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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00610675 | Fifty Two Week Extension Trial of Org 50081 (Esmirtazapine) in the Treatment of Insomnia (P05708) | PHASE3 | COMPLETED | 346 | — | — | Dec 7, 2006 | Aug 17, 2009 | Oct 3, 2018 | - | — |
An Adverse Event (AE) is any untoward occurrence in a participant who is administered any pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding) symptom, or disease temporarily associated with the use of an investigational medicinal product (IMP), whether or not it is related to the IMP.
An Adverse Event (AE) is any untoward occurrence in a participant who is administered any pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding) symptom, or disease temporarily associated with the use of an IMP, whether or not it is related to the IMP.
| Arm | Type | Description |
|---|---|---|
| Esmirtazapine | EXPERIMENTAL | One tablet of Esmirtazapine, 4.5 mg orally, daily for up to 52 weeks |
| Name | Type | Description |
|---|---|---|
| Org 50081 | DRUG | One tablet daily |
Inclusion Criteria: * sign written informed consent after the scope and nature of the investigation have been explained to them, before any trial-related evaluations; * completed Protocol P05706 or P05707; * Have safety and efficacy assessments conducted per protocol P05706 or P05707. Exclusion Cr...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vanda Pharmaceuticals Inc. | VNDA | 3 | PHASE3 | Tasimelteon |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Suvorexant |
| Masimo Corporation | MASI | 1 | PHASE1 | Diprivan , Astra-Zeneca |
| Unity Health Toronto | UBX | 1 | PHASE2 | Lemborexant |
| ResMed Inc. | RMD | 1 | NA | Undisclosed |
| IQVIA Holdings Inc | IQV | 1 | — | Daridorexant, Non-orexin receptor antagonist medications for insomnia |