Viewing Study NCT04007406

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Ignite Creation Date: 2025-12-26 @ 10:59 AM
Ignite Modification Date: 2025-12-31 @ 1:17 PM
Study NCT ID: NCT04007406
Status: COMPLETED
Last Update Posted: 2024-11-22
First Post: 2019-07-01
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: DP13 - A Phase II Study in Patients With Primary Aldosteronism
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006929', 'term': 'Hyperaldosteronism'}], 'ancestors': [{'id': 'D000308', 'term': 'Adrenocortical Hyperfunction'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'teresa.gerlock@damianpharma.com', 'phone': '+41 79 230 8591', 'title': 'Teresa Gerlock/Chief Operations Officer', 'organization': 'DAMIAN Pharma AG'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected from baseline (before treatment with dexfadrostat phosphate) to the end of 8 weeks of treatment with dexfadrostat phosphate', 'description': 'All patients receiving at least one dose of dexfadrostat phosphate (safety population). The safety population included the full analysis set.', 'eventGroups': [{'id': 'EG000', 'title': '4 mg DP13', 'description': 'Patients receiving low dose dexfadrostat phosphate daily for 8 weeks', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 4, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '8 mg DP13', 'description': 'Patients receiving middle dose dexfadrostat phosphate daily for 8 weeks', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 6, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '12 mg DP13', 'description': 'Patients receiving high dose dexfadrostat phosphate daily for 8 weeks', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 7, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Amylase increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Blood lactate dehydrogenase increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood pressure diastolic increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Duodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastroesophageal reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Amenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Breast tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Polymenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dyspnea exertional', 'notes': 'Dyspnea during exercise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Lower limb edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastric leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '2.0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Aldosterone-to-renin Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '4 mg DP13', 'description': 'Values are after 8 weeks of treatment with dexfadrostat phosphate'}, {'id': 'OG001', 'title': '8 mg DP13', 'description': 'Values are after 8 weeks of treatment with dexfadrostat phosphate'}, {'id': 'OG002', 'title': '12 mg DP13', 'description': 'Values are after 8 weeks of treatment with dexfadrostat phosphate'}, {'id': 'OG003', 'title': 'All Dose Arms Combined', 'description': 'Values are after 8 weeks of treatment with dexfadrostat phosphate'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.0', 'groupId': 'OG000', 'lowerLimit': '-25.5', 'upperLimit': '-5.7'}, {'value': '-7.0', 'groupId': 'OG001', 'lowerLimit': '-16.0', 'upperLimit': '-2.7'}, {'value': '-14.0', 'groupId': 'OG002', 'lowerLimit': '-20.8', 'upperLimit': '-8.4'}, {'value': '-11.8', 'groupId': 'OG003', 'lowerLimit': '-23.8', 'upperLimit': '-4.9'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'pValueComment': 'The threshold value for statistical significance was p\\<0.05', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '8 weeks', 'description': 'Change from baseline in aldosterone-to-renin ratio (ARR) after 8 weeks of dexfadrostat phosphate treatment by dose group.', 'unitOfMeasure': 'ng*L/dL*mU', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Ambulatory Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '4 mg DP13', 'description': 'Values are after 8 weeks of treatment with dexfadrostat phosphate'}, {'id': 'OG001', 'title': '8 mg DP13', 'description': 'Values are after 8 weeks of treatment with dexfadrostat phosphate'}, {'id': 'OG002', 'title': '12 mg DP13', 'description': 'Values are after 8 weeks of treatment with dexfadrostat phosphate'}, {'id': 'OG003', 'title': 'All Dose Arms Combined', 'description': 'Values are after 8 weeks of treatment with dexfadrostat phosphate'}], 'classes': [{'categories': [{'measurements': [{'value': '-8', 'spread': '10', 'groupId': 'OG000'}, {'value': '-14', 'spread': '8', 'groupId': 'OG001'}, {'value': '-10', 'spread': '9', 'groupId': 'OG002'}, {'value': '-11', 'spread': '9', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'pValueComment': 'The threshold for significance was p \\<0.05', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'All patients receiving at least one dose of dexfadrostat phosphate; analysis of all dose arms combined.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '4 mg DP13', 'description': 'Values are after 8 weeks of treatment with dexfadrostat phosphate'}, {'id': 'OG001', 'title': '8 mg DP13', 'description': 'Values are after 8 weeks of treatment with dexfadrostat phosphate'}, {'id': 'OG002', 'title': '12 mg DP13', 'description': 'Values are after 8 weeks of treatment with dexfadrostat phosphate'}], 'classes': [{'categories': [{'measurements': [{'value': '0.74', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '0.55', 'spread': '0.29', 'groupId': 'OG001'}, {'value': '0.28', 'spread': '0.55', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'pValueComment': 'The threshold for significance was p \\<0.05', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Change from baseline after 8 weeks of treatment with dexfadrostat phosphate', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Ambulatory Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '4 mg DP13', 'description': 'Values are after 8 weeks of treatment with dexfadrostat phosphate'}, {'id': 'OG001', 'title': '8 mg DP13', 'description': 'Values are after 8 weeks of treatment with dexfadrostat phosphate'}, {'id': 'OG002', 'title': '12 mg DP13', 'description': 'Values are after 8 weeks of treatment with dexfadrostat phosphate'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.5', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '-7.9', 'spread': '6.4', 'groupId': 'OG001'}, {'value': '-4.5', 'spread': '7.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'pValueComment': 'The threshold for significance was p \\<0.05', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Change from baseline following 8-weeks of dexfadrostat phosphate treatment', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in 24-hour Urinary Tetrahydroaldosterone Content (uTHA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '4 mg DP13', 'description': 'Values are 8 weeks of treatment with dexfadrostat phosphate'}, {'id': 'OG001', 'title': '8 mg DP13', 'description': 'Values are 8 weeks of treatment with dexfadrostat phosphate'}, {'id': 'OG002', 'title': '12 mg DP13', 'description': 'Values are 8 weeks of treatment with dexfadrostat phosphate'}], 'classes': [{'categories': [{'measurements': [{'value': '-61.0', 'groupId': 'OG000', 'lowerLimit': '-86.0', 'upperLimit': '-45.0'}, {'value': '-50.0', 'groupId': 'OG001', 'lowerLimit': '-74.0', 'upperLimit': '-28.5'}, {'value': '-66.0', 'groupId': 'OG002', 'lowerLimit': '-71.0', 'upperLimit': '-41.0'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'pValueComment': 'The statistical threshold was p\\<0.05', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '8 weeks', 'description': 'Change from baseline in urinary tetrahydroaldosterone content (uTHA) following 8 weeks of treatment with dexfadrostat phosphate', 'unitOfMeasure': 'ug/24 hour urine', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '4 mg DP13', 'description': 'Patients receiving the low dose of dexfadrostat phosphate taken orally, once daily, in the morning before breakfast'}, {'id': 'FG001', 'title': '8 mg DP13', 'description': 'Patients receiving the middle dose of dexfadrostat phosphate taken orally, once daily, in the morning before breakfast'}, {'id': 'FG002', 'title': '12 mg DP13', 'description': 'Patients receiving the high dose of dexfadrostat phosphate taken orally, once daily, in the morning before breakfast'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Patients were recruited 'de novo' i.e., diagnosed with Primary Aldosteronism within 10 weeks of study entry or as 'recently diagnosed' i.e., diagnosed between 10 weeks and 1 year prior to study entry", 'preAssignmentDetails': 'Patient screening ARR and BP were reviewed and approved by the Eligibility Review Panel prior to study enrollment.\n\nA suppression test was required prior to study entry to confirm PA diagnosis. Patients had a 2-week placebo run-in prior to randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '4 mg DP13', 'description': 'Baseline values were determined following 2 weeks of single-blind placebo run-in'}, {'id': 'BG001', 'title': '8 mg DP13', 'description': 'Baseline values were determined following 2 weeks of single-blind placebo run-in'}, {'id': 'BG002', 'title': '12 mg DP13', 'description': 'Baseline values were determined following 2 weeks of single-blind placebo run-in'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Switzerland', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Office systolic blood pressure (oSBP)', 'classes': [{'categories': [{'measurements': [{'value': '147', 'spread': '14', 'groupId': 'BG000'}, {'value': '148', 'spread': '6', 'groupId': 'BG001'}, {'value': '148', 'spread': '14', 'groupId': 'BG002'}, {'value': '148', 'spread': '12', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Office diastolic blood pressure (oDBP)', 'classes': [{'categories': [{'measurements': [{'value': '90', 'spread': '11', 'groupId': 'BG000'}, {'value': '95', 'spread': '9', 'groupId': 'BG001'}, {'value': '92', 'spread': '9', 'groupId': 'BG002'}, {'value': '92', 'spread': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Aldosterone-to-renin ratio (ARR)', 'classes': [{'categories': [{'measurements': [{'value': '21.4', 'groupId': 'BG000', 'lowerLimit': '6.8', 'upperLimit': '28.9'}, {'value': '7.2', 'groupId': 'BG001', 'lowerLimit': '2.9', 'upperLimit': '17.5'}, {'value': '17.8', 'groupId': 'BG002', 'lowerLimit': '9.0', 'upperLimit': '25.2'}, {'value': '15.3', 'groupId': 'BG003', 'lowerLimit': '5.3', 'upperLimit': '25.9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ng*L/dL*mU', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': '24-hour ambulatory systolic blood pressure (aSBP)', 'classes': [{'categories': [{'measurements': [{'value': '137', 'spread': '16', 'groupId': 'BG000'}, {'value': '145', 'spread': '14', 'groupId': 'BG001'}, {'value': '145', 'spread': '13', 'groupId': 'BG002'}, {'value': '143', 'spread': '14', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '24-hour ambulatory diastolic blood pressure (aDBP)', 'classes': [{'categories': [{'measurements': [{'value': '84', 'spread': '9', 'groupId': 'BG000'}, {'value': '90', 'spread': '7', 'groupId': 'BG001'}, {'value': '89', 'spread': '7', 'groupId': 'BG002'}, {'value': '88', 'spread': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Potassium', 'classes': [{'categories': [{'measurements': [{'value': '3.36', 'spread': '0.45', 'groupId': 'BG000'}, {'value': '3.55', 'spread': '0.31', 'groupId': 'BG001'}, {'value': '3.54', 'spread': '0.41', 'groupId': 'BG002'}, {'value': '3.49', 'spread': '0.39', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '24-hour Urinary Tetrahydroaldosterone Content (uTHA)', 'classes': [{'categories': [{'measurements': [{'value': '80.0', 'groupId': 'BG000', 'lowerLimit': '54.0', 'upperLimit': '102.0'}, {'value': '59.5', 'groupId': 'BG001', 'lowerLimit': '41.0', 'upperLimit': '76.0'}, {'value': '69.0', 'groupId': 'BG002', 'lowerLimit': '56.0', 'upperLimit': '76.0'}, {'value': '67.0', 'groupId': 'BG003', 'lowerLimit': '45.0', 'upperLimit': '97.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ug/24h', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-12', 'size': 1305904, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-12-05T11:26', 'hasProtocol': True}]}}, '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': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-03', 'studyFirstSubmitDate': '2019-07-01', 'resultsFirstSubmitDate': '2023-12-06', 'studyFirstSubmitQcDate': '2019-07-02', 'lastUpdatePostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-03', 'studyFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Aldosterone-to-renin Ratio', 'timeFrame': '8 weeks', 'description': 'Change from baseline in aldosterone-to-renin ratio (ARR) after 8 weeks of dexfadrostat phosphate treatment by dose group.'}, {'measure': 'Change in Ambulatory Systolic Blood Pressure', 'timeFrame': '8 weeks', 'description': 'All patients receiving at least one dose of dexfadrostat phosphate; analysis of all dose arms combined.'}], 'secondaryOutcomes': [{'measure': 'Change in Potassium', 'timeFrame': '8 weeks', 'description': 'Change from baseline after 8 weeks of treatment with dexfadrostat phosphate'}, {'measure': 'Change in Ambulatory Diastolic Blood Pressure', 'timeFrame': '8 weeks', 'description': 'Change from baseline following 8-weeks of dexfadrostat phosphate treatment'}, {'measure': 'Change in 24-hour Urinary Tetrahydroaldosterone Content (uTHA)', 'timeFrame': '8 weeks', 'description': 'Change from baseline in urinary tetrahydroaldosterone content (uTHA) following 8 weeks of treatment with dexfadrostat phosphate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hyperaldosteronism'], 'conditions': ['Primary Aldosteronism']}, 'descriptionModule': {'briefSummary': 'The purpose of the present phase II study is to determine whether DP13 displays the clinical safety and efficacy profile to support further development in patients with primary aldosteronism.', 'detailedDescription': 'A phase II, multi-centre, randomized, parallel group, baseline-and withdrawal-controlled study in patients with primary aldosteronism to determine the dose-dependent efficacy, safety and tolerability of DP13 after a 2-week single-blind placebo run-in period followed by a randomized 8-week double-blind treatment period. After an additional single-blind, 2-week DP13 placebo withdrawal period, patients are switched to standard of care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with a guideline-recommended diagnosis of primary aldosteronism\n\nExclusion Criteria:\n\nPatients with primary aldosteronism and\n\n* hyperkalemia\n* prolonged QT intervals\n* refusal of special contraception measures'}, 'identificationModule': {'nctId': 'NCT04007406', 'briefTitle': 'DP13 - A Phase II Study in Patients With Primary Aldosteronism', 'organization': {'class': 'INDUSTRY', 'fullName': 'Damian Pharma AG'}, 'officialTitle': 'DP13 - A Phase II Study in Patients With Primary Aldosteronism to Evaluate the Efficacy, Safety and Tolerability of DP13, Over an 8-week Treatment Period', 'orgStudyIdInfo': {'id': 'DP13C201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '4 mg DP13 daily', 'description': 'DP13 for 8 weeks', 'interventionNames': ['Drug: dexfadrostat phosphate']}, {'type': 'EXPERIMENTAL', 'label': '8 mg DP13 daily', 'description': 'DP13 for 8 weeks', 'interventionNames': ['Drug: dexfadrostat phosphate']}, {'type': 'EXPERIMENTAL', 'label': '12 mg DP13 daily', 'description': 'DP13 for 8 weeks', 'interventionNames': ['Drug: dexfadrostat phosphate']}], 'interventions': [{'name': 'dexfadrostat phosphate', 'type': 'DRUG', 'otherNames': ['DP13'], 'description': 'DP13 systemic administration', 'armGroupLabels': ['12 mg DP13 daily', '4 mg DP13 daily', '8 mg DP13 daily']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10126', 'city': 'Torino', 'country': 'Italy', 'facility': 'Ospedale Molinette', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}], 'overallOfficials': [{'name': 'Paolo Mulatero, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Torino, Torino, Italy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Damian Pharma AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}