Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD0837 · 3 trials · 3 indications
The premature discontinuation of study or study drug due to any reason
The premature discontinuation of study drug due to any reason
\|The premature discontinuation of study due to any reason
\[(number of doses dispensed-number of doses returned)/number of days between visits\]\*100
(number of visits attended acroos the time of study divided by the number of expected visits according to the time of entry into study)\*100
Participants
Number of patients with a bleeding event while on study drug. Patients with multiple events are counted once
Change in Creatinine values from baseline to week 12 visit for patients while on study drug (week 12 visit-baseline)
Number of patients while on study drug with ALAT\>=3 times upper limit of normal.l
Number of patients while on study drug with Bilirubin\>=2 times upper limit of normal
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| 3 | EXPERIMENTAL | AZD0837 300 mg |
| 4 | EXPERIMENTAL | AZD0837 150 mg |
| 5 | ACTIVE_COMPARATOR | Vitamin-K antagonist at INR 2-3 |
| Name | Type | Description |
|---|---|---|
| AZD0837 | DRUG | ER formulation |
| Aspirin | DRUG | Oral form |
| VKA INR 2-3 | DRUG | Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5 |
| Vitamin-K antagonist at INR 2-3 | DRUG | Tablet, PO for a period of 3-9 months. |
Inclusion Criteria: * Either one of the following risk factors is sufficient for inclusion (high risk patient) * Previous cerebral ischaemic attack (stroke or transient ischaemic attack (TIA), \>30 days prior to randomization) * Previous systemic embolism or at least one of the following risk facto...
AZD0837 is an investigational oral small molecule developed for the prevention of stroke and systemic embolic events in patients with nonvalvular atrial fibrillation. It has been studied in persistent or permanent nonvalvular atrial fibrillation, including patients who are not taking vitamin-K antagonists. It is not approved for any indication.
AZD0837 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca sponsored the Phase 2 clinical program evaluating the drug in patients with nonvalvular atrial fibrillation.
AZD0837 is in Phase 2 clinical development. All three of its reported trials were Phase 2 studies, and all have been completed. The drug remains investigational and has not been approved by the FDA or any other regulatory agency for the prevention of stroke or systemic embolic events.
AZD0837 has been evaluated in three completed Phase 2 trials: NCT00684307, which studied prevention of stroke and systemic embolic events in nonvalvular atrial fibrillation with 1,084 patients; NCT00645853, a long-term safety study in 523 patients; and NCT00623779, which enrolled 128 atrial fibrillation patients not taking vitamin-K antagonists.
The AZD0837 Phase 2 program used randomized, double-blind, active-controlled designs. The largest trial, NCT00684307, enrolled 1,084 patients with nonvalvular atrial fibrillation. NCT00645853 assessed long-term safety in 523 patients with persistent or permanent nonvalvular atrial fibrillation, and NCT00623779 enrolled 128 patients not taking vitamin-K antagonists across six European countries.