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Search / Trial NCT01498770

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.

Locations

Patients applied

0 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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