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Cardiovascular Outcomes Study of Naltrexone SR/Bupropion SR in Overweight and Obese Subjects With Cardiovascular Risk Factors (The Light Study)

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ClinicalTrials.gov Identifier: NCT01601704
Recruitment Status : Terminated
First Posted : May 18, 2012
Results First Posted : February 27, 2017
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):
Orexigen Therapeutics, Inc

Tracking Information
First Submitted Date  ICMJE May 14, 2012
First Posted Date  ICMJE May 18, 2012
Results First Submitted Date  ICMJE December 11, 2016
Results First Posted Date  ICMJE February 27, 2017
Last Update Posted Date February 27, 2017
Study Start Date  ICMJE June 2012
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2017)
Percentage of Participants With a Confirmed Occurrence of Major Adverse Cardiovascular Event (MACE) [ Time Frame: Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 16, 2012)
Time from treatment period randomization to the first confirmed occurrence of MACE [ Time Frame: Day 1 to first confirmed occurrence, assessed up to 4 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2017)
  • Percentage of Participants With a Confirmed Occurrence of Cardiovascular Death, Nonfatal Myocardial Infarction, Nonfatal Stroke, or Nonfatal Unstable Angina Requiring Hospitalization [ Time Frame: Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up ]
    Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures.
  • Percentage of Participants With a Confirmed Occurrence of Cardiovascular Death (Including Fatal Myocardial Infarction, Fatal Stroke) [ Time Frame: Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up ]
    Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures.
  • Percentage of Participants With a Confirmed Occurrence of Myocardial Infarction (Nonfatal or Fatal) [ Time Frame: Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up ]
    Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures.
  • Percentage of Participants With a Confirmed Occurrence of Stroke (Nonfatal or Fatal) [ Time Frame: Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up ]
    Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2012)
  • Time from treatment period randomization to the first confirmed occurrence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or nonfatal unstable angina requiring hospitalization [ Time Frame: Day 1 to first confirmed occurrence, assessed up to 4 years ]
  • Time from treatment period randomization to the confirmed occurrence of cardiovascular death (including fatal myocardial infarction, fatal stroke) [ Time Frame: Day 1 to first confirmed occurrence, assessed up to 4 years ]
  • Time from treatment period randomization to the first confirmed occurrence of myocardial infarction (nonfatal or fatal) [ Time Frame: Day 1 to first confirmed occurrence, assessed up to 4 years ]
  • Time from treatment period randomization to the first confirmed occurrence of stroke (nonfatal or fatal) [ Time Frame: Day 1 to first confirmed occurrence, assessed up to 4 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cardiovascular Outcomes Study of Naltrexone SR/Bupropion SR in Overweight and Obese Subjects With Cardiovascular Risk Factors (The Light Study)
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Occurrence of Major Adverse Cardiovascular Events (MACE) in Overweight and Obese Subjects With Cardiovascular Risk Factors Receiving Naltrexone SR/Bupropion SR
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Overweight
Intervention  ICMJE
  • Drug: NB32
    Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.
    Other Name: CONTRAVE
  • Drug: PBO
    Placebo. Administered in addition to the weight management program.
  • Behavioral: 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.
    Other Name: WeightMate (Tm)
Study Arms  ICMJE
  • Experimental: NB32
    Interventions:
    • Drug: NB32
    • Behavioral: Weight Management Program
  • Placebo Comparator: PBO
    Interventions:
    • Drug: PBO
    • Behavioral: Weight Management Program
Publications * Nissen SE, Wolski KE, Prcela L, Wadden T, Buse JB, Bakris G, Perez A, Smith SR. Effect of Naltrexone-Bupropion on Major Adverse Cardiovascular Events in Overweight and Obese Patients With Cardiovascular Risk Factors: A Randomized Clinical Trial. JAMA. 2016 Mar 8;315(10):990-1004. doi: 10.1001/jama.2016.1558.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 7, 2016)
8910
Original Estimated Enrollment  ICMJE
 (submitted: May 16, 2012)
9880
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. ≥50 years of age (women) or ≥45 years of age (men)
  2. Body mass index (BMI) ≥27 kg/m2 and ≤50 kg/m2
  3. Waist circumference ≥88 cm (women) or ≥102 cm (men)
  4. At increased risk of adverse cardiovascular outcomes:

    • Cardiovascular disease (confirmed diagnosis or at high likelihood of cardiovascular disease) with at least one of the following:

      • History of documented myocardial infarction >3 months prior to screening
      • History of coronary revascularization
      • History of carotid or peripheral revascularization
      • Angina with ischemic changes (resting ECG), ECG changes on a graded exercise test (GXT), or positive cardiac imaging study
      • Ankle brachial index <0.9 (by simple palpation) within prior 2 years
      • ≥50% stenosis of a coronary, carotid, or lower extremity artery within prior 2 years

AND/OR

  • Type 2 diabetes mellitus with at least 2 of the following:

    • Hypertension (controlled with or without pharmacotherapy at <145/95 mm Hg)
    • Dyslipidemia requiring pharmacotherapy
    • Documented low HDL cholesterol (<50 mg/dL in women or <40 mg/dL in men) within prior 12 months
    • Current tobacco smoker

Exclusion Criteria:

  1. Myocardial infarction within 3 months prior to screening
  2. Angina pectoris Grade III or IV as per the Canadian Cardiovascular Society grading scheme
  3. Clinical history of cerebrovascular disease (stroke)
  4. History of tachyarrhythmia other than sinus tachycardia
  5. Planned bariatric surgery, cardiac surgery, or coronary angioplasty
  6. History of seizures (including febrile seizures), cranial trauma, or other conditions that predispose the subject to seizures
  7. History of mania or current diagnosis of active psychosis, active bulimia or anorexia nervosa (binge eating disorder is not exclusionary)
  8. Any condition with life expectancy anticipated to be less than 4 years (e.g., congestive heart failure NYHA Class 3 or 4)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01601704
Other Study ID Numbers  ICMJE NB-CVOT
The Light Study ( Other Identifier: Takeda )
U1111-1162-4981 ( Registry Identifier: WHO )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Orexigen Therapeutics, Inc
Study Sponsor  ICMJE Orexigen Therapeutics, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Clinical Science Takeda
PRS Account Orexigen Therapeutics, Inc
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP