An Observational Drug Utilization Study of Asenapine in the United Kingdom (P08308)
Launched by ORGANON AND CO · Dec 21, 2011
Trial Information
Current as of May 28, 2025
Completed
Keywords
ClinConnect Summary
The data source for this study will be the Clinical Practice Research Database (CPRD) in the UK. New users of asenapine during the period following the UK marketing launch of asenapine will be identified in the CPRD. Use in Bipolar Disorder and other indications, as well as baseline demographic and physical characteristics, including prior health status, comorbidities, concomitant medications and healthcare resource utilization, will be described for the asenapine cohort, for participants aged 18 or greater. Use of asenapine in the general practice setting among pediatric participants will ...
Gender
ALL
Eligibility criteria
- Inclusion Criteria for Participants Treated with Asenapine:
- • At least 1 prescription for asenapine within the study period
- • Date of prescription occurs after the CPRD subject registration date or the database specific quality indicator date
- • A minimum of 365 or more days of evaluable baseline observation time, occurring prior to the date of prescription for asenapine
- Inclusion Criteria for Participants Treated with a Comparator:
- • Age 18 years or greater at the time participant receives a prescription for the comparator
- • At least 1 prescription for either aripiprazole, quetiapine, risperidone, olanzapine, ziprasidone, iloperidone, paliperidone, lurasidone, clozapine, amisulpride, sertindole or zotepine within the study period
- • Date of prescription occurs after the CPRD subject registration date or the database specific quality indicator date
- • A minimum of 365 or more days of evaluable baseline observation time, occurring prior to the date of prescription for either aripiprazole, quetiapine, risperidone, olanzapine, ziprasidone, iloperidone, paliperidone, lurasidone, clozapine, amisulpride, sertindole or zotepine
- Exclusion Criteria:
- • None
About Organon And Co
Organon & Co. is a global healthcare company dedicated to advancing women's health and improving patient outcomes through innovative therapies and solutions. With a strong focus on addressing unmet medical needs, Organon develops and commercializes a diverse portfolio of medicines, including reproductive health, contraception, and other critical areas affecting women's health. Committed to scientific excellence and collaboration, the company engages in clinical trials to explore new treatment avenues and enhance the quality of life for patients worldwide. Through its mission-driven approach, Organon strives to empower women and healthcare providers with the tools and resources necessary for informed decision-making and effective care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Medical Director
Study Director
Merck Sharp & Dohme LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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