Currax Pharmaceuticals
Nashville, Tennessee, 37208, United States
NCT Number: NCT06089824
This study will assess a retrospective cohort of users of Mysimba/Contrave with up to 548 days (~18 months) after initiation with treatment with Mysimba/Contrave. This study will describe Mysimba/Contrave utilisation and incidence of AESIs for users compliant and non-compliant with the SmPC.
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Observational
Nashville, Tennessee, 37208, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Patient demographics (years of age on index date)
Time frame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Patient demographics (sex [male/female] on index date)
Time frame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Clinically recorded race (i.e., White, Black or African American, Asian, or other/unknown) and ethnicity (i.e., Hispanic or Latino, Non-Hispanic or Latino, or unknown)
Time frame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Smoking status (i.e., current or ever)
Time frame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Existing comorbidities:
Time frame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
History of substance abuse/dependencies; including acute opioid withdrawal
Time frame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
History of the following medical conditions:
Time frame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Pregnancy status.
Time frame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Breastfeeding status.
Time frame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Mysimba/Contrave initiation includes number of prescriptions
Time frame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Mysimba/Contrave initiation includes number of treatment episodes
Time frame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Mysimba/Contrave initiation includes duration between prescriptions
Time frame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Height (meters) (most recent value on or before the index date)
Time frame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Weight (kg) (most recent value on or before the index date)
Time frame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
BMI (kg/m2) (most recent value on or before the index date) (obtained directly from data sources; BMI may be calculated if height and weight available)
Time frame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Mysimba/Contrave use includes the number and percentage of patients compliant with the SmPC.
Time frame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Mysimba/Contrave use includes the number and percentage of patients non-compliant with the SmPC.
Currax Pharmaceuticals
Industry
Drug Utilisation and Safety Study of Mysimba in Europe and Contrave in the United States
Acronym: DUS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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