Status:
COMPLETED
Real-World Evidence on the Cardiovascular Safety of CONTRAVE® in the United States (U.S.)
Lead Sponsor:
Currax Pharmaceuticals
Conditions:
Obesity
Eligibility:
All Genders
18+ years
Brief Summary
The fixed-dose combination of naltrexone 8mg and bupropion 90mg extended-release oral tablet is marketed under the trade name CONTRAVE® in the U.S. In this protocol, the investigators propose to gener...
Detailed Description
The study will assess whether patients who initiate treatment with NB are at an elevated risk of MACE compared with patients who initiated treatment with lorcaserin, an active comparator chosen to red...
Eligibility Criteria
Inclusion
- For the main objective (1.0, 1.1), patients are eligible if they meet the following Inclusion Criteria:
- Have at least one prescription for NB between September 2014 and February 2020, including concurrent prescriptions (within 15 days) for naltrexone and bupropion; or have at least one prescription for lorcaserin;
- Have at least 180 days of data available prior to cohort entry with no evidence of prescriptions or dispensings of NB or lorcaserin;
- Have at least one BMI value available in the 180 days prior to cohort entry, inclusive of the index date;
- Have documentation of at least one outpatient medical visit 180 or more days prior to cohort entry, and at least one healthcare interaction in the 180 days prior to cohort entry;
- Are at least 18 years of age on the cohort entry date.
- For the main objective, patients are not eligible if they have a diagnosis of any of the following conditions in the 180 days before the cohort entry date:
- Epilepsy;
- Bulimia;
- Anorexia nervosa;
- Surgical procedure for weight loss.
Exclusion
Key Trial Info
Start Date :
September 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
31889 Patients enrolled
Trial Details
Trial ID
NCT06090461
Start Date
September 1 2014
End Date
December 1 2022
Last Update
June 25 2025
Active Locations (1)
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1
Currax Pharmaceuticals
Brentwood, Tennessee, United States, 37027