Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2026-03-03 @ 8:25 PM
Study NCT ID:
NCT03640312
Status:
COMPLETED
Last Update Posted:
2025-01-03
First Post:
2018-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of a Quadruple Ultra-low-dose Treatment for Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C081643', 'term': 'candesartan'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'guhaniyer@wustl.edu', 'phone': '3147479487', 'title': 'Guhan Iyer', 'organization': 'Washington University in St. Louis'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'description': "Same as clinicaltrials.gov definition.\n\nA known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.", 'eventGroups': [{'id': 'EG000', 'title': 'QUARTET LDQT', 'description': 'Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 20, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Candesartan', 'description': 'Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 14, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vision blurred', 'notes': '2 Total events:\n\n1. Severity: Mild. Outcome: Ongoing at study exit. Relatedness assessment: Unrelated. Investigational product action taken: None. Study arm: Candesartan\n2. Severe, resolved without sequelae, unlikely related, no action taken, LDQT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Palpitations', 'notes': 'Palpitations, mild, resolved without sequelae, possible relatedness, no IP action taken.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Tinnitus', 'notes': 'Ringing in ears, mild, ongoing at study exit, assessed unrelated, no IP action taken.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Eye pruritis', 'notes': 'Itchy eyes, mild, resolved without sequelae, unlikely relatedness, no IP action taken', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diarrhea', 'notes': '5 total events (2 control, 3 LDQT) Diarrhea, mild (5/5), resolved w/o sequelae (4/5) ongoing at study exit (1/5), unlikely (2/5) unrelated (3/5), no IP action taken (4/5) temporarily withdrawn (1/5).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal pain upper', 'notes': '3 total Stomach cramping (1/3) stomach gas/pain (2/3), mild (3/3), resolved without sequelae (2/3) ongoing at study exit (1/3), unrelated (3/3), no IP action taken (1/3) temporarily withdrawn (1/3) permanently discontinued (1/3)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dry Mouth', 'notes': 'mild, resolved without sequelae, unrelated, no IP action taken', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Constipation', 'notes': 'mild, resolved without sequelae, unrelated, no IP action taken', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Throat irritation', 'notes': 'mild, resolved without sequelae, possible relatedness, no IP action taken', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nausea', 'notes': 'Nausea/vomiting, mild, resolved without sequelae, possible relatedness, permanently discontinued', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dry throat', 'notes': 'mild, resolved without sequelae, possible relatedness, temporarily withdrawn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vomiting', 'notes': 'Nausea/Vomiting, mild, resolved without sequelae, unrelated, temporarily withdrawn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Feeling Hot', 'notes': 'Feeling warm, moderate, resolved without sequelae, possible relatedness, permanently discontinued', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Influenza like illness', 'notes': 'Flu-like symptoms, moderate, ongoing at study exit, unrelated, no IP action taken', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Fatigue', 'notes': '4 total mild (4/4), resolved without sequelae (4/4), unrelated (1/4) unlikely (2/4), possible (1/4), no IP action taken (4/4)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Peripheral swelling', 'notes': '4 total Swelling of legs/ankles (2/4) swelling of hands/feet (2/4), mild (4/4), resolved without sequelae (3/4) ongoing at study exit (1/4), unrelated (2/4) possible (2/4), no IP action taken (3/4) permanently discontinued (1/4)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Chest Pain', 'notes': 'mild, resolved without sequelae, unrelated, no IP action taken', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Asthenia', 'notes': 'mild, resolved without sequelae, possible relatedness, temporarily withdrawn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pain', 'notes': 'Body aches, mild, resolved without sequelae, unrelated, temporarily withdrawn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood glucose increased', 'notes': 'Elevated blood sugar, mild, ongoing at study exit, unlikely relatedness, no IP action taken', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Heart rate irregular', 'notes': '5 total irregular/fast heartbeat (5/5), mild (5/5), resolved without sequelae (4/5) ongoing at study exit (1/5), unrelated (2/5) unlikely (2/5) possible (1/5), no IP action taken (3/5) permanently discontinued (2/5)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Back pain', 'notes': 'mild, ongoing at study exit, unlikely relatedness, no IP action taken', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Muscle cramps/spasms', 'notes': '2 total mild (1/2) severe (1/2), resolved without sequelae (2/2), unrelated (1/2) unlikely (1/2), no IP action taken (2/2)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Headache', 'notes': '8 total mild (8/8), resolved without sequelae (7/8) ongoing at study exit (1/8), unrelated (4/8) unlikely (3/8) possible (1/8), no IP action taken (6/8) permanently discontinued (2/8)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dizziness', 'notes': '2 total mild (2/2), resolved without sequelae (2/2), possible relatedness (2/2), no IP action taken (2/2)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vision blurred', 'notes': 'Blurred vision/vision or hearing changes, mild, resolved without sequelae, unlikely relatedness, permanently discontinued', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypoaesthesia', 'notes': 'cold/tingling/numb hands/feet, mild, resolved without sequelae, unrelated, no IP action taken', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Anxiety', 'notes': '3 total mild (3/3), resolved without sequelae (1/3) resolved with sequelae (1/3) ongoing at study exit (1/3), unrelated (2/3) possible (1/3), no IP action taken (3/3)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nasopharyngitis', 'notes': 'Cold symptoms, mild, ongoing at study exit, unrelated, no IP action taken', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cough', 'notes': '3 total mild (3/3), resolved without sequelae (1/3) resolved with sequelae (1/3) ongoing at study exit (1/3), unrelated (2/3) unlikely (1/3), no IP action taken (3/3)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dyspnea', 'notes': '6 total Breathing problems (6/6), mild (5/6) moderate (1/6), resolved without sequelae (3/6) resolved with sequelae (2/6) ongoing at study exit (1/6), unrelated (4/6) unlikely (2/6), no IP action taken (5/6) temporarily withdrawn (1/6)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Respiration Abnormal', 'notes': 'Breathing problem, severe, resolved without sequelae, unlikely relatedness, no IP action taken', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyperhidrosis', 'notes': '2 total Sweating (2/2), mild (2/2), resolved without sequelae (2/2), unrealted (2/2), no IP action taken (1/2) permanently discontinued (1/2)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rash', 'notes': 'Rash, mild, resolved without sequelae, unlikely relatedness, no IP action taken', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dizziness', 'notes': '5 total Feeling faint/lightheadedness/falling (5/5), mild (4/5) moderate (1/5), resolved without sequelae (5/5), unlikely relatedness (2/5) possible (3/5), no IP action taken (5/5)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'Road Traffic Accident', 'notes': 'Motor Vehicle Accident. Severity: Severe. Outcome: Resolved with sequelae. Blinded relatedness assessment: Unrelated. Investigational product action taken: Temporarily Withdrawn. Resulted in hospitalization.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Chest Pain', 'notes': 'Severity: Severe. Outcome: Resolved with Sequelae. Relatedness Assessment: Unrelated. Investigational Product action taken: Temporarily Withdrawn. Resulted in hospitalization.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Mean Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QUARTET LDQT', 'description': 'Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Candesartan', 'description': 'Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.65', 'groupId': 'OG000', 'lowerLimit': '-19.70', 'upperLimit': '-11.60'}, {'value': '-10.87', 'groupId': 'OG001', 'lowerLimit': '-15.24', 'upperLimit': '-6.50'}]}]}], 'analyses': [{'pValue': '0.114', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.78', 'ciLowerLimit': '-10.74', 'ciUpperLimit': '1.18', 'pValueComment': 'Adjusting for baseline systolic blood pressure.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.97', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Difference in Least Squared Means (LSM). Random participant effect, fixed baseline, study arm, and time effects.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 weeks', 'description': 'Mean change (from baseline) in automated office systolic blood pressure adjusted for baseline values.', 'unitOfMeasure': 'mm Hg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.'}, {'type': 'SECONDARY', 'title': 'Mean Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QUARTET LDQT', 'description': 'Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Candesartan', 'description': 'Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '122.37', 'groupId': 'OG000', 'lowerLimit': '118.32', 'upperLimit': '126.42'}, {'value': '127.15', 'groupId': 'OG001', 'lowerLimit': '122.78', 'upperLimit': '131.52'}]}]}], 'analyses': [{'pValue': '0.114', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.78', 'ciLowerLimit': '-10.74', 'ciUpperLimit': '1.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.97', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Adjusted for baseline systolic blood pressure.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': 'Mean automated office systolic blood pressure adjusted for baseline values.', 'unitOfMeasure': 'mm Hg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.'}, {'type': 'SECONDARY', 'title': 'Change in Mean Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QUARTET LDQT', 'description': 'Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Candesartan', 'description': 'Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.60', 'groupId': 'OG000', 'lowerLimit': '-14.16', 'upperLimit': '-9.04'}, {'value': '-6.74', 'groupId': 'OG001', 'lowerLimit': '-9.50', 'upperLimit': '-3.98'}]}]}], 'analyses': [{'pValue': '0.012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.86', 'ciLowerLimit': '-8.62', 'ciUpperLimit': '-1.11', 'pValueComment': 'Adjusted Least Squares Mean.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.87', 'groupDescription': 'Adjusted for baseline diastolic blood pressure.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': 'Mean change (from baseline) in automated office diastolic blood pressure adjusted for baseline values.', 'unitOfMeasure': 'mm Hg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.'}, {'type': 'SECONDARY', 'title': 'Mean Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QUARTET LDQT', 'description': 'Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Candesartan', 'description': 'Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '73.01', 'groupId': 'OG000', 'lowerLimit': '70.46', 'upperLimit': '75.57'}, {'value': '77.88', 'groupId': 'OG001', 'lowerLimit': '75.12', 'upperLimit': '80.64'}]}]}], 'analyses': [{'pValue': '0.012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.86', 'ciLowerLimit': '-8.62', 'ciUpperLimit': '-1.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.87', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': 'Mean automated office diastolic blood pressure adjusted for baseline values.', 'unitOfMeasure': 'mm Hg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With Hypertension Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QUARTET LDQT', 'description': 'Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Candesartan', 'description': 'Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.'}], 'classes': [{'title': '6 weeks', 'categories': [{'measurements': [{'value': '0.6875', 'groupId': 'OG000'}, {'value': '0.3929', 'groupId': 'OG001'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '0.6667', 'groupId': 'OG000'}, {'value': '0.5769', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.077', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.40', 'ciLowerLimit': '0.91', 'ciUpperLimit': '6.35', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Generalized Linear Mixed Model (binomial distribution assumption with logit link).'}], 'paramType': 'NUMBER', 'timeFrame': '6 and 12 weeks', 'description': 'Proportion of patients with hypertension control (percent with SBP \\< 130 mmHg and DBP \\<80 mmHg).', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Requiring Step up Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QUARTET LDQT', 'description': 'Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Candesartan', 'description': 'Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '0.03', 'ciUpperLimit': '0.48', 'groupDescription': 'Logistic regression model adjusting for baseline systolic and diastolic blood pressure.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks', 'description': 'Number of patients requiring step-up treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With Adverse Event Free Hypertension Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QUARTET LDQT', 'description': 'Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Candesartan', 'description': 'Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.710', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.24', 'ciUpperLimit': '2.69', 'groupDescription': 'Generalized linear mixed model adjusting for baseline systolic and diastolic blood pressure. Random participant effects. Fixed baseline systolic, diastolic, study arm, and time effects.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': 'Proportion of patients with adverse event free hypertension control (percent with SBP \\< 130 mmHg and DBP \\<80 mmHg).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.'}, {'type': 'SECONDARY', 'title': 'Medication Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QUARTET LDQT', 'description': 'Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Candesartan', 'description': 'Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.437', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '0.21', 'ciUpperLimit': '1.98', 'groupDescription': 'Logistic regression model adjusting for baseline systolic and diastolic blood pressure.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': 'Medication adherence defined by objective pill counts', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.'}, {'type': 'SECONDARY', 'title': 'Health-related Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QUARTET LDQT', 'description': 'Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Candesartan', 'description': 'Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.'}], 'classes': [{'title': 'Change in Physical Health T score (PROMIS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.28', 'spread': '7.48', 'groupId': 'OG000'}, {'value': '5.99', 'spread': '6.97', 'groupId': 'OG001'}]}]}, {'title': 'Change in Mental Health T score (PROMIS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.86', 'spread': '6.25', 'groupId': 'OG000'}, {'value': '2.76', 'spread': '7.63', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.09', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.45', 'ciLowerLimit': '-7.49', 'ciUpperLimit': '0.59', 'pValueComment': 'Adjusted for baseline T score', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.01', 'groupDescription': 'Statistical test for difference in Physical Health T Score', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.77', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.55', 'ciLowerLimit': '-3.22', 'ciUpperLimit': '4.32', 'pValueComment': 'Adjusted for baseline mental health T score', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.88', 'groupDescription': 'Statistical test for difference in Mental Health T Score', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 weeks', 'description': 'Mean change (from baseline) in health-related quality of life using Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health instrument. PROMIS Global Health is a gauge of general health-care related quality of life. Possible PROMIS Global Physical Health and Global Mental Health scores range from 0-20, with 20 indicating best possible state of health. Raw scores are converted to T-scores to compare to a standardized population. A PROMIS T-score of 50 represents the mean of the population (SD = 10). Higher values here also indicate better health. A positive change in T score, as reported in this outcome measure, would represent an improvement in Global Physical Health or Global Mental Health at 12 weeks compared to baseline.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are available on only 28 participants in the intervention group for the mental health T score.'}, {'type': 'SECONDARY', 'title': 'Change in Mean Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QUARTET LDQT', 'description': 'Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Candesartan', 'description': 'Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.65', 'groupId': 'OG000', 'lowerLimit': '-19.70', 'upperLimit': '-11.60'}, {'value': '-10.87', 'groupId': 'OG001', 'lowerLimit': '-15.24', 'upperLimit': '-6.50'}]}]}], 'analyses': [{'pValue': '0.114', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.78', 'ciLowerLimit': '-10.74', 'ciUpperLimit': '1.182', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.97', 'groupDescription': 'Linear mixed model. Random participant effects. Fixed baseline systolic, study arm, and time effects.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': 'Mean change (from baseline) in automated office systolic blood pressure adjusted for baseline values.', 'unitOfMeasure': 'mm Hg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QUARTET LDQT', 'description': 'Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Candesartan', 'description': 'Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.49', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.04', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': 'Percentage of participants with any Serious Adverse Events (SAE) according to Good Clinical Practice definition: adverse events that result in death, are life threatening, require hospitalization or prolong existing hospitalization, result in persistent disability, result in congenital anomaly or birth defect, or unimportant medical event that requires intervention to prevent any of the above.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Potentially Related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QUARTET LDQT', 'description': 'Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Candesartan', 'description': 'Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.21', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '0.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': 'Percentage of participants with occurrence of any potentially related adverse event (pre-specified as in study procedures). Defined as: At least possibly related to study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Adverse Events of Special Interest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QUARTET LDQT', 'description': 'Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Candesartan', 'description': 'Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.18', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.17', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '0.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': 'Rate of pre-specified adverse events that are known side effects of active ingredients at the participant level.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Change in Serum Potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QUARTET LDQT', 'description': 'Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Candesartan', 'description': 'Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.56', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Mean change (from baseline) in continuous serum potassium.', 'unitOfMeasure': 'mEq/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Change in Serum Sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QUARTET LDQT', 'description': 'Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Candesartan', 'description': 'Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.81', 'spread': '2.00', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '2.66', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.12', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.71', 'ciLowerLimit': '-1.61', 'ciUpperLimit': '0.19', 'pValueComment': 'Linear mixed model. Random participant effects. Fixed baseline systolic, study arm, and time effects.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.45', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Mean change (from baseline) in continuous serum sodium.', 'unitOfMeasure': 'mEq/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Change in Blood Urea Nitrogen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QUARTET LDQT', 'description': 'Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Candesartan', 'description': 'Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.38', 'spread': '4.23', 'groupId': 'OG000'}, {'value': '-0.40', 'spread': '7.11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.94', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-1.84', 'ciUpperLimit': '1.99', 'pValueComment': 'Linear mixed model. Random participant effects. Fixed baseline systolic, study arm, and time effects.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.95', 'estimateComment': 'The model estimated mean differences, adjusted for covariates, will not be equal to the raw mean differences observed.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Mean change (from baseline) in continuous blood urea nitrogen.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Change in Serum Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'QUARTET LDQT', 'description': 'Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Candesartan', 'description': 'Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.55', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.04', 'pValueComment': 'Linear mixed model. Random participant effects. Fixed baseline systolic, study arm, and time effects.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.03', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Mean change in continuous serum creatinine.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'QUARTET LDQT', 'description': 'Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.'}, {'id': 'FG001', 'title': 'Candesartan', 'description': 'Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': '6 Week Follow Up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'recruitmentDetails': '120 were consented and assessed for eligibility. 58 were excluded for not meeting either inclusion or exclusion criteria, declining participation, or not showing up for randomization visits. Thus, these 58 individuals were not randomized, and 62 participants were randomized', 'preAssignmentDetails': 'NA - all enrolled participants were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'QUARTET LDQT', 'description': 'Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.'}, {'id': 'BG001', 'title': 'Candesartan', 'description': 'Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52', 'spread': '12.6', 'groupId': 'BG000'}, {'value': '52', 'spread': '10.5', 'groupId': 'BG001'}, {'value': '52', 'spread': '11.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity', 'categories': [{'title': 'Hispanic', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Black/Sub Saharan African', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'White/Caucasian/Other', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index, kg/m^2', 'classes': [{'categories': [{'measurements': [{'value': '33', 'spread': '6.9', 'groupId': 'BG000'}, {'value': '34', 'spread': '7.9', 'groupId': 'BG001'}, {'value': '34', 'spread': '7.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Heart rate, beats per minute', 'classes': [{'categories': [{'measurements': [{'value': '71.5', 'spread': '10.0', 'groupId': 'BG000'}, {'value': '71.7', 'spread': '11.7', 'groupId': 'BG001'}, {'value': '71.6', 'spread': '10.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'History of diabetes, n (%)', 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of smoking, n (%)', 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of depression, n (%)', 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weekly alcohol use, n (%)', 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Systolic Blood Pressure, mm Hg', 'classes': [{'categories': [{'measurements': [{'value': '137.6', 'spread': '11.8', 'groupId': 'BG000'}, {'value': '138.7', 'spread': '10.8', 'groupId': 'BG001'}, {'value': '138.1', 'spread': '11.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic Blood Pressure, mm Hg', 'classes': [{'categories': [{'measurements': [{'value': '84.3', 'spread': '9.6', 'groupId': 'BG000'}, {'value': '84.3', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '84.3', 'spread': '10.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-20', 'size': 292795, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-05-30T16:14', 'hasProtocol': True}, {'date': '2022-02-09', 'size': 300936, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-05-30T16:14', 'hasProtocol': False}, {'date': '2020-08-13', 'size': 311884, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-08-14T10:08', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-16', 'studyFirstSubmitDate': '2018-08-15', 'resultsFirstSubmitDate': '2023-05-31', 'studyFirstSubmitQcDate': '2018-08-17', 'lastUpdatePostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-20', 'studyFirstPostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Participants With Serious Adverse Events (SAEs)', 'timeFrame': '12 weeks', 'description': 'Percentage of participants with any Serious Adverse Events (SAE) according to Good Clinical Practice definition: adverse events that result in death, are life threatening, require hospitalization or prolong existing hospitalization, result in persistent disability, result in congenital anomaly or birth defect, or unimportant medical event that requires intervention to prevent any of the above.'}, {'measure': 'Percentage of Participants With Potentially Related Adverse Events', 'timeFrame': '12 weeks', 'description': 'Percentage of participants with occurrence of any potentially related adverse event (pre-specified as in study procedures). Defined as: At least possibly related to study drug.'}, {'measure': 'Rate of Adverse Events of Special Interest', 'timeFrame': '12 weeks', 'description': 'Rate of pre-specified adverse events that are known side effects of active ingredients at the participant level.'}, {'measure': 'Mean Change in Serum Potassium', 'timeFrame': '12 weeks', 'description': 'Mean change (from baseline) in continuous serum potassium.'}, {'measure': 'Mean Change in Serum Sodium', 'timeFrame': '12 weeks', 'description': 'Mean change (from baseline) in continuous serum sodium.'}, {'measure': 'Mean Change in Blood Urea Nitrogen', 'timeFrame': '12 weeks', 'description': 'Mean change (from baseline) in continuous blood urea nitrogen.'}, {'measure': 'Mean Change in Serum Creatinine', 'timeFrame': '12 weeks', 'description': 'Mean change in continuous serum creatinine.'}], 'primaryOutcomes': [{'measure': 'Change in Mean Systolic Blood Pressure', 'timeFrame': '12 weeks', 'description': 'Mean change (from baseline) in automated office systolic blood pressure adjusted for baseline values.'}], 'secondaryOutcomes': [{'measure': 'Mean Systolic Blood Pressure', 'timeFrame': '6 weeks', 'description': 'Mean automated office systolic blood pressure adjusted for baseline values.'}, {'measure': 'Change in Mean Diastolic Blood Pressure', 'timeFrame': '6 weeks', 'description': 'Mean change (from baseline) in automated office diastolic blood pressure adjusted for baseline values.'}, {'measure': 'Mean Diastolic Blood Pressure', 'timeFrame': '6 weeks', 'description': 'Mean automated office diastolic blood pressure adjusted for baseline values.'}, {'measure': 'Proportion of Patients With Hypertension Control', 'timeFrame': '6 and 12 weeks', 'description': 'Proportion of patients with hypertension control (percent with SBP \\< 130 mmHg and DBP \\<80 mmHg).'}, {'measure': 'Number of Patients Requiring Step up Treatment', 'timeFrame': '6 weeks', 'description': 'Number of patients requiring step-up treatment.'}, {'measure': 'Proportion of Patients With Adverse Event Free Hypertension Control', 'timeFrame': '12 weeks', 'description': 'Proportion of patients with adverse event free hypertension control (percent with SBP \\< 130 mmHg and DBP \\<80 mmHg).'}, {'measure': 'Medication Adherence', 'timeFrame': '12 weeks', 'description': 'Medication adherence defined by objective pill counts'}, {'measure': 'Health-related Quality of Life', 'timeFrame': '12 weeks', 'description': 'Mean change (from baseline) in health-related quality of life using Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health instrument. PROMIS Global Health is a gauge of general health-care related quality of life. Possible PROMIS Global Physical Health and Global Mental Health scores range from 0-20, with 20 indicating best possible state of health. Raw scores are converted to T-scores to compare to a standardized population. A PROMIS T-score of 50 represents the mean of the population (SD = 10). Higher values here also indicate better health. A positive change in T score, as reported in this outcome measure, would represent an improvement in Global Physical Health or Global Mental Health at 12 weeks compared to baseline.'}, {'measure': 'Change in Mean Systolic Blood Pressure', 'timeFrame': '6 weeks', 'description': 'Mean change (from baseline) in automated office systolic blood pressure adjusted for baseline values.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Blood Pressure'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '38584159', 'type': 'DERIVED', 'citation': 'Huffman MD, Baldridge AS, Lazar D, Abbas H, Mejia J, Flowers FM, Quintana A, Jackson A, Kandula NR, Lloyd-Jones DM, Persell SD, Khan SS, Paparello JJ, Chopra A, Tripathi P, Vu MH, Chow CK, Ciolino JD. Efficacy and safety of a four-drug, quarter-dose treatment for hypertension: the QUARTET USA randomized trial. Hypertens Res. 2024 Jun;47(6):1668-1677. doi: 10.1038/s41440-024-01658-y. Epub 2024 Apr 8.'}, {'pmid': '38156601', 'type': 'DERIVED', 'citation': 'Sanuade OA, Jacobson TA, Quintana A, Flowers FM, Abbasi H, Vu MH, Baldridge AS, Mejia J, Lazar D, Ciolino JD, Huffman MD, Kandula NR. Process Evaluation of a Double-Blind Randomized Controlled Trial to Assess the Efficacy and Safety of a Quadruple Ultra-Low-Dose Treatment for Hypertension Within a Federally Qualified Health Center Network (QUARTET USA). J Am Heart Assoc. 2024 Jan 2;13(1):e032236. doi: 10.1161/JAHA.123.032236. Epub 2023 Dec 29.'}, {'pmid': '36116516', 'type': 'DERIVED', 'citation': 'Baldridge AS, Huffman MD, Lazar D, Abbas H, Flowers FM, Quintana A, Jackson A, Khan SS, Chopra A, Vu M, Tripathi P, Jacobson T, Sanuade OA, Kandula NR, Persell SD, Paparello JJ, Rosul LL, Mejia J, Lloyd-Jones DM, Chow CK, Ciolino JD. Efficacy and safety of a quadruple ultra-low-dose treatment for hypertension (QUARTET USA): Rationale and design for a randomized controlled trial. Am Heart J. 2022 Dec;254:183-193. doi: 10.1016/j.ahj.2022.09.004. Epub 2022 Sep 15.'}]}, 'descriptionModule': {'briefSummary': 'To investigate, in a double-blind randomized controlled trial, whether initiating treatment with ultra-low-dose quadruple-combination therapy ("LDQT") will lower office blood pressure more effectively, and with fewer side effects, compared to initiating standard dose monotherapy as per current guidelines in patients with hypertension.\n\nPrimary hypothesis: A combination pill comprising four types of blood pressure lowering medications, each at one-quarter standard doses, will lower office blood pressure more effectively than initiating patients with standard dose monotherapy as per contemporary clinical practice guideline recommendations.', 'detailedDescription': 'This trial will investigate whether initiating treatment with ultra-low-dose quadruple-combination therapy (LDQT; including candesartan 2 mg, amlodipine 1.25 mg, indapamide 0.625 mg, and bisoprolol 2.5 mg) will lower automated office blood pressure and 24-hour ambulatory blood pressure at 12 weeks more effectively, and with no increase in side effects, compared to initiating standard dose monotherapy (candesartan 8 mg) in adults with raised blood pressure (SBP\\>130 mmHg or DBP\\>80 mmHg) and without cardiovascular disease. Our preliminary data from a short-term (4-week) crossover trial of 18 participants suggest that LDQT lowers office blood pressure by 22/13 mmHg on average compared with placebo with no difference in serious adverse events. Effects on 24-hour ambulatory blood pressure were similar.\n\nThe investigators will perform this phase II, single site, randomized controlled trial in a network of federally qualified health centers in Chicago because this population bears a disproportionate burden of blood pressure related diseases, and the investigators have previously successfully conducted clinical studies in this population.\n\nWhile the investigators hypothesize this intervention will be easily implemented and efficacious for all patients and clinicians, the investigators will explore variation in treatment effect by potential moderating variables, including age, sex, race/ethnicity, and health literacy level. Beyond examining efficacy, the investigators also plan to assess feasibility of implementing this intervention in a clinical setting by simultaneously evaluating implementation outcomes of acceptability, preferences, and lessons of LDQT among patients and clinicians.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults (≥18 years)\n* Spanish or English speaker.\n* Previous documentation within the past 24 months of hypertension or high blood pressure (SBP 130-179 mmHg or DBP 80-109 mmHg) from general practitioner, pharmacist or health care professional (e.g., medical assistant, physician or nurse).\n* Either: 1) Untreated (automated) clinic SBP 140-179 or DBP 90-109 mmHg in the last 12 weeks, OR 2) Monotherapy with clinic SBP 130-159 or DBP 85-99 mmHg in the last 12 weeks.\n* Either: 1) Treatment naïve, OR 2) Currently not on treatment (not take in last 4 weeks), OR 3) Currently taking 1 BP lowering drug (ACE, ARB, CCB, thiazide- or thiazide-like diuretic, BB, MRA, alpha blocker) at any dose.\n* Research grade blood pressure measurement (baseline mean) SBP\\>= 115 mmHg and DBP \\>= 60 mmHg\n\nExclusion Criteria:\n\n* Known contraindication to candesartan, amlodipine, indapamide or bisoprolol.\n* Previous diagnosis of coronary artery disease, stroke, or heart failure.\n* Presence of significant proteinuria (based on 3+ proteinuria via spot urinalysis or \\>300mg/dL of proteinuria based on random urinary albumin-to-creatinine ratio testing of 300 mg/g)\n* Evidence of secondary cause of hypertension e.g., renal artery stenosis; significant renal impairment (eGFR \\<50 ml/min/1.73 m2), raised serum potassium (above lab normal limit of 5.5 mEq/L).\n* Women who are pregnant, breast feeding or of childbearing potential and are not using and do not plan to continue using medically acceptable form of contraception throughout the study (pharmacological or barrier methods).\n* Concomitant illness, physical impairment or mental condition which in the opinion of the study team / primary care physician could interfere with the conduct of the study including outcome assessments.\n* Participation in a concurrent interventional medical investigation or pharmacologic clinical trial. Patients in observational, natural history or epidemiological studies not involving an intervention are eligible.\n* Participant's responsible primary care or other responsible physician believes it is not appropriate for participant to switch current monotherapy.\n* Inability or unwillingness to provide written informed consent.\n* Unable to complete study procedures."}, 'identificationModule': {'nctId': 'NCT03640312', 'acronym': 'QUARTET USA', 'briefTitle': 'Efficacy and Safety of a Quadruple Ultra-low-dose Treatment for Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'A Double Blind Randomized Controlled Trial to Assess the Efficacy and Safety of a Quadruple Ultra-low-dose Treatment for Hypertension (QUARTET USA)', 'orgStudyIdInfo': {'id': '202203097-STU00205834'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QUARTET LDQT', 'description': 'Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.', 'interventionNames': ['Drug: QUARTET LDQT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Candesartan', 'description': 'Patients randomized to the comparison arm will take a once daily 8mg candesartan.', 'interventionNames': ['Drug: Candesartan']}], 'interventions': [{'name': 'QUARTET LDQT', 'type': 'DRUG', 'description': 'Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.', 'armGroupLabels': ['QUARTET LDQT']}, {'name': 'Candesartan', 'type': 'DRUG', 'description': 'Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.', 'armGroupLabels': ['Candesartan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60108', 'city': 'Bloomingdale', 'state': 'Illinois', 'country': 'United States', 'facility': 'ACCESS Martin T. Russo Family Health Center', 'geoPoint': {'lat': 41.95753, 'lon': -88.0809}}, {'zip': '60609', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Ashland Family Health Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Mark D Huffman, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University Feinberg School of Medicine'}, {'name': 'Jody D Ciolino, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Overall Study Officials:'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be available within 1 year of study conclusion.', 'ipdSharing': 'YES', 'description': 'Individual participant data will be shared through NHLBI BioLINCC.', 'accessCriteria': 'Access to study data will be managed through NHLBI BioLINCC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'ACCESS Community Health Network', 'class': 'OTHER'}, {'name': 'University of Sydney', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine and Global Health Center Co-Director', 'investigatorFullName': 'Mark Huffman', 'investigatorAffiliation': 'Washington University School of Medicine'}}}}