The purpose of this study is to determine the effects of NB relative to placebo on major adverse cardiovascular events (MACE) such as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke in overweight and obese subjects who are at a higher risk of having these events because they have diabetes and/or other cardiovascular risk factors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
8,910
Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.
Placebo. Administered in addition to the weight management program.
A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools.
Percentage of Participants With a Confirmed Occurrence of Major Adverse Cardiovascular Event (MACE)
The primary endpoint is the time from randomization to the first confirmed occurrence of any event within the primary MACE composite (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke). Due to early termination of the study, pre-planned 50% interim analysis is considered the primary analysis for outcome measures. The pre-planned 50% interim analysis was conducted when 50% of the total planned MACE were observed.
Time frame: Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up
Percentage of Participants With a Confirmed Occurrence of Cardiovascular Death, Nonfatal Myocardial Infarction, Nonfatal Stroke, or Nonfatal Unstable Angina Requiring Hospitalization
Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures.
Time frame: Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up
Percentage of Participants With a Confirmed Occurrence of Cardiovascular Death (Including Fatal Myocardial Infarction, Fatal Stroke)
Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures.
Time frame: Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up
Percentage of Participants With a Confirmed Occurrence of Myocardial Infarction (Nonfatal or Fatal)
Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures.
Time frame: Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Dothan, Alabama, United States
Unnamed facility
Mobile, Alabama, United States
Unnamed facility
Scottsboro, Alabama, United States
Unnamed facility
Chandler, Arizona, United States
Unnamed facility
Mesa, Arizona, United States
Unnamed facility
Peoria, Arizona, United States
Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
Scottsdale, Arizona, United States
Unnamed facility
Tucson, Arizona, United States
...and 214 more locations
Percentage of Participants With a Confirmed Occurrence of Stroke (Nonfatal or Fatal)
Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures.
Time frame: Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up