Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
67 participants
INTERVENTIONAL
2016-01-31
2016-06-30
Brief Summary
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Detailed Description
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The study will enroll approximately 8800 patients. After a 2-week lead-in period evaluating tolerance to NB (participants were randomly assigned in a 1:1 ratio to 1 week of NB \[1 tablet per day\] followed by 1 week of placebo \[1 tablet per day\] or 1 week of placebo followed by 1 week of NB), participants will be randomly assigned to one of two treatment groups in a 1:1 ratio, which will remain undisclosed to the patient, study site personnel, and investigator/study physician during the study (unless there is an urgent medical need):
* Naltrexone HCl 8 mg/bupropion 90 mg extended release combination tablets
* Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient
All participants will be asked to take tablet(s) in the AM and PM at the same time each day throughout the study.
This multi-center trial will be conducted in the United States. The overall time to participate in this study is up to 6 years. Participants will make multiple visits to the clinic, and will be contacted by telephone 30 days after last dose of study drug for a follow-up assessment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Lead-In: Naltrexone/Bupropion + Placebo
Naltrexone hydrochloride (HCl) 8 mg/bupropion HCl 90 mg extended release (ER) combination tablets, orally, once daily for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, once daily for 1 week. Participants who tolerate the naltrexone/bupropion treatment and comply with taking the study medication during the Lead-In Period will be randomized to the Double-Blind Treatment Period.
Naltrexone HCl/Bupropion HCl ER
Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets
Placebo
Naltrexone HCl/bupropion HCl placebo-matching tablets
Lead-In: Placebo + Naltrexone/Bupropion
Naltrexone/bupropion placebo-matching tablets, orally, once daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, once daily, for 1 week. Participants who tolerate the naltrexone/bupropion treatment and comply with taking the study medication during the Lead-In Period will be randomized to the Double-Blind Treatment Period.
Naltrexone HCl/Bupropion HCl ER
Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets
Placebo
Naltrexone HCl/bupropion HCl placebo-matching tablets
Naltrexone/Bupropion
Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet, in the morning (AM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet in the AM and one in the evening (PM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.
Naltrexone HCl/Bupropion HCl ER
Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets
Placebo
Naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.
Placebo
Naltrexone HCl/bupropion HCl placebo-matching tablets
Interventions
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Naltrexone HCl/Bupropion HCl ER
Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets
Placebo
Naltrexone HCl/bupropion HCl placebo-matching tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2\. Participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
3\. Has body mass index (BMI) ≥27.0 kg/m\^2 at Screening. 4. Is male or female and aged ≥18 years at Screening. 5. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent through 12 weeks after the last dose of study medication.
6\. Participant meets at least 1 the following categories of cardiovascular (CV) disease (a-c):
1. Documented coronary artery disease (at least 1 of the following 2 criteria must be satisfied):
1. A documented history of myocardial infarction (MI) occurring greater than 3 months prior to Screening.
2. History of coronary revascularization with at least 1 of the following:
1. Coronary artery bypass graft surgery occurring greater than 3 months prior to Screening.
2. Percutaneous coronary intervention (PCI) occurring greater than 3 months prior to Screening.
2. Documented peripheral arterial disease (at least 1 of the following 3 criteria must be satisfied):
1. Current intermittent claudication or verified ischemic ulcer(s) together with documented ankle-brachial index ≤0.85.
2. History of previous vascular intervention for intermittent claudication or resting limb ischemia greater than 3 months prior to Screening (example: amputation for arterial disease, peripheral bypass, or history of angioplasty/stenting).
3. History of symptomatic carotid artery disease (requiring revascularization with carotid endarterectomy or stenting) greater than 3 months prior to Screening or ≥50% stenosis on at least one carotid artery documented by duplex ultrasonography, magnetic resonance angiography, computed tomographic angiography, or catheter-based contrast angiography.
3. Documented cerebrovascular disease (at least 1 of the following 2 criteria must be satisfied):
1. A history of transient ischemic attack confirmed by a neurologist greater than 3 months prior to Screening and clinically and neurologically stable at Screening.
2. A history of ischemic stroke (with a Modified Rankin Scale Score ≤3) greater than 3 months prior to Screening and clinically and neurologically stable at Screening.
Exclusion Criteria
2. Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
3. Has had an MI or unstable angina within 3 months of Screening.
4. Has planned bariatric surgery, cardiac surgery, coronary revascularization, or peripheral artery revascularization.
5. Has history of bariatric surgery (eg, Roux-en-Y gastric bypass, duodenal switch, or sleeve gastrectomy).
6. Has had a procedure for weight loss other than bariatric surgery (eg, gastric banding or any other devices that maybe used in obesity treatment) within past 12 months prior to Screening.
7. Has a history of hypersensitivity or allergies to any component of naltrexone hydrochloride (HCl) and bupropion HCl extended release combination (NB) or excipients.
8. Has a history of cancer that has been in remission for \<5 years prior to Screening. A history of basal cell carcinoma or Stage 1 squamous cell carcinoma of the skin is allowed.
9. Is hemodynamically unstable, including severe heart failure (New York Heart Association Class IV) at Screening.
10. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 2 years prior to Screening.
11. Has been randomized into a previous NB (Contrave) study or has been exposed to commercially available NB (Contrave) for any period of time prior to Screening.
12. Is taking excluded medications within 28 days of Screening.
13. Has uncontrolled hypertension defined by systolic blood pressure (SBP) ≥160 mm Hg and/or ≥100 mm Hg diastolic blood pressure (DBP) on the average of two seated blood pressure measurements after being at rest at least 5 minutes, confirmed on 2 separate days during the Screening Period.
14. Has severe renal impairment defined by estimated glomerular filtration rate (eGFR) \<30 ml/min/1.73 m\^2 based on the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) at Screening.
15. Has a clinical history of liver failure.
16. Has a known infection with human immunodeficiency virus that is being treated with ritonavir, lopinavir or efavirenz.
17. Has known acute hepatitis at Screening.
18. Has chronic use of opioids, defined as longer than 3 months prior to Screening.
19. Has a positive drug screen for cocaine, methamphetamine, methadone, opiates, oxycodone, phencyclidine, and propoxyphene at Screening. A positive screen for amphetamines, barbiturates, benzodiazepines, and cannabinoids is exclusionary if abuse or dependence is suspected.
20. Has a history of seizures (including febrile seizures), cranial trauma, or other conditions that predispose the participant to seizures.
21. Has a history of mania, history of or current diagnosis of bipolar disorder or current diagnosis of active psychosis, active bulimia or anorexia nervosa (binge eating disorder is not exclusionary).
22. Is at risk for suicide attempts based on the judgment of the investigator.
23. If female, the participant is pregnant (confirmed by laboratory testing at screening) or lactating or intending to become pregnant from signing the informed consent through 12 weeks after last dose of study medication; or intending to donate ova during such time period.
24. Has a history of severe ischemic stroke (with a Modified Rankin Scale Score ≥4).
25. Has any major illness or condition that, in the investigator's opinion, prohibits the participant from participating in the study or meeting the planned visit schedule.
26. Is unable to understand verbal or written English or any other language, for which a certified translation of the approved informed consent is available.
1. Participant takes \<75% or \>125% of the Lead-in study medication.
2. Participant discontinues study medication treatment or has a known major adverse cardiovascular events (MACE) reported by investigator during the Double-Blind Lead-in Period.
18 Years
ALL
No
Sponsors
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Orexigen Therapeutics, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director Clinical Science
Role: STUDY_DIRECTOR
Takeda
Locations
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Alexander City, Alabama, United States
Auburn, Alabama, United States
Birmingham, Alabama, United States
Huntsville, Alabama, United States
Campe Verde, Arizona, United States
Chandler, Arizona, United States
Cottonwood, Arizona, United States
Fountain Hills, Arizona, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Fayetteville, Arkansas, United States
Jonesboro, Arkansas, United States
Little Rock, Arkansas, United States
Arvin, California, United States
Bakersfield, California, United States
Chino, California, United States
Downey, California, United States
El Cajon, California, United States
Los Alamitos, California, United States
Los Angeles, California, United States
Pomona, California, United States
Sacramento, California, United States
Santa Ana, California, United States
Santa Monica, California, United States
Denver, Colorado, United States
New London, Connecticut, United States
Stamford, Connecticut, United States
Trumbull, Connecticut, United States
Waterbury, Connecticut, United States
Wilmington, Delaware, United States
Boca Raton, Florida, United States
Bradenton, Florida, United States
Brandon, Florida, United States
Brooksville, Florida, United States
Coral Springs, Florida, United States
Cutler Bay, Florida, United States
Daytona Beach, Florida, United States
Hialeah, Florida, United States
Inverness, Florida, United States
Jacksonville Beach, Florida, United States
Lake Worth, Florida, United States
Largo, Florida, United States
Miami Lakes, Florida, United States
Orlando, Florida, United States
Palm Harbor, Florida, United States
Pembroke Pines, Florida, United States
Ponte Vedra Beach, Florida, United States
Sarasota, Florida, United States
Stuart, Florida, United States
Atlanta, Georgia, United States
Duluth, Georgia, United States
Savannah, Georgia, United States
Honolulu, Hawaii, United States
Pocatello, Idaho, United States
Blue Island, Illinois, United States
Chicago, Illinois, United States
Evanston, Illinois, United States
Gurnee, Illinois, United States
Rock Island, Illinois, United States
Evansville, Indiana, United States
Topeka, Kansas, United States
Louisville, Kentucky, United States
Owensboro, Kentucky, United States
Baton Rouge, Louisiana, United States
Bossier City, Louisiana, United States
Lake Charles, Louisiana, United States
Shreveport, Louisiana, United States
Baltimore, Maryland, United States
Catonsville, Maryland, United States
Bay City, Michigan, United States
Saginaw, Michigan, United States
Port Gibson, Mississippi, United States
Hazelwood, Missouri, United States
Great Falls, Montana, United States
Las Vegas, Nevada, United States
Linden, New Jersey, United States
Moorestown, New Jersey, United States
Albuquerque, New Mexico, United States
Endwell, New York, United States
Great Neck, New York, United States
Mineola, New York, United States
New York, New York, United States
Saratoga Springs, New York, United States
Staten Island, New York, United States
Asheville, North Carolina, United States
Cary, North Carolina, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Greenville, North Carolina, United States
Hickory, North Carolina, United States
Morehead City, North Carolina, United States
Raleigh, North Carolina, United States
Rocky Mount, North Carolina, United States
Salisbury, North Carolina, United States
Winston-Salem, North Carolina, United States
Canton, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Perrysburg, Ohio, United States
Sandusky, Ohio, United States
Willoughby, Ohio, United States
Altoona, Pennsylvania, United States
Camp Hill, Pennsylvania, United States
Doylestown, Pennsylvania, United States
Lansdale, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Smithfield, Pennsylvania, United States
Yardley, Pennsylvania, United States
Charleston, South Carolina, United States
Moncks Corner, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Simpsonville, South Carolina, United States
Bristol, Tennessee, United States
Jackson, Tennessee, United States
Knoxville, Tennessee, United States
Memphis, Tennessee, United States
Arlington, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Katy, Texas, United States
Kingwood, Texas, United States
Palestine, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
Bountiful, Utah, United States
Murray, Utah, United States
Ogden, Utah, United States
Orem, Utah, United States
South Ogden, Utah, United States
West Jordan, Utah, United States
West, Utah, United States
Richmond, Virginia, United States
Roanoke, Virginia, United States
Virginia Beach, Virginia, United States
Port Orchard, Washington, United States
Charleston, West Virginia, United States
Kenosha, Wisconsin, United States
Countries
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Other Identifiers
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U1111-1169-1350
Identifier Type: REGISTRY
Identifier Source: secondary_id
NaltrexBuprop-4001
Identifier Type: -
Identifier Source: org_study_id
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