Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-25 @ 7:06 PM
Study NCT ID:
NCT01601704
Status:
TERMINATED
Last Update Posted:
2017-02-27
First Post:
2012-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Cardiovascular Outcomes Study of Naltrexone SR/Bupropion SR in Overweight and Obese Subjects With Cardiovascular Risk Factors (The Light Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D044343', 'term': 'Overnutrition'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591595', 'term': 'bupropion hydrochloride, naltrexone hydrochoride drug combination'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'MedInfo@Orexigen.com', 'phone': '858-875-8600', 'title': 'Global Head of Development', 'organization': 'Orexigen Therapeutics, Inc.'}, 'certainAgreement': {'otherDetails': "If not already published by Sponsor as part of a multi-center publication, 24 months after conclusion, abandonment or termination of the study or notification that there will be no such multi-center publication, PI may publish the results for PI's study center individually. Prior to such publication, PI must provide Sponsor with at least 90 days to review and comment on the proposed publication. Sponsor may delay publication for up to an additional 6-month period to file for patent protection.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was terminated early. Outcome measures data is based on the 50% interim analysis, designated as the primary analysis. Safety data is based on all available data at the time of database lock, which occurred after the 50% interim analysis.'}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent serious adverse events and treatment-emergent adverse events leading to study medication discontinuation are defined as those events with onset coincident with treatment period randomization starting at Visit 3 (Day 1) and through end of study or 30 days after discontinuation of study medication (whichever one is earlier).', 'description': 'Safety data is based on all available data at the time of database lock, which occurred after the pre-planned 50% interim analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'NB32', 'description': "NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.\n\nWeight 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.", 'otherNumAtRisk': 4455, 'otherNumAffected': 1157, 'seriousNumAtRisk': 4455, 'seriousNumAffected': 463}, {'id': 'EG001', 'title': 'Placebo', 'description': "Administered in addition to the weight management program.\n\nWeight 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.", 'otherNumAtRisk': 4450, 'otherNumAffected': 282, 'seriousNumAtRisk': 4450, 'seriousNumAffected': 386}], 'otherEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cardiac discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cardiac flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hearing impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blepharospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 27, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bowel movement irregularity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Coeliac disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 129, 'numAffected': 129}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 35, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diverticulum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Epigastric discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Faecal incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Frequent bowel movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastrointestinal hypermotility', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypoaesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lip swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 346, 'numAffected': 346}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oesophageal rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Retching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 89, 'numAffected': 89}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vomiting projectile', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Drug intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Feeling abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Feeling jittery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Feeling of body temperature change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Generalised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 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'numAtRisk': 4455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pulmonary thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Subcutaneous emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastrectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hip surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Accelerated hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Iliac artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Subclavian artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4455, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4450, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With a Confirmed Occurrence of Major Adverse Cardiovascular Event (MACE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4455', 'groupId': 'OG000'}, {'value': '4450', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NB32', 'description': "NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.\n\nWeight 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."}, {'id': 'OG001', 'title': 'Placebo', 'description': "Administered in addition to the weight management program.\n\nWeight 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."}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99.7', 'paramValue': '0.88', 'ciLowerLimit': '0.57', 'ciUpperLimit': '1.34', 'estimateComment': 'Hazard ratio is based on CPH model with treatment as a factor.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'At the pre-planned 50% interim analysis, a non-inferiority analysis was conducted based on the estimated hazard ratio (NB32/Placebo) for the time to the first confirmed occurrence of MACE. The upper-bound of the 99.7% confidence interval for the hazard ratio was compared to 1.4, the non-inferiority margin.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population is defined as subjects who undergo randomization into the Treatment Period (TP) and are dispensed study medication. Treatment refers to the treatment assigned during TP randomization rather than the actual treatment received. ITT population is the primary analysis population for the primary and secondary endpoints.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Confirmed Occurrence of Cardiovascular Death, Nonfatal Myocardial Infarction, Nonfatal Stroke, or Nonfatal Unstable Angina Requiring Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4455', 'groupId': 'OG000'}, {'value': '4450', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NB32', 'description': "NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.\n\nWeight 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."}, {'id': 'OG001', 'title': 'Placebo', 'description': "Administered in addition to the weight management program.\n\nWeight 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."}], 'classes': [{'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99.7', 'paramValue': '0.93', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.33', 'estimateComment': 'Hazard ratio is based on CPH model with treatment as a factor.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up', 'description': 'Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population is defined as subjects who undergo randomization into the Treatment Period (TP) and are dispensed study medication. Treatment refers to the treatment assigned during TP randomization rather than the actual treatment received. ITT population is the primary analysis population for the primary and secondary endpoints.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Confirmed Occurrence of Cardiovascular Death (Including Fatal Myocardial Infarction, Fatal Stroke)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4455', 'groupId': 'OG000'}, {'value': '4450', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NB32', 'description': "NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.\n\nWeight 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."}, {'id': 'OG001', 'title': 'Placebo', 'description': "Administered in addition to the weight management program.\n\nWeight 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."}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99.7', 'paramValue': '0.50', 'ciLowerLimit': '0.21', 'ciUpperLimit': '1.19', 'estimateComment': 'Hazard ratio is based on CPH model with treatment as a factor.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up', 'description': 'Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population is defined as subjects who undergo randomization into the Treatment Period (TP) and are dispensed study medication. Treatment refers to the treatment assigned during TP randomization rather than the actual treatment received. ITT population is the primary analysis population for the primary and secondary endpoints.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Confirmed Occurrence of Myocardial Infarction (Nonfatal or Fatal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4455', 'groupId': 'OG000'}, {'value': '4450', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NB32', 'description': "NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.\n\nWeight 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."}, {'id': 'OG001', 'title': 'Placebo', 'description': "Administered in addition to the weight management program.\n\nWeight 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."}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99.7', 'paramValue': '0.96', 'ciLowerLimit': '0.55', 'ciUpperLimit': '1.67', 'estimateComment': 'Hazard ratio is based on CPH model with treatment as a factor.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up', 'description': 'Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population is defined as subjects who undergo randomization into the Treatment Period (TP) and are dispensed study medication. Treatment refers to the treatment assigned during TP randomization rather than the actual treatment received. ITT population is the primary analysis population for the primary and secondary endpoints.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Confirmed Occurrence of Stroke (Nonfatal or Fatal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4455', 'groupId': 'OG000'}, {'value': '4450', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NB32', 'description': "NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.\n\nWeight 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."}, {'id': 'OG001', 'title': 'Placebo', 'description': "Administered in addition to the weight management program.\n\nWeight 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."}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99.7', 'paramValue': '1.04', 'ciLowerLimit': '0.43', 'ciUpperLimit': '2.55', 'estimateComment': 'Hazard ratio is based on CPH model with treatment as a factor.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up', 'description': 'Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population is defined as subjects who undergo randomization into the Treatment Period (TP) and are dispensed study medication. Treatment refers to the treatment assigned during TP randomization rather than the actual treatment received. ITT population is the primary analysis population for the primary and secondary endpoints.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NB32', 'description': "NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.\n\nWeight 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."}, {'id': 'FG001', 'title': 'Placebo', 'description': "Administered in addition to the weight management program.\n\nWeight 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."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Represents number of participants randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4456'}, {'groupId': 'FG001', 'numSubjects': '4454'}]}, {'type': 'Treated', 'comment': 'Represents number of participants included in the ITT analysis', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4455'}, {'groupId': 'FG001', 'numSubjects': '4450'}]}, {'type': 'COMPLETED', 'comment': 'Completed indicates treated participants. Represents number of participants in the ITT analysis.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4455'}, {'groupId': 'FG001', 'numSubjects': '4450'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Randomized but not dispensed study med', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4455', 'groupId': 'BG000'}, {'value': '4450', 'groupId': 'BG001'}, {'value': '8905', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'NB32', 'description': "NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.\n\nWeight 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."}, {'id': 'BG001', 'title': 'Placebo', 'description': "Administered in addition to the weight management program.\n\nWeight 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."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4455', 'groupId': 'BG000'}, {'value': '4450', 'groupId': 'BG001'}, {'value': '8905', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2973', 'groupId': 'BG000'}, {'value': '3053', 'groupId': 'BG001'}, {'value': '6026', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1482', 'groupId': 'BG000'}, {'value': '1397', 'groupId': 'BG001'}, {'value': '2879', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4455', 'groupId': 'BG000'}, {'value': '4450', 'groupId': 'BG001'}, {'value': '8905', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '61.1', 'spread': '7.27', 'groupId': 'BG000'}, {'value': '60.9', 'spread': '7.38', 'groupId': 'BG001'}, {'value': '61.0', 'spread': '7.33', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4455', 'groupId': 'BG000'}, {'value': '4450', 'groupId': 'BG001'}, {'value': '8905', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2437', 'groupId': 'BG000'}, {'value': '2419', 'groupId': 'BG001'}, {'value': '4856', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2018', 'groupId': 'BG000'}, {'value': '2031', 'groupId': 'BG001'}, {'value': '4049', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4455', 'groupId': 'BG000'}, {'value': '4450', 'groupId': 'BG001'}, {'value': '8905', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '279', 'groupId': 'BG000'}, {'value': '291', 'groupId': 'BG001'}, {'value': '570', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4174', 'groupId': 'BG000'}, {'value': '4156', 'groupId': 'BG001'}, {'value': '8330', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4455', 'groupId': 'BG000'}, {'value': '4450', 'groupId': 'BG001'}, {'value': '8905', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '656', 'groupId': 'BG000'}, {'value': '648', 'groupId': 'BG001'}, {'value': '1304', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '3738', 'groupId': 'BG000'}, {'value': '3698', 'groupId': 'BG001'}, {'value': '7436', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': 'NA', 'comment': 'Selection of multiple race categories was not permissible by the participants. Participants advised to select the most appropriate category.', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'Selection of multiple race categories was not permissible by the participants. Participants advised to select the most appropriate category.', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4455', 'groupId': 'BG000'}, {'value': '4450', 'groupId': 'BG001'}, {'value': '8905', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4455', 'groupId': 'BG000'}, {'value': '4450', 'groupId': 'BG001'}, {'value': '8905', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4455', 'groupId': 'BG000'}, {'value': '4450', 'groupId': 'BG001'}, {'value': '8905', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '105.6', 'spread': '19.09', 'groupId': 'BG000'}, {'value': '106.3', 'spread': '19.18', 'groupId': 'BG001'}, {'value': '106.0', 'spread': '19.14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4452', 'groupId': 'BG000'}, {'value': '4450', 'groupId': 'BG001'}, {'value': '8902', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '37.2', 'spread': '5.26', 'groupId': 'BG000'}, {'value': '37.4', 'spread': '5.44', 'groupId': 'BG001'}, {'value': '37.3', 'spread': '5.35', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'BMI was calculated at the site. Data are missing for 3 participants for whom the site did not calculate BMI, although weight and height were measured.'}, {'title': 'Cardiovascular (CV) risk group', 'classes': [{'title': 'CV disease without T2DM (type 2 diabetes mellitus)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4455', 'groupId': 'BG000'}, {'value': '4450', 'groupId': 'BG001'}, {'value': '8905', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '670', 'groupId': 'BG000'}, {'value': '646', 'groupId': 'BG001'}, {'value': '1316', 'groupId': 'BG002'}]}]}, {'title': 'CV disease with T2DM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4455', 'groupId': 'BG000'}, {'value': '4450', 'groupId': 'BG001'}, {'value': '8905', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '745', 'groupId': 'BG000'}, {'value': '801', 'groupId': 'BG001'}, {'value': '1546', 'groupId': 'BG002'}]}]}, {'title': 'T2DM without CV disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4455', 'groupId': 'BG000'}, {'value': '4450', 'groupId': 'BG001'}, {'value': '8905', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3039', 'groupId': 'BG000'}, {'value': '3002', 'groupId': 'BG001'}, {'value': '6041', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hypertension', 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4455', 'groupId': 'BG000'}, {'value': '4450', 'groupId': 'BG001'}, {'value': '8905', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4162', 'groupId': 'BG000'}, {'value': '4117', 'groupId': 'BG001'}, {'value': '8279', 'groupId': 'BG002'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4455', 'groupId': 'BG000'}, {'value': '4450', 'groupId': 'BG001'}, {'value': '8905', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '293', 'groupId': 'BG000'}, {'value': '333', 'groupId': 'BG001'}, {'value': '626', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Dyslipidemia', 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4455', 'groupId': 'BG000'}, {'value': '4450', 'groupId': 'BG001'}, {'value': '8905', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4100', 'groupId': 'BG000'}, {'value': '4070', 'groupId': 'BG001'}, {'value': '8170', 'groupId': 'BG002'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4455', 'groupId': 'BG000'}, {'value': '4450', 'groupId': 'BG001'}, {'value': '8905', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '355', 'groupId': 'BG000'}, {'value': '380', 'groupId': 'BG001'}, {'value': '735', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of Depression', 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4455', 'groupId': 'BG000'}, {'value': '4450', 'groupId': 'BG001'}, {'value': '8905', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1031', 'groupId': 'BG000'}, {'value': '995', 'groupId': 'BG001'}, {'value': '2026', 'groupId': 'BG002'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4455', 'groupId': 'BG000'}, {'value': '4450', 'groupId': 'BG001'}, {'value': '8905', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3424', 'groupId': 'BG000'}, {'value': '3455', 'groupId': 'BG001'}, {'value': '6879', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Antidepressant Medication Use', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4455', 'groupId': 'BG000'}, {'value': '4450', 'groupId': 'BG001'}, {'value': '8905', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1042', 'groupId': 'BG000'}, {'value': '1015', 'groupId': 'BG001'}, {'value': '2057', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8910}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-24', 'studyFirstSubmitDate': '2012-05-14', 'resultsFirstSubmitDate': '2016-12-11', 'studyFirstSubmitQcDate': '2012-05-16', 'lastUpdatePostDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-24', 'studyFirstPostDateStruct': {'date': '2012-05-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With a Confirmed Occurrence of Major Adverse Cardiovascular Event (MACE)', 'timeFrame': 'Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With a Confirmed Occurrence of Cardiovascular Death, Nonfatal Myocardial Infarction, Nonfatal Stroke, or Nonfatal Unstable Angina Requiring Hospitalization', 'timeFrame': 'Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up', 'description': 'Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures.'}, {'measure': 'Percentage of Participants With a Confirmed Occurrence of Cardiovascular Death (Including Fatal Myocardial Infarction, Fatal Stroke)', 'timeFrame': 'Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up', 'description': 'Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures.'}, {'measure': 'Percentage of Participants With a Confirmed Occurrence of Myocardial Infarction (Nonfatal or Fatal)', 'timeFrame': 'Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up', 'description': 'Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures.'}, {'measure': 'Percentage of Participants With a Confirmed Occurrence of Stroke (Nonfatal or Fatal)', 'timeFrame': 'Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up', 'description': 'Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['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'], 'conditions': ['Obesity', 'Overweight']}, 'referencesModule': {'references': [{'pmid': '26954408', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ≥50 years of age (women) or ≥45 years of age (men)\n2. Body mass index (BMI) ≥27 kg/m2 and ≤50 kg/m2\n3. Waist circumference ≥88 cm (women) or ≥102 cm (men)\n4. At increased risk of adverse cardiovascular outcomes:\n\n * Cardiovascular disease (confirmed diagnosis or at high likelihood of cardiovascular disease) with at least one of the following:\n\n * History of documented myocardial infarction \\>3 months prior to screening\n * History of coronary revascularization\n * History of carotid or peripheral revascularization\n * Angina with ischemic changes (resting ECG), ECG changes on a graded exercise test (GXT), or positive cardiac imaging study\n * Ankle brachial index \\<0.9 (by simple palpation) within prior 2 years\n * ≥50% stenosis of a coronary, carotid, or lower extremity artery within prior 2 years\n\nAND/OR\n\n* Type 2 diabetes mellitus with at least 2 of the following:\n\n * Hypertension (controlled with or without pharmacotherapy at \\<145/95 mm Hg)\n * Dyslipidemia requiring pharmacotherapy\n * Documented low HDL cholesterol (\\<50 mg/dL in women or \\<40 mg/dL in men) within prior 12 months\n * Current tobacco smoker\n\nExclusion Criteria:\n\n1. Myocardial infarction within 3 months prior to screening\n2. Angina pectoris Grade III or IV as per the Canadian Cardiovascular Society grading scheme\n3. Clinical history of cerebrovascular disease (stroke)\n4. History of tachyarrhythmia other than sinus tachycardia\n5. Planned bariatric surgery, cardiac surgery, or coronary angioplasty\n6. History of seizures (including febrile seizures), cranial trauma, or other conditions that predispose the subject to seizures\n7. History of mania or current diagnosis of active psychosis, active bulimia or anorexia nervosa (binge eating disorder is not exclusionary)\n8. Any condition with life expectancy anticipated to be less than 4 years (e.g., congestive heart failure NYHA Class 3 or 4)'}, 'identificationModule': {'nctId': 'NCT01601704', 'briefTitle': 'Cardiovascular Outcomes Study of Naltrexone SR/Bupropion SR in Overweight and Obese Subjects With Cardiovascular Risk Factors (The Light Study)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Orexigen Therapeutics, Inc'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'NB-CVOT'}, 'secondaryIdInfos': [{'id': 'The Light Study', 'type': 'OTHER', 'domain': 'Takeda'}, {'id': 'U1111-1162-4981', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NB32', 'interventionNames': ['Drug: NB32', 'Behavioral: Weight Management Program']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PBO', 'interventionNames': ['Drug: PBO', 'Behavioral: Weight Management Program']}], 'interventions': [{'name': 'NB32', 'type': 'DRUG', 'otherNames': ['CONTRAVE'], 'description': 'Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.', 'armGroupLabels': ['NB32']}, {'name': 'PBO', 'type': 'DRUG', 'description': 'Placebo. Administered in addition to the weight management program.', 'armGroupLabels': ['PBO']}, {'name': 'Weight Management Program', 'type': 'BEHAVIORAL', 'otherNames': ['WeightMate (Tm)'], 'description': "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.", 'armGroupLabels': ['NB32', 'PBO']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'city': 'Scottsboro', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 34.67231, 'lon': -86.03415}}, {'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Tuscson', 'state': 'Arizona', 'country': 'United States'}, {'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'city': 'Carmichael', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.61713, 'lon': -121.32828}}, {'city': 'Escondido', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'city': 'Fresno', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'city': 'Harbor City', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.79002, 'lon': -118.29785}}, {'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'city': 'Lomita', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.79224, 'lon': -118.31507}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Paramount', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.88946, 'lon': -118.15979}}, {'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.14778, 'lon': 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