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NCT01491035 · ClinicalTrials.gov registry record · Phase 2
Pharmacokinetics and Tolerability of Vortioxetine (Lu AA21004) in Child and Adolescent Patients With Depressive or Anxiety Disorder
A Phase 2 study, sponsored by H. Lundbeck A/S.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
NCT01491035: Completed Phase 2 study, sponsored by H. Lundbeck A/S.
NCT01491035 is a Phase 2 study that has completed, run by H. Lundbeck A/S. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01491035, a Phase 2 study, has completed, sponsored by H. Lundbeck A/S.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
Study Summary
The objective of the study is to evaluate the pharmacokinetics of vortioxetine and its metabolites in connection with multiple oral dosing in child and adolescent patients with a DSM-IV-TR diagnosis of Depressive or Anxiety Disorder
Primary Outcome
Maximum plasma concentration of vortioxetine
Interventions
- DRUG Vortioxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2012-04 |
| Est. Completion | 2015-06 |
| Phase | Phase 2 |
What the finished NCT01491035 record still lists
NCT01491035 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 1 intervention - of which Vortioxetine is the first listed.
NCT01491035 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01491035 about?
NCT01491035 is a clinical study titled "Pharmacokinetics and Tolerability of Vortioxetine (Lu AA21004) in Child and Adolescent Patients With Depressive or Anxiety Disorder". The objective of the study is to evaluate the pharmacokinetics of vortioxetine and its metabolites in connection with multiple oral dosing in child and adolescent patients with a DSM-IV-TR diagnosis of Depressive or Anxiety Disorder
What is the current status of trial NCT01491035?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2012-04. Estimated completion is 2015-06.
What interventions are being tested in trial NCT01491035?
The interventions under investigation include: Vortioxetine (DRUG).
Who is sponsoring clinical trial NCT01491035?
This trial is sponsored by H. Lundbeck A/S, which has 72 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01491035's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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