Safety and Tolerability Study of Drug to Treat Schizophrenia

This study has been completed.

Study NCT00044005 Information provided by Sunovion

First Received on August 16, 2002. Last Updated on September 6, 2011 History of Changes

Results First Received: February 16, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Schizophrenia
Interventions:	Drug: Lurasidone 20 mg Drug: Lurasidone 40 mg Drug: Lurasidone 80mg

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Lurasidone 20 mg	Lurasdione 20 mg oral tablets
Lurasidone 40 mg	Lurasidone 40 mg oral tablets
Lurasidone 80mg	Lurasidone 80mg oral tablets

Participant Flow: Overall Study

	Lurasidone 20 mg	Lurasidone 40 mg	Lurasidone 80mg
STARTED	32	33	33
COMPLETED	13	19	11
NOT COMPLETED	19	14	22

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Lurasidone 20 mg	Lurasdione 20 mg oral tablets
Lurasidone 40 mg	Lurasidone 40 mg oral tablets
Lurasidone 80mg	Lurasidone 80mg oral tablets

Baseline Measures

	Lurasidone 20 mg	Lurasidone 40 mg	Lurasidone 80mg	Total
Number of Participants [units: participants]	32	33	33	98
Age [units: years] Mean ± Standard Deviation	40.8 ± 7.8	42.2 ± 12.4	40.8 ± 10.7	41.3 ± 10.4
Gender [units: participants]
Female	11	12	5	28
Male	21	21	28	70
Region of Enrollment [units: participants]
United States	32	33	33	98

Outcome Measures

1. Primary:

Number of Participants With Adverse Events [ Time Frame: 6-months ]

Show Outcome Measure 1

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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
No text entered.

Results Point of Contact:

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

No publications provided

Responsible Party:	Sunovion
ClinicalTrials.gov Identifier:	NCT00044005 History of Changes
Other Study ID Numbers:	D1050174
Study First Received:	August 16, 2002
Results First Received:	February 16, 2011
Last Updated:	September 6, 2011
Health Authority:	United States: Food and Drug Administration