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NCT03503318 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate TV-46000 as Maintenance Treatment in Adult and Adolescent Participants With Schizophrenia
A Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 544
- Enrollment target
NCT03503318 is a Phase 3 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 544 participants.
The verdict
NCT03503318, a Phase 3 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 544 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the efficacy, safety, and tolerability of different dose regimens of TV-46000 administered subcutaneously (SC) as compared to placebo during maintenance treatment in adult and adolescent participants with schizophrenia. The study will include male and female participants, 13 to 65 years of age, who have a confirmed diagnosis of schizophrenia, are clinically stable, and are eligible for risperidone treatment
Interventions
- DRUG Placebo
- DRUG TV-46000
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 544 participants |
| Start Date | 2018-04-27 |
| Est. Completion | 2020-12-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03503318
The ClinicalTrials.gov registry entry for NCT03503318 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 544 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 167 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03503318 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03503318 about?
NCT03503318 is a clinical study titled "Study to Evaluate TV-46000 as Maintenance Treatment in Adult and Adolescent Participants With Schizophrenia". The purpose of the study is to evaluate the efficacy, safety, and tolerability of different dose regimens of TV-46000 administered subcutaneously (SC) as compared to placebo during maintenance treatment in adult and adolescent participants with schizophrenia. The study will include male and female p...
What is the current status of trial NCT03503318?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 544 participants. The study started on 2018-04-27. Estimated completion is 2020-12-03.
What interventions are being tested in trial NCT03503318?
The interventions under investigation include: Placebo (DRUG), TV-46000 (DRUG).
Who is sponsoring clinical trial NCT03503318?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
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