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NCT03593213 · ClinicalTrials.gov registry record · Phase 3
Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Participants With Schizophrenia
A Phase 3 study, sponsored by AbbVie.
- Terminated
- Registry status
- Phase 3
- Development phase
- 587
- Enrollment target
NCT03593213: Clinical Trial Phase 3 study, sponsored by AbbVie.
NCT03593213 is a Phase 3 study that was terminated before completion, run by AbbVie. The registered enrollment target is 587 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03593213, a Phase 3 study, was terminated before completion, sponsored by AbbVie.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 587 participants
- Enrollment target
Study Summary
1. To evaluate the efficacy and safety of cariprazine at a target dose of 4.5 milligram per day (mg/d) compared with placebo in prevention of relapse in patients with schizophrenia 2. To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/d compared with placebo in prevention of relapse in patients with schizophrenia who were initially stabilized on a target dose of 4.5 mg/d
Primary Outcome
Time to Relapse is the number of days from randomization to first relapse. Relapse is defined as any 1 of the following: * Increase in Positive and Negative Syndrome Scale(PANSS) by ≥30% for participants who had total score of ≥50 at randomization or ≥10-point increased score with total score \<50 at randomization \[PANSS=30 questions where 1=absence of symptoms to 7=extremely severe symptom;total score=30 to 210;higher score more severe symptoms\] * Increase in Clinical Global Impression-Seve
Interventions
- DRUG Placebo
- DRUG Cariprazine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 587 participants |
| Start Date | 2018-07-30 |
| Est. Completion | 2021-02-11 |
| Phase | Phase 3 |
Why NCT03593213 stopped before completion
NCT03593213 is an interventional study that assigns participants to a tested intervention. The registered 587 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 (24% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03593213 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03593213 about?
NCT03593213 is a clinical study titled "Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Participants With Schizophrenia". 1. To evaluate the efficacy and safety of cariprazine at a target dose of 4.5 milligram per day (mg/d) compared with placebo in prevention of relapse in patients with schizophrenia 2. To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/d compared with placebo in prevention ...
What is the current status of trial NCT03593213?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 587 participants. The study started on 2018-07-30. Estimated completion is 2021-02-11.
What interventions are being tested in trial NCT03593213?
The interventions under investigation include: Placebo (DRUG), Cariprazine (DRUG).
Who is sponsoring clinical trial NCT03593213?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03593213's enrollment target sits among peer trials
587 645th of 2000 higher than 1,354 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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