RECRUITING

Effect of Naltrexone Hydrochloride ER and Bupropion Hydrochloride ER Combination (Contrave®/Mysimba®) on Major Adverse Cardiovascular Events (MACE)

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Conditions

Obesity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A randomized, double-blinded, placebo controlled study intended to capture cardiovascular outcomes during real-world use of naltrexone/bupropion (NB).

Official Title

A Phase IV Study to Assess the Effect of Naltrexone Hydrochloride Extended Release (ER) and Bupropion Hydrochloride ER Combination (Contrave®/Mysimba®) on the Occurrence of Major Adverse Cardiovascular Events

Quick Facts

Study Start:2024-01-03
Study Completion:2029-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06098079

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patient age ≥18 years at screening
  2. 2. 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
  3. 3. 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)
  4. 4. At increased risk of adverse cardiovascular outcomes:
  5. * History of documented MI \>90 days prior to screening
  6. * History of coronary revascularization (ie, coronary artery bypass graft surgery, stent placement, percutaneous transluminal coronary angioplasty, or laser atherectomy) \>90 days prior to screening
  7. * History of carotid or peripheral revascularization (ie, carotid endarterectomy, lower extremity atherosclerotic disease atherectomy, repair of abdominal aorta aneurysm, femoral or popliteal bypass) \>90 days prior to screening
  8. * Angina with ischemic changes (resting echocardiogram (ECHO), ECG changes on a graded exercise test (GXT), or positive cardiac imaging study)
  9. * Ankle brachial index \<0.9 (by simple palpation) within prior 2 years or
  10. * Hypertension (controlled with or without pharmacotherapy at \<145/95 mmHg)
  11. * Dyslipidemia requiring pharmacotherapy
  12. * Documented low HDL cholesterol (\<50 mg/dL in women or \<40 mg/dL in men) within the prior 12 months
  13. * Current tobacco smoker
  14. 5. Patients who have completed a washout (2-weeks or 5 half-lives, whichever is longer) of the prohibited concomitant medication(s) at screening
  15. 6. Subject willing to comply with daily completion of an eDiary using a mobile smartphone application
  1. 1. Using prescription medications, other than Contrave/Mysimba, or surgical or medical device interventions for weight loss
  2. 2. History of MI or stroke within 90 days prior to screening
  3. 3. 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
  4. 4. Meets any of the following criteria:
  5. * Confirmed end-stage renal disease (ie, a degree of kidney failure severe enough to require dialysis or kidney transplantation for survival characterized by a severe reduction in glomerular filtration rate \[\<15 mL/minute/1.73 m2\] and other manifestations including increased serum creatinine),
  6. * Severe hepatic impairment (Child-Pugh score 10 to 15 \[Class C\]),
  7. * Hemodynamic instability, including patients with severe heart failure (New York Heart Association Class IV)
  8. 5. Seizure disorders or history of seizures, not including subjects with a history of pediatric febrile seizures
  9. 6. Use of other bupropion-containing products (including but not limited to Wellbutrin, Wellbutrin SR, Wellbutrin XL, and Aplenzin)
  10. 7. Active anorexia nervosa or bulimia
  11. 8. 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
  12. 9. Undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs
  13. 10. Concomitant administration of MAOIs. This also includes use of reversible MAOIs, such as linezolid or intravenous methylene blue. At least 14 days should elapse between discontinuation of MAOIs and initiation of treatment with Contrave/Mysimba.
  14. 11. Subject has any disease or condition, or use of any pharmacological agent to treat the disease/condition, that, in the opinion of the investigator, would contraindicate study participation
  15. 12. Known allergy to bupropion, naltrexone, or any other component of Contrave/Mysimba
  16. 13. Pregnant or nursing
  17. 14. Known life-threatening arrythmias, including Brugada syndrome
  18. 15. Participation in any other concurrent investigational trial

Contacts and Locations

Study Contact

Elizabeth Debnam, B.S.
CONTACT
919.805.2157
SM_INFORMUS_NB-CVOT3_External@syneoshealth.com

Study Locations (Sites)

Accel Research Sites Network
Birmingham, Alabama, 35216
United States
Cullman Clinical Trials
Cullman, Alabama, 35055
United States
AMR Mobile
Mobile, Alabama, 36608
United States
Velocity Clinical Research, Mobile
Mobile, Alabama, 36608
United States
Desert Clinical Research
Mesa, Arizona, 85213
United States
Velocity Clinical Research, Phoenix
Phoenix, Arizona, 85006
United States
CCT Research
Tempe, Arizona, 85283
United States
Velocity Clinical Research, Gardena
Anderson, California, 90247
United States
Velocity Clinical Research
Chula Vista, California, 91911
United States
Velocity Clinical Research, Huntington Park
Huntington Park, California, 90255
United States
Velocity Clinical Research
La Mesa, California, 91942
United States
Velocity Clinical Research
Los Angeles, California, 90057
United States
Velocity Clinical Research
San Bernardino, California, 92408
United States
Velocity Clinical Research at Coastal Heart Medical Group
Santa Ana, California, 92704
United States
Velocity Clinical Research of Santa Ana
Santa Ana, California, 92704
United States
Velocity Clinical Research
Van Nuys, California, 91405
United States
Velocity Clinical Research, Denver
Englewood, Colorado, 80110
United States
LMG Research
Coral Gables, Florida, 33134
United States
Accel Research Sites Network - Edgewater
Edgewater, Florida, 32132
United States
Velocity Clinical Research (New Smyrna Beach)
Edgewater, Florida, 32132
United States
Conveinent Medical Research
Hialeah, Florida, 33013
United States
Miami Beach Clinical Research
Miami Beach, Florida, 33141
United States
Medical Research Center Westchester
Miami, Florida, 33165
United States
Century Research
Miami, Florida, 33173
United States
Janus Clinical Research
Miami, Florida, 33186
United States
Innovia Research Center
Miramar, Florida, 33027
United States
Best Choice Medical and Research Services
Pembroke Pines, Florida, 33024
United States
Advanced Clinical Research Atlanta
Atlanta, Georgia, 30309
United States
Clincept Clinical Research
Columbus, Georgia, 31904
United States
Accel Research Sites (ARSN) - Neurostudies
Decatur, Georgia, 30030
United States
Velocity Clinical Research, Savannah
Savannah, Georgia, 31406
United States
NextStage Clinical Research-Chicago
Glen Ellyn, Illinois, 60137
United States
JAELEX Research
Round Lake Beach, Illinois, 60073
United States
Velocity Clinical Research
Valparaiso, Indiana, 46383
United States
Velocity Clinical Research
Sioux City, Iowa, 51106
United States
AMR - El Dorado
El Dorado, Kansas, 67042
United States
Velocity Clinical Research, Kansas City
Kansas City, Kansas, 66210
United States
AMR Wichita West
Wichita, Kansas, 67205
United States
AMR Wichita East
Wichita, Kansas, 67207
United States
Wichita Surgical Specialists
Wichita, Kansas, 67214
United States
Velocity Clinical Research
Baton Rouge, Louisiana, 70809
United States
Velocity Clinical Research
Covington, Louisiana, 70433
United States
Velocity Clinical Research
Lafayette, Louisiana, 70508
United States
AMR New Orleans
New Orleans, Louisiana, 70119
United States
Velocity Clinical Research
New Orleans, Louisiana, 70119
United States
Velocity Clinical Research
Slidell, Louisiana, 70458
United States
Regenerative Orthopedics and Sports Medicine- NextStage Clinical Research
North Bethesda, Maryland, 20852
United States
Advanced Primary Care & Geriatrics/CCT Research
Rockville, Maryland, 20850
United States
Velocity Clinical Research, Rockville
Rockville, Maryland, 20854
United States
Activmed Practices and Research, Inc
Methuen, Massachusetts, 01844
United States
Dearborn Cardiology
Dearborn, Michigan, 48126
United States
Velocity Clinical Research
Gulfport, Mississippi, 39503
United States
Clay Platte Family Medicine
Kansas City, Missouri, 64151
United States
St. Louis Medical Professionals/CCT Research
Saint Louis, Missouri, 63119
United States
Velocity Clinical Research, Grand Island
Grand Island, Nebraska, 68803
United States
Velocity Clinical Research at Pioneer Heart Institute
Lincoln, Nebraska, 68506
United States
Velocity Clinical Research
Lincoln, Nebraska, 68510
United States
Velocity Clinical Research, Norfolk
Norfolk, Nebraska, 68701
United States
Meridian Clinical Research - Velocity
Omaha, Nebraska, 68134
United States
Midwest Regional Health Services
Omaha, Nebraska, 68144
United States
Healor Primary Care/CCT Research
Las Vegas, Nevada, 89102
United States
Santa Rosa Urgent Care Primary Care/CCT Research
Las Vegas, Nevada, 89119
United States
ActivMed Practices and Research
Portsmouth, New Hampshire, 03801
United States
Velocity Clinical Research
Albuquerque, New Mexico, 87107
United States
Axces Research Group
Santa Fe, New Mexico, 87505
United States
Velocity Clinical Research
Binghamton, New York, 13905
United States
Velocity Clinical Research
Vestal, New York, 13850
United States
Velocity Clinical Research, Durham
Durham, North Carolina, 27701
United States
Velocity Clinical Research
Beachwood, Ohio, 44122
United States
Velocity Clinical Research, Mt. Auburn
Cincinnati, Ohio, 45219
United States
Velocity Clinical Research, Cincinnati
Cincinnati, Ohio, 45242
United States
Velocity Clinical Research
Cincinnati, Ohio, 45246
United States
NextStage Clinical Research
Tulsa, Oklahoma, 74136
United States
Velocity Clinical Research, Grants Pass
Grants Pass, Oregon, 97527
United States
Velocity Clinical Research, Medford
Medford, Oregon, 97504
United States
Mercado Medical Practice/CCT Research
Philadelphia, Pennsylvania, 19111
United States
Velocity Clinical Research (Providence)
East Greenwich, Rhode Island, 02818
United States
Velocity Clinical Research
Anderson, South Carolina, 29621
United States
Velocity Clinical Research
Charleston, South Carolina, 29414
United States
Velocity Clinical Research
Columbia, South Carolina, 29204
United States
Velocity Clinical Research
Gaffney, South Carolina, 29340
United States
Velocity Clinical Research
Greenville, South Carolina, 29615
United States
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
United States
Velocity Clinical Research, Spartanburg
Spartanburg, South Carolina, 29303
United States
Velocity Clinical Research, Union
Union, South Carolina, 29379
United States
Velocity Clinical Research, Abilene
Abilene, Texas, 79606
United States
Velocity Clinical Research
Austin, Texas, 78759
United States
Advanced Cardiovascular Specialists/NextStage Clinical Research
Beaumont, Texas, 77702
United States
HDH Research
Houston, Texas, 77022
United States
All-American Orthopedics-NextStage Clinical Research
Houston, Texas, 77058
United States
NextStage Clinical Research-Lubbock/SWAT Surgical Associates-NextStage Clinical Research
Lubbock, Texas, 79410
United States
NextStage Clinical Research-Port Arthur/Gulf Coast Cardiology
Port Arthur, Texas, 77642
United States
Waco Cardiology Consultants
Waco, Texas, 76712
United States
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, 84088
United States
Charlottesville Medical Research
Charlottesville, Virginia, 22911
United States
Velocity Clinical Research, Hampton
Hampton, Virginia, 23666
United States
AMR Norfolk
Norfolk, Virginia, 23502
United States
Velocity Clinical Research, Portsmouth
Suffolk, Virginia, 23435
United States
Evergreen Surgical
Eau Claire, Wisconsin, 54701
United States

Collaborators and Investigators

Sponsor: Currax Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-03
Study Completion Date2029-07

Study Record Updates

Study Start Date2024-01-03
Study Completion Date2029-07

Terms related to this study

Additional Relevant MeSH Terms

  • Obesity