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NCT00790192 · ClinicalTrials.gov registry record · Phase 3
Lurasidone HCL - A 6-week Phase 3 Study of Patients With Acute Schizophrenia.
A Phase 3 study of Schizophrenia, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 3
- Development phase
- 488
- Enrollment target
- 20
- Study locations
NCT00790192: Completed Phase 3 study of Schizophrenia, sponsored by Sumitomo Pharma America.
NCT00790192 is a Phase 3 study of Schizophrenia that has completed, run by Sumitomo Pharma America. The registered enrollment target is 488 participants, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (125% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00790192, a Phase 3 study of Schizophrenia, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 488 participants
- Enrollment target
- 20
- Study locations
Study Summary
Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe as compared with quetiapine XR short term among acutely psychotic patients with chronic schizophrenia.
Primary Outcome
The PANSS (Positive and Negative Syndrome Scale) is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Lurasidone
- DRUG Quetiapine XR
Study Locations (20)
California
- Clinical Pharmacological Studies, Inc. - Cerritos
- Comprehensive Neuroscience, Inc - Cerritos
- Clinical Innovations, Inc. - Costa Mesa
- Synergy Escondido - Escondido
- Collaborative Neuroscience Network - Garden Grove
- Apostle Clinical Trials, Inc. - Long Beach
- California Clinical Trials - Paramount
- Pasadena Research Institute - Pasadena
- CNRI-Los Angeles. LLC - Pico Rivera
- Clinical Innovations, Inc. - Riverside
- CNRI-San Diego - San Diego
- UCSD Medical Center - Sandeigo
Arkansas
- K&S Professional Research Services, LLC - Little Rock
- Woodland International Research Group - Little Rock
Florida
- Florida Clinical Research Center - Bradenton
- Florida Clinical Research Center, LLC - Fruitland Park
Louisiana
- Lake Charles Clinical Trials - Lake Charles
- Booker, J. Gary, MD. APMC - Shreveport
Colorado
- Segal Institute for Clinical Research - Highlands Ranch
District of Columbia
- Comprehensive Neuroscience, Inc. - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 488 participants |
| Start Date | 2008-10 |
| Est. Completion | 2010-07 |
| Phase | Phase 3 |
What the finished NCT00790192 record still lists
NCT00790192 is an interventional study that assigns participants to a tested intervention. The registered 488 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 (125% 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.
NCT00790192 names 20 study sites across 6 states, led by California, Arkansas, Florida.
Frequently Asked Questions
What is clinical trial NCT00790192 about?
NCT00790192 is a clinical study titled "Lurasidone HCL - A 6-week Phase 3 Study of Patients With Acute Schizophrenia.". Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe as compared with quetiapine XR short term among acutely psychotic patients with chronic schizophrenia.
What is the current status of trial NCT00790192?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 488 participants. The study started on 2008-10. Estimated completion is 2010-07.
What conditions does trial NCT00790192 study?
This clinical trial studies the following conditions: Schizophrenia.
What interventions are being tested in trial NCT00790192?
The interventions under investigation include: Placebo (DRUG), Lurasidone (DRUG), Quetiapine XR (DRUG).
Who is sponsoring clinical trial NCT00790192?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00790192 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, District of Columbia, Florida. 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 NCT00790192's enrollment target sits among peer trials
488 40th of 315 higher than 276 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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