At a glance
ClinicalIndex Comparison RecordN/ACompleted· 31,889 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Non-Interventional Study to Generate Real-World Evidence on the Cardiovascular Safety of CONTRAVE® in the United States (U.S.)
In Brief
An observational study for Obesity. Completed, enrolled 31,889 participants across 1 site.
Detailed 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 generate real-world evidence (RWE) from electronic health records (EHR) and linked claims data to assess the cardiovascular safety of CONTRAVE® and all combined use of naltrexone and bupropion (NB) in usual clinical practice.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartSep 2014
Primary CompletionDec 2022
First PostedOct 2023
TodayJul 2026
First PostedOct 19, 2023
Enrollment StartSep 1, 2014
Primary CompletionDec 1, 2022
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 2.7 years ago