Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00713401 | Safety Study of Tecadenoson to Treat Atrial Fibrillation | PHASE2 | COMPLETED | 21 | — | — | Feb 1, 2008 | Jul 1, 2008 | Mar 11, 2014 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Cohort A | EXPERIMENTAL | Period 1: 75 mcg, i.v. bolus. Period 2: 75 mcg, i.v. bolus + esmolol low dose infusion |
| Cohort B | EXPERIMENTAL | Period 1: 150 mcg, i.v. bolus. Period 2: 150 mcg, i.v. bolus + esmolol low dose infusion |
| Cohort C | EXPERIMENTAL | Period 1: 300 mcg, i.v. bolus. Period 2: 300 mcg, i.v. bolus + esmolol low dose infusion |
| Cohort D | EXPERIMENTAL | Period 1: 75 mcg, i.v. bolus. Period 2: 75 mcg, i.v. bolus + esmolol high dose infusion |
| Cohort E | EXPERIMENTAL | Period 1: 150 or 300 mcg, i.v. bolus. Period 2: 150 or 300 mcg, i.v. bolus + esmolol high dose infusion |
| Name | Type | Description |
|---|---|---|
| Tecadenoson | DRUG | Tecadenoson administered intravenously (i.v.) |
| Esmolol | DRUG | Esmolol low dose infusion according to manufacturer's instructions |
Inclusion Criteria: * Have a diagnosis of atrial fibrillation in need of treatment for rate control * Be able and willing to abstain from any antiarrhythmics, including atrioventricular (AV) nodal blocking agents (except for esmolol per protocol), from no later than 8:00 p.m. on the day prior to do...