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NCT01377233 · ClinicalTrials.gov registry record · Phase 2
Study of the Safety, Tolerability, and Pharmacokinetics of Once Weekly Zicronapine in Patients With Schizophrenia
A Phase 2 study, sponsored by H. Lundbeck A/S.
- Completed
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
NCT01377233: Completed Phase 2 study, sponsored by H. Lundbeck A/S.
NCT01377233 is a Phase 2 study that has completed, run by H. Lundbeck A/S. The registered enrollment target is 46 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01377233, a Phase 2 study, has completed, sponsored by H. Lundbeck A/S.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
Study Summary
The main purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of once weekly dosing of zicronapine, compared to daily dosing of zicronapine.
Primary Outcome
Number of patients with treatment-emergent adverse events during each of the two study periods plus corresponding safety follow-up period. Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total)
Interventions
- DRUG Zicronapine open-label lead-in 10 mg daily
- DRUG Zicronapine 10 mg daily
- DRUG Zicronapine 20 mg once weekly
- DRUG Zicronapine 30 mg once weekly
- DRUG Zicronapine 45 mg once weekly
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2011-07 |
| Phase | Phase 2 |
What the finished NCT01377233 record still lists
NCT01377233 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 5 interventions - of which Zicronapine open-label lead-in 10 mg daily is the first listed.
NCT01377233 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01377233 about?
NCT01377233 is a clinical study titled "Study of the Safety, Tolerability, and Pharmacokinetics of Once Weekly Zicronapine in Patients With Schizophrenia". The main purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of once weekly dosing of zicronapine, compared to daily dosing of zicronapine.
What is the current status of trial NCT01377233?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2011-07.
What interventions are being tested in trial NCT01377233?
The interventions under investigation include: Zicronapine open-label lead-in 10 mg daily (DRUG), Zicronapine 10 mg daily (DRUG), Zicronapine 20 mg once weekly (DRUG), Zicronapine 30 mg once weekly (DRUG), Zicronapine 45 mg once weekly (DRUG).
Who is sponsoring clinical trial NCT01377233?
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 NCT01377233's enrollment target sits among peer trials
46 1286th of 2000 higher than 705 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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