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NCT01291511 · ClinicalTrials.gov registry record · Phase 3
Relapse Prevention Study in Patients With Schizophrenia
A Phase 3 study of Schizophrenia, sponsored by Vanda Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 635
- Enrollment target
- 20
- Study locations
NCT01291511: Completed Phase 3 study of Schizophrenia, sponsored by Vanda Pharmaceuticals.
NCT01291511 is a Phase 3 study of Schizophrenia that has completed, run by Vanda Pharmaceuticals. The registered enrollment target is 635 participants, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (193% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01291511, a Phase 3 study of Schizophrenia, has completed, sponsored by Vanda Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 635 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine whether Iloperidone is effective in the prevention of relapse in patients with schizophrenia
Primary Outcome
Relapse or impending relapse was defined as any of the following: hospitalization due to worsening of schizophrenia; increase (worsening) of the PANSS total score of greater than or equal to 30% from randomization, PANSS total score confirmed at a second visit conducted within 1-7 days; clinically significant emergent or worsening suicidal, homicidal, or aggressive behavior; a CGI-Improvement (CGI-I) score of 6 (much worse) or 7 (very much worse) after randomization; a dose increase in study med
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Iloperidone
Study Locations (20)
California
- Vanda Investigative Site - Anaheim
- Vanda Investigative Site - Bellflower
- Vanda Investigative Site - Costa Mesa
- Vanda Investigative Site - Escondido
- Vanda Investigative Site - La Habra
- Vanda Investigative Site - Oceanside
- Vanda Investigative Site - Orange
- Vanda Investigative Site - Pico Rivera
- Vanda Investigative Site - Riverside
- Vanda Investigative Site - San Diego
- Vanda Investigative Site - San Diego
- Vanda Investigative Site - San Diego
- Vanda Investigative Site - Santa Ana
Florida
- Vanda Investigative Site - Melbourne
- Vanda Investigative Site - Miami
- Vanda Investigative Site - Oakland Park
Georgia
- Vanda Investigative Site - Atlanta
- Vanda Investigative Site - Atlanta
Missouri
- Vanda Investigative Site - St Louis
New Hampshire
- Vanda Investigative Site - Nashua
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 635 participants |
| Start Date | 2011-02 |
| Est. Completion | 2015-03 |
| Phase | Phase 3 |
What the finished NCT01291511 record still lists
NCT01291511 is an interventional study that assigns participants to a tested intervention. The registered 635 participants enrollment target is mid-sized for trials with a published cap, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (193% higher).
The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01291511 names 20 study sites across 5 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT01291511 about?
NCT01291511 is a clinical study titled "Relapse Prevention Study in Patients With Schizophrenia". The purpose of this study is to determine whether Iloperidone is effective in the prevention of relapse in patients with schizophrenia
What is the current status of trial NCT01291511?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 635 participants. The study started on 2011-02. Estimated completion is 2015-03.
What conditions does trial NCT01291511 study?
This clinical trial studies the following conditions: Schizophrenia.
What interventions are being tested in trial NCT01291511?
The interventions under investigation include: Placebo (DRUG), Iloperidone (DRUG).
Who is sponsoring clinical trial NCT01291511?
This trial is sponsored by Vanda Pharmaceuticals, which has 68 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01291511 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Missouri, New Hampshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Schizophrenia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01291511's enrollment target sits among peer trials
635 23rd of 315 higher than 293 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia 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.
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