Real-World Evidence on the Cardiovascular Safety of CONTRAVE® in the United States (U.S.)
NCT06090461 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 31889
Last updated 2025-06-25
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.
Conditions
Sponsors & Collaborators
-
Currax Pharmaceuticals
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-09-30
- Primary Completion
- 2022-12-31
- Completion
- 2022-12-31
Countries
- United States
Study Locations
More Related Trials
-
Method-of-Use Study Assessing the Effect of Naltrexone Sustained Release (SR)/ Bupropion SR on Body Weight and Cardiovascular Risk Factors in Overweight and Obese Subjects
NCT01764386 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of the Safety and Efficacy of Two Doses of Naltrexone SR/Bupropion SR and Placebo in Overweight and Obese Subjects
NCT00532779 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Naltrexone SR/ Bupropion SR in Overweight and Obese Subjects Who Are Nicotine-Dependent
NCT00563563 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and PK Study of BICX104 With or Without Bupropion Compared to Vivitrol
NCT07269873 ·Status: RECRUITING ·Phase: PHASE1
-
Study to Evaluate the Effect of Naltrexone and Bupropion Extended-Release Combination on Cardiac Repolarization in Healthy Participants
NCT02735603 ·Status: COMPLETED ·Phase: PHASE1
-
Extended Release Naltrexone for Opioid-Dependent Youth
NCT01843023 ·Status: COMPLETED ·Phase: PHASE4
-
Naltrexone/Bupropion (Mysimba) to Optimize Weight Outcomes After Obesity Surgery
NCT04399395 ·Status: WITHDRAWN ·Phase: PHASE4
-
Study to Evaluate the Effect of Naltrexone and Bupropion Combination on the Pharmacokinetics of Metformin in Healthy Participants
NCT02745912 ·Status: COMPLETED ·Phase: PHASE1
-
Bioequivalency Study of Buprenorphine Hydrochloride 8 mg Tablet Under Fasted Conditions
NCT00992095 ·Status: COMPLETED ·Phase: NA
-
Phase 1 Naltrexone-Bupropion-Methamphetamine Interaction Study
NCT01359930 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Naltrexone SR/ Bupropion SR in Overweight or Obese Subjects With Major Depression
NCT00624858 ·Status: COMPLETED ·Phase: PHASE2
-
Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment
NCT02032433 ·Status: COMPLETED ·Phase: PHASE4
-
Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension)
NCT02537574 ·Status: COMPLETED ·Phase: PHASE3
-
Pharmacokinetic and Safety Study of Naltrexone Release From Subcutaneous BICX104 Pellets Compared to Vivitrol Injections
NCT04828694 ·Status: COMPLETED ·Phase: PHASE1
-
Effectiveness of Buprenorphine/Naloxone
NCT02882412 ·Status: UNKNOWN
-
Weight Loss Study: Genetics and Response to Naltrexone/Bupropion
NCT05919797 ·Status: RECRUITING ·Phase: PHASE4
-
Suvorexant for Opioid/Stimulant Co-use
NCT05546515 ·Status: COMPLETED ·Phase: PHASE2
-
Fentanyl Buccal Tablets Versus Immediate Release Oxycodone for Breakthrough Pain in Patients With Chronic Pain
NCT00813488 ·Status: COMPLETED ·Phase: PHASE3
-
Study for Naltrexone on the Abuse Potential of Methylphenidate
NCT03769064 ·Status: COMPLETED ·Phase: PHASE1
-
Blockade Efficacy of Buprenorphine/Naloxone For Opioid Dependence
NCT00134888 ·Status: COMPLETED ·Phase: NA
-
Biomarkers of Injectable Extended Release Naltrexone Treatment
NCT02324725 ·Status: COMPLETED ·Phase: PHASE4
-
Extended-Release Naltrexone and Monthly Extended-Release Buprenorphine for Cocaine Use Disorder (CURB-2)
NCT05262270 ·Status: COMPLETED ·Phase: PHASE2
-
Buprenorphine/Naloxone for Opiate-Dependence Treatment - 1
NCT00015028 ·Status: COMPLETED ·Phase: PHASE2
-
Suvorexant as an Adjunct to Buprenorphine in Persons Who Use Fentanyl
NCT05145764 ·Status: RECRUITING ·Phase: PHASE2
-
Buprenorphine Combination Tablet Feasibility - 1
NCT00000298 ·Status: COMPLETED ·Phase: PHASE2