Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06090461
Status:
COMPLETED
Last Update Posted:
2023-10-19
First Post:
2023-10-12
Brief Title:
Real-World Evidence on the Cardiovascular Safety of CONTRAVE in the United States US
Sponsor:
Currax Pharmaceuticals
Organization:
Currax Pharmaceuticals
Study Overview
Official Title:
A Non-Interventional Study to Generate Real-World Evidence on the Cardiovascular Safety of CONTRAVE in the United States US
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HOA
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 US 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 NB in usual clinical practice
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 reduce potential confounding
The cohorts for all study objectives will be drawn from a large electronic health records EHR data source representing a geographically diverse patient population The data will include diagnoses procedures medications prescribed and administered clinical measures biometric and laboratory values and observations derived from clinical notes A subset of the population will have linked adjudicated claims data available to support sensitivity analyses
The studys main objective is to compare the incidence of the primary endpoint MACE between initiators of NB and initiators of lorcaserin The study will also compare the incidence of the secondary endpoint consisting of each component of MACE between initiators of NB and initiators of lorcaserin across the following subgroups Patients with obesity ie most recent BMI measurement 30 kgm2 Patients with a diagnosis of hypertension regardless of BMI Patients with a diagnosis of type 2 diabetes mellitus regardless of BMI Patients with a diagnosis of dyslipidemia regardless of BMI
The studys additional objectives aimed at testing the robustness of the methods are
To assess the comparability of findings from an EHR study to those of a 2018 clinical trial aligning with the RCT DUPLICATE Initiative To quantify differences in cardiovascular safety endpoints between the clinical trial and the results of this EHR study To conduct other sensitivity analyses including a self-controlled case-crossover analysis to quantify the potential effect of NB on MACE
The cohorts for all study objectives will be drawn from a large electronic health records EHR data source representing a geographically diverse patient population The data will include diagnoses procedures medications prescribed and administered clinical measures biometric and laboratory values and observations derived from clinical notes A subset of the population will have linked adjudicated claims data available to support sensitivity analyses
The studys main objective is to compare the incidence of the primary endpoint MACE between initiators of NB and initiators of lorcaserin The study will also compare the incidence of the secondary endpoint consisting of each component of MACE between initiators of NB and initiators of lorcaserin across the following subgroups Patients with obesity ie most recent BMI measurement 30 kgm2 Patients with a diagnosis of hypertension regardless of BMI Patients with a diagnosis of type 2 diabetes mellitus regardless of BMI Patients with a diagnosis of dyslipidemia regardless of BMI
The studys additional objectives aimed at testing the robustness of the methods are
To assess the comparability of findings from an EHR study to those of a 2018 clinical trial aligning with the RCT DUPLICATE Initiative To quantify differences in cardiovascular safety endpoints between the clinical trial and the results of this EHR study To conduct other sensitivity analyses including a self-controlled case-crossover analysis to quantify the potential effect of NB on MACE
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None