Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:52 PM
Study NCT ID:
NCT05432167
Status:
COMPLETED
Last Update Posted:
2025-05-20
First Post:
2022-06-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate CIN-107 for the Treatment of Patients With Uncontrolled Hypertension and Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479', 'title': 'Global Clinical Lead', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': 'No unpublished information may be disclosed without prior written approval from AstraZeneca.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From randomization (Day 1) until the end of Follow up period (approximately 8 months)', 'description': 'Safety population included all participants who received at least one dose of any study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'CIN-107 Low Dosing Strategy Group', 'description': 'Participants received oral tablets of low dose strengths of CIN-107 for 26 weeks.', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 47, 'seriousNumAtRisk': 65, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'CIN-107 High Dosing Strategy Group', 'description': 'Participants received oral tablets of high dose strengths of CIN-107 for 26 weeks.', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 52, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Participants received oral tablets of Placebo for 26 weeks.', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 35, 'seriousNumAtRisk': 64, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 30, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 52, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 20, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Glomerular filtration rate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Blood potassium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Activated partial thromboplastin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'SARS-CoV-2 test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Blood bicarbonate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Blood glucose decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Cardiac murmur', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Electrocardiogram QRS complex shortened', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Electrocardiogram QT interval abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Electrocardiogram abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Eosinophil count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Helicobacter test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Influenza A virus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'International normalised ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Tinea capitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Trichomoniasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 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0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Toxic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Nodal arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Generalised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Mean Seated Systolic Blood Pressure (SBP) of Pooled CIN-107 and Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CIN-107 Treatment Groups Pooled', 'description': 'Participants received oral tablets of high and low doses of CIN-107 for 26 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received oral tablets of Placebo for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.22', 'spread': '1.532', 'groupId': 'OG000'}, {'value': '-7.15', 'spread': '2.231', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.08', 'ciLowerLimit': '-13.36', 'ciUpperLimit': '-2.79', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.676', 'groupDescription': 'The analysis was performed using a mixed-effect model for repeated measures including fixed effects for treatment, visit, stratification variables (SGLT2 inhibitor use and CKD category), and the treatment-by-visit interaction, along with a covariate of the baseline seated SBP value and the baseline seated SBP by visit interaction.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At Week 26', 'description': 'Mean change in seated SBP from baseline to Week 26 of pooled CIN-107 and placebo was assessed.', 'unitOfMeasure': 'Millimeters of mercury (mmHg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "Modified Intent-to-treat (mITT) population included all participants in the ITT population who received at least 1 dose of any study drug.\n\nHere, 'overall number of participants analyzed' means the number of participants with non-missing data."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in SBP in CIN-107 Compared to Placebo in Participants Assigned to the High-dose Strategy Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CIN-107 High Dosing Strategy Group', 'description': 'Participants received oral tablets of high dose strengths of CIN-107 for 26 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received oral tablets of Placebo for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.37', 'spread': '2.117', 'groupId': 'OG000'}, {'value': '-7.16', 'spread': '2.233', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.019', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.22', 'ciLowerLimit': '-13.24', 'ciUpperLimit': '-1.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.051', 'groupDescription': 'The analysis was performed using a mixed-effect model for repeated measures including fixed effects for treatment, visit, stratification variables (SGLT2 inhibitor use and CKD category), and the treatment-by-visit interaction, along with a covariate of the baseline seated SBP value and the baseline seated SBP by visit interaction.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At Week 26', 'description': 'Mean change in seated SBP from baseline to Week 26 of high-dose CIN-107 dosing group and placebo was assessed.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all participants in the ITT population who received at least 1 dose of any study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of SBP in CIN-107 Compared to Placebo in Participants Assigned to the Low-dose Strategy Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CIN-107 Low Dosing Strategy Group', 'description': 'Participants received oral tablets of low dose strengths of CIN-107 for 26 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received oral tablets of Placebo for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.14', 'spread': '2.186', 'groupId': 'OG000'}, {'value': '-7.16', 'spread': '2.233', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.99', 'ciLowerLimit': '-15.10', 'ciUpperLimit': '-2.87', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.098', 'groupDescription': 'The analysis was performed using a mixed-effect model for repeated measures including fixed effects for treatment, visit, stratification variables (SGLT2 inhibitor use and CKD category), and the treatment-by-visit interaction, along with a covariate of the baseline seated SBP value and the baseline seated SBP by visit interaction.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At Week 26', 'description': 'The mean change in seated SBP from baseline to Week 26 of low-dose CIN-107 dosing group and placebo was assessed.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all participants in the ITT population who received at least 1 dose of any study drug.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CIN-107 Low Dosing Strategy Group', 'description': 'Participants received oral tablets of low dose strengths of CIN-107 for 26 weeks.'}, {'id': 'OG001', 'title': 'CIN-107 High Dosing Strategy Group', 'description': 'Participants received oral tablets of high dose strengths of CIN-107 for 26 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received oral tablets of Placebo for 26 weeks.'}], 'classes': [{'title': 'All TEAEs', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}]}, {'title': 'All TEAEs, related to treatment', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Any TEAE with outcome = Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any TEAE with outcome = Death, related to treatment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any TEAE leading to dose interruption', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Any TEAE leading to dose interruption, related to treatment', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Any TEAE leading to discontinuation of treatment', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Any TEAE leading to discontinuation of treatment, related to treatment', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Any TEAE leading to discontinuation of study', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Any TEAE leading to discontinuation of study, related to treatment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'All treatment emergent serious adverse events (TESAEs)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'All TESAEs, related to treatment', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Any TESAE with outcome = Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any TESAE with outcome = Death, related to treatment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any TESAE leading to dose interruption', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Any TESAE leading to dose interruption, related to treatment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Any TESAE leading to discontinuation of treatment', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Any TESAE leading to discontinuation of treatment, related to treatment', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any TESAE leading to discontinuation of study', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any TESAE leading to discontinuation of study, related to treatment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Treatment emergent AESIs', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization (Day 1) until the end of Follow up period (approximately 8 months)', 'description': 'The safety and tolerability of CIN-107 in participants with uncontrolled hypertension (uHTN) and chronic kidney disease (CKD) was assessed.\n\nAdverse events of special interest (AESI) include any hypotension events, abnormal potassium or sodium laboratory values that require clinical intervention.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least one dose of any study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CIN-107 Low Dosing Strategy Group', 'description': 'Participants received oral tablets of low dose strengths of CIN-107 for 26 weeks.'}, {'id': 'FG001', 'title': 'CIN-107 High Dosing Strategy Group', 'description': 'Participants received oral tablets of high dose strengths of CIN-107 for 26 weeks.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Participants received oral tablets of Placebo for 26 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '64'}, {'groupId': 'FG002', 'numSubjects': '66'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '54'}, {'groupId': 'FG002', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Inclusion/exclusion criteria not met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study was conducted from 29 April 2022 to 02 May 2024 at 78 sites in the United States.', 'preAssignmentDetails': 'Participants who met the inclusion criteria and none of the exclusion criteria were enrolled to the study. All study assessments were performed as per the schedule of assessment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '195', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'CIN-107 Low Dosing Strategy Group', 'description': 'Participants received oral tablets of low dose strengths of CIN-107 for 26 weeks.'}, {'id': 'BG001', 'title': 'CIN-107 High Dosing Strategy Group', 'description': 'Participants received oral tablets of high dose strengths of CIN-107 for 26 weeks.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Participants received oral tablets of Placebo for 26 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Age', 'categories': [{'measurements': [{'value': '67.2', 'spread': '12.63', 'groupId': 'BG000'}, {'value': '66.5', 'spread': '11.02', 'groupId': 'BG001'}, {'value': '65.6', 'spread': '10.79', 'groupId': 'BG002'}, {'value': '66.4', 'spread': '11.46', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '132', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '113', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat population (ITT) included all participants randomized into the study. Treatment classification was based on the randomized treatment assignment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-08-17', 'size': 24163333, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-05-02T08:26', 'hasProtocol': True}, {'date': '2024-06-18', 'size': 15880838, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-05-02T08:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 195}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-02', 'studyFirstSubmitDate': '2022-06-20', 'resultsFirstSubmitDate': '2025-03-25', 'studyFirstSubmitQcDate': '2022-06-20', 'lastUpdatePostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-02', 'studyFirstPostDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'From randomization (Day 1) until the end of Follow up period (approximately 8 months)', 'description': 'The safety and tolerability of CIN-107 in participants with uncontrolled hypertension (uHTN) and chronic kidney disease (CKD) was assessed.\n\nAdverse events of special interest (AESI) include any hypotension events, abnormal potassium or sodium laboratory values that require clinical intervention.'}], 'primaryOutcomes': [{'measure': 'Change From Baseline in Mean Seated Systolic Blood Pressure (SBP) of Pooled CIN-107 and Placebo', 'timeFrame': 'At Week 26', 'description': 'Mean change in seated SBP from baseline to Week 26 of pooled CIN-107 and placebo was assessed.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in SBP in CIN-107 Compared to Placebo in Participants Assigned to the High-dose Strategy Group', 'timeFrame': 'At Week 26', 'description': 'Mean change in seated SBP from baseline to Week 26 of high-dose CIN-107 dosing group and placebo was assessed.'}, {'measure': 'Change From Baseline of SBP in CIN-107 Compared to Placebo in Participants Assigned to the Low-dose Strategy Group', 'timeFrame': 'At Week 26', 'description': 'The mean change in seated SBP from baseline to Week 26 of low-dose CIN-107 dosing group and placebo was assessed.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Uncontrolled Hypertension', 'Chronic Kidney Diseases']}, 'referencesModule': {'references': [{'pmid': '40913594', 'type': 'DERIVED', 'citation': 'Dwyer JP, Maklad N, Vedin O, Monyak J, Myte R, Chertow GM, Heerspink HJL, Little DJ. Efficacy and Safety of Baxdrostat in Participants with CKD and Uncontrolled Hypertension: A Randomized, Double-Blind, Placebo-Controlled Trial. J Am Soc Nephrol. 2025 Sep 6. doi: 10.1681/ASN.0000000849. Online ahead of print. No abstract available.'}, {'pmid': '37490693', 'type': 'DERIVED', 'citation': 'Townsend RR. Blocking Aldosterone Synthesis: Whose BrigHTN Idea Was That? Clin J Am Soc Nephrol. 2023 Dec 1;18(12):1631-1633. doi: 10.2215/CJN.0000000000000265. Epub 2023 Jul 24. No abstract available.'}], 'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=CIN-107-123&attachmentIdentifier=b12e7f74-0d50-4db5-a61a-d7c873db4754&fileName=CSP_CIN-107-123_PDFA_Redacted.pdf&versionIdentifier=', 'label': 'Redacted CSP'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=CIN-107-123&attachmentIdentifier=eac2398c-f0a8-4811-8d5f-ba17e99f4de4&fileName=SAP_CIN-107-123_PDFA_Redacted.pdf&versionIdentifier=', 'label': 'Redacted SAP'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=CIN-107-123&attachmentIdentifier=1b1f4d13-ac35-470f-8f10-70eb60638d80&fileName=CSR_Synopsis_CIN-107-123_PDFA_Redacted.pdf&versionIdentifier=', 'label': 'Redacted CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and safety of CIN-107 for the treatment of hypertension in patients with uncontrolled hypertension (uHTN) and Chronic Kidney Disease (CKD).', 'detailedDescription': 'This randomized, double-blind, placebo-controlled will evaluate the efficacy and safety of CIN-107 in patients with uHTN and CKD. Approximately 200 patients will be randomized in a 1:1:1 ratio into 1 of the 3 treatment groups (placebo, low dose treatment strategy and high dose treatment strategy).\n\nThe study will consist of the following 3 periods:\n\n* A Screening Period of up to 5 weeks;\n* A Double-Blind Treatment Period of 26 weeks; and\n* A Follow-Up Period of 2 weeks.\n\nPatients will complete the study in approximately 8 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '130 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Has a mean seated SBP ≥ 140 mmHg.\n* Has a prior diagnosis of mild-to-severe CKD.\n* Has an elevated UACR.\n* Is currently taking an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) at the maximum tolerated daily dose.\n\nExclusion Criteria:\n\n* Have a documented diagnosis of type 1 diabetes.\n* Are not willing or not able to discontinue a mineralocorticoid receptor antagonist (MRA) or a potassium sparing diuretic as part of an existing antihypertensive regimen.\n* Have a single occurrence of mean seated SBP \\>180 mmHg or DBP \\>110 mmHg during the Screening Period.\n* Has a body mass index (BMI) \\>50 kg/m\\^2.\n* Has documented bilateral clinically relevant renal artery stenosis of ≥70%.\n* Has had dialysis for acute kidney injury/acute renal failure within 12 weeks prior to the Screening Period or has a planned dialysis or kidney transplantation during the course of the study.\n* Has known documented chronic heart failure New York Heart Association Class III or Class IV and/or hospitalization for heart failure within 6 months of Screening.\n* Has had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months of Screening.\n* Has known current severe left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy and/or severe aortic valvular disease.\n* Has planned any major cardiac surgery during the study or had major cardiac surgery within 6 months of Screening.\n* Has had a prior solid organ transplant or cell transplant.\n* Has a known hypersensitivity to CIN-107 or drugs of the same class\n* Has received immunotherapy for treatment of CKD within 6 months of Screening.\n* Has any clinically relevant medical or surgical conditions including unstable conditions and/or conditions requiring regular transfusion or treatment with systemic immunosuppressants, including corticosteroids.\n* Serum potassium \\<3.5 mEq/L or \\>5.0 mEq/L\n* Serum sodium \\<135 mEq/L\n* Serum aspartate aminotransferase or alanine aminotransferase \\>3 × upper limit of normal (ULN); or Total bilirubin \\>2 × ULN, unless due to Gilbert's syndrome.\n* GFR is \\< 25 or \\> 75 mL/min/1.73 m2\n* Has uncontrolled diabetes with glycosylated hemoglobin \\>10.5%.\n* Is positive for Human immunodeficiency disease (HIV) antibody, hepatitis B surface antigen, or hepatitis C virus Ribonucleic acid (RNA).\n* Has typical consumption of \\>14 alcoholic drinks weekly."}, 'identificationModule': {'nctId': 'NCT05432167', 'briefTitle': 'A Study to Evaluate CIN-107 for the Treatment of Patients With Uncontrolled Hypertension and Chronic Kidney Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group, Dose-Ranging Study to Evaluate CIN-107 for the Treatment of Patients With Uncontrolled Hypertension and Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'CIN-107-123'}, 'secondaryIdInfos': [{'id': 'D6972C00001', 'type': 'OTHER', 'domain': 'AstraZeneca'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low dose CIN-107', 'description': 'Patients will take oral tablets of CIN-107 for 26 weeks. The dose strength may be titrated within 6 weeks.', 'interventionNames': ['Drug: CIN-107']}, {'type': 'EXPERIMENTAL', 'label': 'High dose CIN-107', 'description': 'Patients will take oral tablets of CIN-107 for 26 weeks. The dose strength may be titrated within 6 weeks.', 'interventionNames': ['Drug: CIN-107']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients will take oral tablets of Placebo for 26 weeks. The dose strength may be titrated within 6 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'CIN-107', 'type': 'DRUG', 'description': 'Patients will take CIN-107 tablets by mouth once daily.', 'armGroupLabels': ['High dose CIN-107', 'Low dose CIN-107']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Patients will take placebo tablets by mouth once daily.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35805', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '91910', 'city': 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