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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 is a Phase 3 study that has completed, run by Jina Pharmaceuticals. The registered enrollment target is 124 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04315792
The ClinicalTrials.gov registry entry for NCT04315792 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 124 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jina Pharmaceuticals, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo oral tablet is the first listed.
NCT04315792 reports 0 study locations.
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.
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