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NCT04315792 · ClinicalTrials.gov registry record · Phase 3
Evaluate Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients
A Phase 3 study, sponsored by Jina Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 124
- Enrollment target
NCT04315792: Completed Phase 3 study, sponsored by Jina Pharmaceuticals.
NCT04315792 is a Phase 3 study that has completed, run by Jina Pharmaceuticals. The registered enrollment target is 124 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04315792, a Phase 3 study, has completed, sponsored by Jina Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 124 participants
- Enrollment target
Study Summary
The present study aims to evaluate the efficacy and safety of 8 mg endoxifen in the study population. As endoxifen represents a totally new class of drugs in the treatment of the bipolar disorder, it is essential to compare the drug against placebo to rule out the psychological influence upon study results. More so given the risks to patients and their communities from a medication whose efficacy has not been thoroughly evaluated against a placebo control. Thus, Endoxifen will be compared to placebo to demonstrate that the test product is active and to establish that the study is sufficiently sensitive to detect differences between the investigational products.
Primary Outcome
Mean change in total YMRS score at Day 21 against baseline (in-patient setup)
Interventions
- DRUG Placebo oral tablet
- DRUG Endoxifen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2020-08-03 |
| Est. Completion | 2021-08-25 |
| Phase | Phase 3 |
What the finished NCT04315792 record still lists
NCT04315792 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo oral tablet is the first listed.
NCT04315792 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04315792 about?
NCT04315792 is a clinical study titled "Evaluate Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients". The present study aims to evaluate the efficacy and safety of 8 mg endoxifen in the study population. As endoxifen represents a totally new class of drugs in the treatment of the bipolar disorder, it is essential to compare the drug against placebo to rule out the psychological influence upon study ...
What is the current status of trial NCT04315792?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 124 participants. The study started on 2020-08-03. Estimated completion is 2021-08-25.
What interventions are being tested in trial NCT04315792?
The interventions under investigation include: Placebo oral tablet (DRUG), Endoxifen (DRUG).
Who is sponsoring clinical trial NCT04315792?
This trial is sponsored by Jina Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04315792's enrollment target sits among peer trials
124 1610th of 2000 higher than 386 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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