Status:
COMPLETED
Long-term Extension Trial of Asenapine in Subjects With Schizophrenia (Study P06125)
Lead Sponsor:
Organon and Co
Collaborating Sponsors:
Meiji Seika Pharma Co., Ltd.
Conditions:
Schizophrenia
Eligibility:
All Genders
20-64 years
Phase:
PHASE3
Brief Summary
This is a multi-site, randomized fixed-flexible dose long-term study of asenapine in participants with schizophrenia. The first six weeks of the study will be double-blind and the remainder of the stu...
Eligibility Criteria
Inclusion
- Participant has completed 42-day drug administration in the preceding short-term study (Protocol P06124), has exhibited efficacy (CGI-I at the completion of the preceding short-term study of markedly improved, moderately improved, or slightly improved), has no significant safety problems, and has been judged appropriate for study participation by the investigator.
- Male and female participants. Women who are of childbearing potential (i.e., not surgically sterile or post menopausal for at least 1 year) must use medically acceptable birth control. Medically acceptable birth control includes condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD, insert or copper-containing IUD, hormone-releasing IUD, systemic hormonal contraceptives, and surgical sterilization (eg, hysterectomy or tubal ligation). Male participants must agree to use condoms during their participation in the study.
- Participant must have been explained the nature of the study by the investigator, and be able to provide written consent prior to the conduct of the tests/observation of the clinical study.
Exclusion
- A participant must not have any clinically significant abnormal laboratory, vital sign, physical examination, or electrocardiogram (ECG) findings that, in the investigator's opinion, preclude the participant's participation in the study
- A participant must not have a positive pregnancy test or be planning to become pregnant during the term of the study;
- A participant must not receive antipsychotics, antidepressants, mood stabilizers, anti-epileptics, monoamine oxidase inhibitors, St. John's Wort, antiemetics that are dopamine antagonist, or traditional herbal medication for psychiatric symptoms at the baseline;
- A participant must not be at risk of harming themselves or others, in the investigator's opinion;
- A participant must not have been determined to be unsuitable by an investigator.
Key Trial Info
Start Date :
May 25 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 22 2015
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT01142596
Start Date
May 25 2010
End Date
April 22 2015
Last Update
May 28 2024
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