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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT01601704
First received: May 14, 2012
Last updated: April 26, 2016
Last verified: April 2016

May 14, 2012
April 26, 2016
June 2012
August 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01601704 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Cardiovascular Outcomes Study of Naltrexone SR/Bupropion SR in Overweight and Obese Subjects With Cardiovascular Risk Factors (The Light Study)
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Obesity
  • Overweight
  • 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)
  • Experimental: NB32
    Interventions:
    • Drug: NB32
    • Behavioral: Weight Management Program
  • Placebo Comparator: PBO
    Interventions:
    • Drug: PBO
    • Behavioral: Weight Management Program
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.
 
Terminated
8910
August 2015
August 2015   (final data collection date for primary outcome measure)

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)
Both
45 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01601704
NB-CVOT, The Light Study, U1111-1162-4981
Yes
Not Provided
Not Provided
Orexigen Therapeutics, Inc
Orexigen Therapeutics, Inc
Not Provided
Study Director: Medical Director Clinical Science Takeda
Orexigen Therapeutics, Inc
April 2016

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