Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD0837 · 7 trials · 4 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 |
| HAB | EXPERIMENTAL | AZD0837 test- (in session 1) and reference- (in session 2) formulation with heavy breakfast |
| HBA | EXPERIMENTAL | AZD0837 reference- (in session 1) and test- (in session 2) formulation with heavy breakfast |
| LAB | EXPERIMENTAL | AZD0837 test- (in session 1) and reference- (in session 2) formulation with light breakfast |
| LBA | EXPERIMENTAL | AZD0837 reference- (in session 1) and test- (in session 2) formulation with light breakfast |
| 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. |
| Placebo | DRUG | Placebo |
| Ketoconazole | DRUG | tablets, orally, once daily for 3 days |
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 small molecule being studied for nonvalvular atrial fibrillation, including persistent or permanent nonvalvular atrial fibrillation. It has also been evaluated in healthy volunteers for pharmacokinetic studies. The drug is not approved and remains in clinical development.
AZD0837 is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company has sponsored clinical trials of the drug in patients with atrial fibrillation and in healthy volunteers.
AZD0837 is in Phase 1 clinical development. While some completed trials were Phase 2, the most recent trial listed is Phase 1. The drug is investigational and has not been approved by regulatory authorities.
AZD0837 has been studied in four completed trials, including NCT00623779 in patients with persistent or permanent nonvalvular atrial fibrillation, NCT00645853 for long-term safety, NCT00684307 for stroke prevention, and NCT00878618 in healthy volunteers. All trials are completed.
AZD0837 is the sole name provided for this investigational drug. No alternative names have been identified in the available information.