of existing rate control medication (beta blocker or calcium antagonist or digoxin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dronedarone | Drug | Pharmaceutical form: tablet Route of administration: oral Dose regimen: 400 mg twice daily for 12 weeks (+/- 5 days) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ventricular rate | One week |
| Measure | Description | Time Frame |
|---|---|---|
| Ventricular rate | 12 weeks | |
| Patients with registered AF episodes | Within the 12 weeks after randomization | |
| Patients with symptomatic AF episodes |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | PE Gouda | Netherlands |
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| Beta blocker or calcium antagonist or digoxin | Drug | Dose increase of beta blocker or calcium antagonist or digoxin |
|
| Within the 12 weeks after randomization |
| Severity of AF and AF-like symptoms | Within the 12 weeks after randomization |
| Premature study discontinuation | Premature study discontinuation for all reasons including those where the patients must go off study prematurely as per protocol (ie. in case of cardioversion during the 1st study week, 2nd cardioversion after the 1st study week, addition of anti-arrhythmic drug, ablation or other surgical AF related intervention) | Within the 12 weeks after randomization |
| Patients with symptomatic episodes of bradycardia | Within the 12 weeks after randomization |
| Patients with low heart rate (<60 bpm) | Within the 12 weeks after randomization |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077764 | Dronedarone |
| D000319 | Adrenergic beta-Antagonists |
| D002121 | Calcium Channel Blockers |
| D004077 | Digoxin |
| ID | Term |
|---|---|
| D000638 | Amiodarone |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D018674 | Adrenergic Antagonists |
| D018663 | Adrenergic Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |
| D049990 | Membrane Transport Modulators |
| D000077264 | Calcium-Regulating Hormones and Agents |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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