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NCT00254202 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Iloperidone Compared With Placebo and Active Control in Subjects With Acute Schizophrenia
A Phase 3 study of Schizophrenia, sponsored by Vanda Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 593
- Enrollment target
- 20
- Study locations
NCT00254202: Completed Phase 3 study of Schizophrenia, sponsored by Vanda Pharmaceuticals.
NCT00254202 is a Phase 3 study of Schizophrenia that has completed, run by Vanda Pharmaceuticals. The registered enrollment target is 593 participants, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (173% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00254202, a Phase 3 study of Schizophrenia, has completed, sponsored by Vanda Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 593 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine the safety and efficacy of iloperidone compared to placebo and an active comparator in the treatment of patients with schizophrenia in acute exacerbation.
Primary Outcome
The PANSS is a 30-item scale developed to assess the severity of symptoms of schizophrenia. The PANSS items are divided into positive, negative, and general psychopathology factors. Items are rated on a scale of 1 (absent) to 7 (extremely severe). The PANSS-T score is the sum of scores for all 30 PANSS items (i.e., the sum of the three subscales), with a minimum score of 30 and a maximum score of 210. Higher scores indicate more severe symptoms. A negative change from baseline indicates improvem
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ziprasidone
- DRUG Iloperidone
Study Locations (20)
California
- Vanda Investigational Site - Anaheim
- Vanda Investigational Site - Cerritos
- Vanda Investigational Site - Garden Grove
- Vanda Investigational Site - Glendale
- Vanda Investigational Site - Los Angeles
- Vanda Investigational Site - National City
- Vanda Investigational Site - Oceanside
- Vanda Investigational Site - Paramount
- Vanda Investigational Site - Pico Rivera
- Vanda Investigational Site - San Diego
- Vanda Investigational Site - San Diego
- Vanda Investigational Site - San Diego
- Vanda Investigational Site - Santa Ana
- Vanda Investigational Site - Upland
Florida
- Vanda Investigational Site - Bradenton
- Vanda Investigational Site - Fort Lauderdale
- Vanda Investigational Site - Maitland
Georgia
- Vanda Investigational Site - Atlanta
- Vanda Investigational Site - Augusta
Arkansas
- Vanda Investigational Site - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 593 participants |
| Start Date | 2005-11-18 |
| Est. Completion | 2007-03-21 |
| Phase | Phase 3 |
What the finished NCT00254202 record still lists
NCT00254202 is an interventional study that assigns participants to a tested intervention. The registered 593 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 (173% higher).
The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT00254202 names 20 study sites across 4 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT00254202 about?
NCT00254202 is a clinical study titled "Efficacy and Safety of Iloperidone Compared With Placebo and Active Control in Subjects With Acute Schizophrenia". The purpose of this study is to determine the safety and efficacy of iloperidone compared to placebo and an active comparator in the treatment of patients with schizophrenia in acute exacerbation.
What is the current status of trial NCT00254202?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 593 participants. The study started on 2005-11-18. Estimated completion is 2007-03-21.
What conditions does trial NCT00254202 study?
This clinical trial studies the following conditions: Schizophrenia.
What interventions are being tested in trial NCT00254202?
The interventions under investigation include: Placebo (DRUG), Ziprasidone (DRUG), Iloperidone (DRUG).
Who is sponsoring clinical trial NCT00254202?
This trial is sponsored by Vanda Pharmaceuticals, which has 68 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00254202 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Georgia. 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 NCT00254202's enrollment target sits among peer trials
593 32nd of 315 higher than 284 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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