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NCT01050582 · ClinicalTrials.gov registry record · Phase 4
A Study to Evaluate the Safety and the Effects of Risperidone Compared With Other Atypical Antipsychotic Drugs on the Growth and Sexual Maturation in Children
A Phase 4 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- Completed
- Registry status
- Phase 4
- Development phase
- 244
- Enrollment target
NCT01050582: Completed Phase 4 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
NCT01050582 is a Phase 4 study that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 244 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01050582, a Phase 4 study, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 244 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effects of risperidone compared with other atypical antipsychotic drugs on the physical maturity, growth and development of children, and the risk of prolactin-related adverse events (side effects) associated to these drugs.
Primary Outcome
Height (cm) measured at the study visit was converted to a Z-score based on the US Center for Disease Control 2000 growth charts for US subjects and European growth charts for ex-US subjects. A z-score indicates how many standard deviations a subject is away from the expected height for the subject's age and gender.
Interventions
- DRUG Risperidone
- DRUG Other atypical antipsychotic drugs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 244 participants |
| Start Date | 2009-10 |
| Est. Completion | 2011-07 |
| Phase | Phase 4 |
What the finished NCT01050582 record still lists
NCT01050582 is an interventional study that assigns participants to a tested intervention. The registered 244 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Risperidone is the first listed.
NCT01050582 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01050582 about?
NCT01050582 is a clinical study titled "A Study to Evaluate the Safety and the Effects of Risperidone Compared With Other Atypical Antipsychotic Drugs on the Growth and Sexual Maturation in Children". The purpose of this study is to evaluate the effects of risperidone compared with other atypical antipsychotic drugs on the physical maturity, growth and development of children, and the risk of prolactin-related adverse events (side effects) associated to these drugs.
What is the current status of trial NCT01050582?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 244 participants. The study started on 2009-10. Estimated completion is 2011-07.
What interventions are being tested in trial NCT01050582?
The interventions under investigation include: Risperidone (DRUG), Other atypical antipsychotic drugs (DRUG).
Who is sponsoring clinical trial NCT01050582?
This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01050582's enrollment target sits among peer trials
244 357th of 2000 higher than 1,643 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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