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NCT01235559 · ClinicalTrials.gov registry record · Phase 3
A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25305)
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 604
- Enrollment target
NCT01235559 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 604 participants.
The verdict
NCT01235559, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 604 participants
- Enrollment target
Study Summary
This randomized, multi-center double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 (bitopertin) in patients with sub-optimally controlled symptoms of schizophrenia. Patients, on stable treatment with antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching placebo for 52 weeks, followed by an optional treatment extension for up to 3 years.
Interventions
- DRUG Placebo
- DRUG bitopertin [RO4917838] level 1
- DRUG bitopertin [RO4917838] level 2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 604 participants |
| Start Date | 2010-12 |
| Est. Completion | 2015-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01235559
The ClinicalTrials.gov registry entry for NCT01235559 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 604 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01235559 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01235559 about?
NCT01235559 is a clinical study titled "A Study of RO4917838 (Bitopertin) in Patients With Sub-optimally Controlled Symptoms of Schizophrenia (WN25305)". This randomized, multi-center double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 (bitopertin) in patients with sub-optimally controlled symptoms of schizophrenia. Patients, on stable treatment with antipsychotics, will be randomized to receive d...
What is the current status of trial NCT01235559?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 604 participants. The study started on 2010-12. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01235559?
The interventions under investigation include: Placebo (DRUG), bitopertin [RO4917838] level 1 (DRUG), bitopertin [RO4917838] level 2 (DRUG).
Who is sponsoring clinical trial NCT01235559?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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