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

February 24, 2017 updated by: Orexigen Therapeutics, Inc

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8910

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
      • Dothan, Alabama, United States
      • Mobile, Alabama, United States
      • Scottsboro, Alabama, United States
    • Arizona
      • Chandler, Arizona, United States
      • Mesa, Arizona, United States
      • Peoria, Arizona, United States
      • Phoenix, Arizona, United States
      • Scottsdale, Arizona, United States
      • Tucson, Arizona, United States
      • Tuscson, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Anaheim, California, United States
      • Carmichael, California, United States
      • Escondido, California, United States
      • Fresno, California, United States
      • Harbor City, California, United States
      • Huntington Beach, California, United States
      • La Jolla, California, United States
      • Lomita, California, United States
      • Los Angeles, California, United States
      • Paramount, California, United States
      • Pasadena, California, United States
      • Riverside, California, United States
      • Sacramento, California, United States
      • Santa Rosa, California, United States
      • Spring Valley, California, United States
      • Thousand Oaks, California, United States
      • Torrance, California, United States
      • West Hills, California, United States
    • Colorado
      • Colorado Springs, Colorado, United States
      • Denver, Colorado, United States
      • Golden, Colorado, United States
      • Wheat Ridge, Colorado, United States
    • Connecticut
      • Norwalk, Connecticut, United States
      • Stamford, Connecticut, United States
    • Delaware
      • Wilmington, Delaware, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Boynton Beach, Florida, United States
      • Brooksville, Florida, United States
      • Clearwater, Florida, United States
      • Deland, Florida, United States
      • Delray Beach, Florida, United States
      • Gainesville, Florida, United States
      • Jacksonville, Florida, United States
      • Jacksonville Beach, Florida, United States
      • Melbourne, Florida, United States
      • Miami, Florida, United States
      • New Port Richey, Florida, United States
      • New Smyrna Beach, Florida, United States
      • Oakland Park, Florida, United States
      • Orlando, Florida, United States
      • Palm Harbor, Florida, United States
      • Pembroke Pines, Florida, United States
      • Pensacola, Florida, United States
      • Pinellas Park, Florida, United States
      • Saint Petersburg, Florida, United States
      • Vero beach, Florida, United States
      • Wellington, Florida, United States
      • Winter Haven, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Austell, Georgia, United States
      • Columbus, Georgia, United States
      • Lawrenceville, Georgia, United States
      • Riverdale, Georgia, United States
      • Savannah, Georgia, United States
      • Stockbridge, Georgia, United States
    • Hawaii
      • Honolulu, Hawaii, United States
    • Idaho
      • Meridian, Idaho, United States
    • Illinois
      • Chicago, Illinois, United States
      • Gurnee, Illinois, United States
      • Melrose Park, Illinois, United States
    • Indiana
      • Bloomington, Indiana, United States
      • Brownsburg, Indiana, United States
      • Elwood, Indiana, United States
      • Evansville, Indiana, United States
      • Hammond, Indiana, United States
      • South Bend, Indiana, United States
      • Valparaiso, Indiana, United States
    • Iowa
      • Ames, Iowa, United States
      • Council Bluffs, Iowa, United States
      • Des Moines, Iowa, United States
      • West Des Moines, Iowa, United States
    • Kansas
      • Overland Park, Kansas, United States
      • Wichita, Kansas, United States
    • Kentucky
      • Crestview Hills, Kentucky, United States
      • Louisville, Kentucky, United States
      • Mount Sterling, Kentucky, United States
    • Louisiana
      • Alexandria, Louisiana, United States
      • Baton Rouge, Louisiana, United States
      • Monroe, Louisiana, United States
      • Natchitoches, Louisiana, United States
    • Maine
      • Auburn, Maine, United States
      • Bangor, Maine, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Columbia, Maryland, United States
      • Elkridge, Maryland, United States
      • Lutherville, Maryland, United States
      • Salisbury, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
      • Brockton, Massachusetts, United States
      • Fall River, Massachusetts, United States
      • Haverhill, Massachusetts, United States
      • Methuen, Massachusetts, United States
    • Michigan
      • Bingham Farms, Michigan, United States
      • Dearbon, Michigan, United States
      • Kalamazoo, Michigan, United States
      • Midland, Michigan, United States
      • Saginaw, Michigan, United States
      • Southfield, Michigan, United States
      • Stevensville, Michigan, United States
    • Minnesota
      • Edina, Minnesota, United States
      • Rochester, Minnesota, United States
    • Mississippi
      • Jackson, Mississippi, United States
      • Olive Branch, Mississippi, United States
      • Tupelo, Mississippi, United States
    • Missouri
      • Saint Louis, Missouri, United States
    • Montana
      • Butte, Montana, United States
      • Missoula, Montana, United States
    • Nebraska
      • Fremont, Nebraska, United States
      • Grand Island, Nebraska, United States
      • Omaha, Nebraska, United States
    • Nevada
      • Henderson, Nevada, United States
      • Las Vegas, Nevada, United States
      • Reno, Nevada, United States
      • Sparks, Nevada, United States
    • New Jersey
      • Belvidere, New Jersey, United States
      • Edison, New Jersey, United States
      • Elizabeth, New Jersey, United States
      • Elmer, New Jersey, United States
      • Linden, New Jersey, United States
      • Ridgewood, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Bronx, New York, United States
      • Endwell, New York, United States
      • New Hyde Park, New York, United States
      • New York, New York, United States
      • Staten Island, New York, United States
      • Syracuse, New York, United States
      • Williamsville, New York, United States
    • North Carolina
      • Cary, North Carolina, United States
      • Charlotte, North Carolina, United States
      • Durham, North Carolina, United States
      • Elizabeth City, North Carolina, United States
      • Greensboro, North Carolina, United States
      • Greenville, North Carolina, United States
      • Hickory, North Carolina, United States
      • Morganton, North Carolina, United States
      • Raleigh, North Carolina, United States
      • Salisbury, North Carolina, United States
      • Wilmington, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Akron, Ohio, United States
      • Beachwood, Ohio, United States
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
      • Delaware, Ohio, United States
      • Kettering, Ohio, United States
      • Marion, Ohio, United States
      • Mentor, Ohio, United States
      • Willoughby Hills, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Medford, Oregon, United States
      • Portland, Oregon, United States
    • Pennsylvania
      • Altoona, Pennsylvania, United States
      • Bensalem, Pennsylvania, United States
      • Danville, Pennsylvania, United States
      • Duncansville, Pennsylvania, United States
      • Ephrata, Pennsylvania, United States
      • Jersey Shore, Pennsylvania, United States
      • Lancaster, Pennsylvania, United States
      • Lansdale, Pennsylvania, United States
      • Norristown, Pennsylvania, United States
      • Scottdale, Pennsylvania, United States
      • Sellersville, Pennsylvania, United States
      • State College, Pennsylvania, United States
      • West Reading, Pennsylvania, United States
      • Wilkes-Barre, Pennsylvania, United States
    • South Carolina
      • Anderson, South Carolina, United States
      • Charleston, South Carolina, United States
      • Columbia, South Carolina, United States
      • Greenville, South Carolina, United States
      • Greer, South Carolina, United States
      • Hodges, South Carolina, United States
      • Laurens, South Carolina, United States
      • Mount Pleasant, South Carolina, United States
    • South Dakota
      • Rapid City, South Dakota, United States
    • Tennessee
      • Bristol, Tennessee, United States
      • Chattanooga, Tennessee, United States
      • Germantown, Tennessee, United States
      • Jackson, Tennessee, United States
      • Kingsport, Tennessee, United States
      • Knoxville, Tennessee, United States
      • Memphis, Tennessee, United States
    • Texas
      • Beaumont, Texas, United States
      • Corpus Christi, Texas, United States
      • Dallas, Texas, United States
      • Houston, Texas, United States
      • Hurst, Texas, United States
      • Lake Jackson, Texas, United States
      • McKinney, Texas, United States
      • San Antonio, Texas, United States
      • Schertz, Texas, United States
      • Tomball, Texas, United States
      • Waco, Texas, United States
    • Utah
      • Bountiful, Utah, United States
      • Draper, Utah, United States
      • Murray, Utah, United States
      • Ogden, Utah, United States
      • Orem, Utah, United States
      • Salt Lake City, Utah, United States
      • West Jordan, Utah, United States
    • Virginia
      • Alexandria, Virginia, United States
      • Norfolk, Virginia, United States
      • Richmond, Virginia, United States
      • Winchester, Virginia, United States
    • Washington
      • Seattle, Washington, United States
      • Spokane, Washington, United States
      • Tacoma, Washington, United States
      • Walla Walla, Washington, United States
    • Wisconsin
      • Green Bay, Wisconsin, United States
      • Kenosha, Wisconsin, United States
      • Madison, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NB32
Drug: NB32
Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.
Other Names:
  • 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 Names:
  • WeightMate (Tm)
Placebo Comparator: PBO
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 Names:
  • WeightMate (Tm)
Drug: PBO
Placebo. Administered in addition to the weight management program.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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)
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.
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)
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.
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 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.
Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Orexigen Therapeutics, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NB-CVOT
  • The Light Study (Other Identifier: Takeda)
  • U1111-1162-4981 (Registry Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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