Real-World Evidence on the Cardiovascular Safety of CONTRAVE® in the United States (U.S.)

Part of paid clinical trials in Brentwood, Tennessee.

Sponsor
Currax Pharmaceuticals
Study ID
NCT06090461
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Sep 30, 2014
Status verified
Jun 2025
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022

Study Design

Enrollment
31,889 participants (actual)

Arms

  • Arm: Contrave/Mysimba
    A fixed-dose combination of 8 milligrams (mg) of naltrexone hydrochloride (HCl) (an opioid receptor antagonist), and 90 mg of bupropion HCl (a selective neuronal re-uptake inhibitor of noradrenaline and dopamine), delivered through extended-release oral tablets.
  • Arm: Lorcaserin
    A total of one 10 mg tablet administered orally twice daily; or one 20 mg tablet administered orally once daily. Lorcaserin was included as an active comparator to reduce bias.
  • Arm: Naltrexone and Bupropion (N&B)
    N\&B concomitant use, ultimately as a proxy for initiation, was defined as a record for naltrexone followed by initiation of bupropion, or bupropion followed by initiation of naltrexone, within 15 days of each other.

Primary Outcome Measure

The Incidence of Major Adverse Cardiovascular Events (MACE) Between Initiators of CONTRAVE®/MYSIMBA® or N&B and Initiators of Lorcaserin. [ Time Frame: Up to 113 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Currax PharmaceuticalsBrentwoodTennessee37027-

Find similar trials in Brentwood, TN

By condition
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By specialty
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By research site
Currax Pharmaceuticals· Brentwood, TN

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