A Study to Test the Safety and Tolerability of a New Medication in the Treatment of Schizophrenia

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Sunovion

ClinicalTrials.gov Identifier:

NCT00088621

First received: July 30, 2004

Last updated: September 6, 2011

Last verified: September 2011

History of Changes

Results First Received: February 11, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Schizophrenia
Intervention:	Drug: Lurasidone 80mg tablet

Participant Flow

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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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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Lurasidone 80 mg	Lurasidone 80mg oral tablet. The number of subjects that represent the participant flow is based on the number of subjects that entered the extension study which is 61 subjects.

Participant Flow: Overall Study

	Lurasidone 80 mg
STARTED	61
COMPLETED	7
NOT COMPLETED	54

Baseline Characteristics

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Reporting Groups

	Description
Lurasidone 80 mg	Lurasidone 80mg oral tablet. The number of subjects that represent the baseline must have taken 1 dose of study medication and had post-baseline assessment. 2 subjects were randomized and did not take study medication and thus 59 subjects is listed in the baseline group.

Baseline Measures

	Lurasidone 80 mg
Number of Participants [units: participants]	59
Age [units: years] Mean ± Standard Deviation	41.3 ± 11.05
Gender [units: participants]
Female	15
Male	44
Region of Enrollment [units: participants]
United States	59

Outcome Measures

1. Primary:

Number of Subjects With an Adverse Events in a One Year Open Label Lurasidone Study [ Time Frame: 1 year ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Josephine Cucchiaro, Executive Director
Organization: Sunovion
phone: 201-592-2050
e-mail: josephine.cucchiaro@sunovion.com

No publications provided

Responsible Party:	Sunovion
ClinicalTrials.gov Identifier:	NCT00088621 History of Changes
Other Study ID Numbers:	D1050199
Study First Received:	July 30, 2004
Results First Received:	February 11, 2011
Last Updated:	September 6, 2011
Health Authority:	United States: Food and Drug Administration

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