Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia
This study has been completed.
Sponsor:
Sunovion
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00549718
First received: October 24, 2007
Last updated: April 9, 2013
Last verified: April 2013
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Results First Received: November 8, 2010
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition: |
Schizophrenia |
| Intervention: |
Drug: Lurasidone HCl |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Lurasidone 40mg | Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug. |
| Lurasidone 80mg | lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug. |
| Lurasidone 120mg | Lurasidone 40 mg tablets taken once/day |
| Placebo | Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug. |
Participant Flow: Overall Study
| Lurasidone 40mg | Lurasidone 80mg | Lurasidone 120mg | Placebo | |
|---|---|---|---|---|
| STARTED | 125 | 123 | 124 | 128 |
| COMPLETED | 84 | 86 | 85 | 73 |
| NOT COMPLETED | 41 | 37 | 39 | 55 |
| Insufficient clinical response | 20 | 7 | 18 | 32 |
| Adverse Event | 6 | 8 | 7 | 3 |
| Lost to Follow-up | 4 | 2 | 0 | 6 |
| Withdrawal by Subject | 9 | 18 | 12 | 13 |
| Administrative | 2 | 2 | 2 | 1 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Lurasidone 40mg | Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug. |
| Lurasidone 80mg | lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug. |
| Lurasidone 120mg | Lurasidone 40 mg tablets taken once/day |
| Placebo | Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug. |
| Total | Total of all reporting groups |
Baseline Measures
| Lurasidone 40mg | Lurasidone 80mg | Lurasidone 120mg | Placebo | Total | |
|---|---|---|---|---|---|
|
Number of Participants
[units: participants] |
122 | 119 | 124 | 124 | 489 |
|
Age
[units: years] Mean ± Standard Deviation |
40.7 ± 11.1 | 38.6 ± 9.5 | 37.7 ± 11.2 | 38.2 ± 9.9 | 38.8 ± 10.5 |
|
Gender
[units: participants] |
|||||
| Female | 40 | 43 | 32 | 34 | 149 |
| Male | 82 | 76 | 92 | 90 | 340 |
|
Region of Enrollment
[units: participants] |
|||||
| France | 0 | 1 | 1 | 1 | 3 |
| United States | 70 | 64 | 70 | 67 | 271 |
| Malaysia | 2 | 2 | 2 | 2 | 8 |
| Ukraine | 13 | 12 | 12 | 14 | 51 |
| Romania | 9 | 9 | 9 | 9 | 36 |
| Russian Federation | 14 | 15 | 13 | 15 | 57 |
| India | 14 | 16 | 17 | 16 | 63 |
Outcome Measures
