Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lu AA21004 · 1 trial · 1 indication
Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.
The number of participants with any markedly abnormal standard safety laboratory values collected at weeks 4, 12, 24, 36, 48 and 52 relative to baseline.
Change from baseline in participant's weight measured throughout study.
Vital signs will include body temperature (oral or tympanic measurement), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm).
Change from baseline in electrocardiograms measured throughout study.
Physical examination consists of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) cardiovascular system; (4) respiratory system; (5) gastrointestinal system; (6) dermatologic system; (7) extremities; (8) musculoskeletal system; (9) nervous system; (10) lymph nodes; and (11) physical examinations other than body systems described in (1) to (10).
| Arm | Type | Description |
|---|---|---|
| Lu AA21004 group | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Lu AA21004 | DRUG | Lu AA21004 10 mg, tablets, orally, once daily for 2 weeks; reduced to 5 mg or increased to 20 mg, once daily if necessary according to the responses and symptoms of participants for up to 50 weeks. |
Inclusion Criteria: 1. Has completed the double-blind treatment period of the preceding study (CCT-003) 2. Signs and dates a written, informed consent form for this study, different from that for the preceding study (CCT-003). 3. Has CGI-S score improved at least one point at completion of the 8-we...
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Lu AA21004 is an investigational small molecule being studied for the treatment of Major Depressive Disorder (MDD). It is in Phase 3 clinical development, though it is not yet approved and remains under investigation.
Lu AA21004 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Major Depressive Disorder.
Lu AA21004 is in Phase 3 clinical development for Major Depressive Disorder. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed, with results yet to be disclosed.
Lu AA21004 has one completed Phase 3 trial, NCT01395147, titled 'Long-Term Extension Study of Lu AA21004 in Participants With Major Depressive Disorder.' This study enrolled 119 participants in Japan and was not randomized, double-blind, or controlled.
Lu AA21004 is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for Major Depressive Disorder. The drug has not completed the regulatory approval process and remains under study.