Effect of Naltrexone Hydrochloride ER and Bupropion Hydrochloride ER Combination (Contrave®/Mysim… (NCT06098079) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Effect of Naltrexone Hydrochloride ER and Bupropion Hydrochloride ER Combination (Contrave®/Mysimba®) on Major Adverse Cardiovascular Events (MACE)
United States8,600 participantsStarted 2024-01-03
Plain-language summary
A randomized, double-blinded, placebo controlled study intended to capture cardiovascular outcomes during real-world use of naltrexone/bupropion (NB).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patient age ≥18 years at screening
✓. Able to understand the key components of the study, as described in the written informed consent document, and willing and able to provide written informed consent
✓. BMI ≥30 kg/m2 (obese) or ≥27 kg/m2 (overweight) in the presence of at least 1 weight-related comorbidity (eg, hypertension, type 2 diabetes mellitus, or dyslipidemia)
✓. At increased risk of adverse cardiovascular outcomes:
✓. Patients who have completed a washout (2-weeks or 5 half-lives, whichever is longer) of the prohibited concomitant medication(s) at screening
✓. Subject willing to comply with daily completion of an eDiary using a mobile smartphone application
Exclusion criteria
✕. Using prescription medications, other than Contrave/Mysimba, or surgical or medical device interventions for weight loss
✕. History of MI or stroke within 90 days prior to screening
✕. Uncontrolled hypertension, defined as systolic BP ≥160 mmHg and/or \>100 mmHg diastolic BP on the average of 3 seated BP measurements after the patient has been at rest for at least 5 minutes
✕. Meets any of the following criteria:
✕. Seizure disorders or history of seizures, not including subjects with a history of pediatric febrile seizures
What they're measuring
1
Occurrence of Cardiovascular Death
Timeframe: Treatment initiation through 1 year following treatment termination.
2
Occurrence of Non-fatal Myocardial Infarction (MI)
Timeframe: Treatment initiation through 1 year following treatment termination.
3
Occurrence of Non-fatal Stroke
Timeframe: Treatment initiation through 1 year following treatment termination.
. Use of other bupropion-containing products (including but not limited to Wellbutrin, Wellbutrin SR, Wellbutrin XL, and Aplenzin)
✕. Active anorexia nervosa or bulimia
✕. Chronic opioid or opiate agonist (eg, methadone) or partial agonists (eg, buprenorphine) use, or acute opioid withdrawal or has a positive urine drug result for opioids at screening