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NCT01376076 · ClinicalTrials.gov registry record · Phase 1
Effects of Cariprazine on Cardiac Repolarization in Patients With Schizophrenia
A Phase 1 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 1
- Development phase
- 129
- Enrollment target
NCT01376076: Completed Phase 1 study, sponsored by Forest Laboratories.
NCT01376076 is a Phase 1 study that has completed, run by Forest Laboratories. The registered enrollment target is 129 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (115% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01376076, a Phase 1 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 129 participants
- Enrollment target
Study Summary
This study will evaluate the effects of sequential multiple dose regimens of cariprazine on cardiac repolarization in patients with schizophrenia.
Primary Outcome
The effects of a therapeutic dosage (9 mg/day) and a supratherapeutic dosage (18 mg/day) of cariprazine on cardiac repolarization as determined by heart-rate-corrected QT intervals will be assessed on Day 20 and Day 34, respectively. The assay sensitivity of moxifloxacin 400 mg/day will be assessed on Day 6 and Day 35.
Interventions
- DRUG Cariprazine
- DRUG Risperidone/Moxifloxacin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2011-06 |
| Est. Completion | 2012-02 |
| Phase | Phase 1 |
What the finished NCT01376076 record still lists
NCT01376076 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (115% higher).
The record links to 0 conditions, and to 2 interventions - of which Cariprazine is the first listed.
NCT01376076 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01376076 about?
NCT01376076 is a clinical study titled "Effects of Cariprazine on Cardiac Repolarization in Patients With Schizophrenia". This study will evaluate the effects of sequential multiple dose regimens of cariprazine on cardiac repolarization in patients with schizophrenia.
What is the current status of trial NCT01376076?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 129 participants. The study started on 2011-06. Estimated completion is 2012-02.
What interventions are being tested in trial NCT01376076?
The interventions under investigation include: Cariprazine (DRUG), Risperidone/Moxifloxacin (DRUG).
Who is sponsoring clinical trial NCT01376076?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01376076's enrollment target sits among peer trials
129 451st of 2000 higher than 1,549 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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