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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01601704
First received: May 14, 2012
Last updated: February 26, 2015
Last verified: February 2015
  Purpose

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.


Condition Intervention Phase
Obesity
Overweight
Drug: NB32
Drug: PBO
Behavioral: Weight Management Program
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 10400
Study Start Date: June 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NB32 Drug: NB32
Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.
Other Name: CONTRAVE
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)
Placebo Comparator: PBO 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)

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01601704

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States
Dothan, Alabama, United States
Mobile, Alabama, United States
Scottsboro, Alabama, United States
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Chandler, Arizona, United States
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Green Bay, Wisconsin, United States
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Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Clinical Science Takeda
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01601704     History of Changes
Other Study ID Numbers: NB-CVOT, The Light Study, U1111-1162-4981
Study First Received: May 14, 2012
Last Updated: February 26, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Takeda:
Body Weight
Bupropion
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Heart Diseases
Metabolic Diseases
Narcotic Antagonists
Naltrexone
Nutrition Disorders
Obesity
Overnutrition
Overweight

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms
Bupropion
Naltrexone
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Narcotic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 03, 2015