Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-01-02 @ 6:46 AM
Study NCT ID:
NCT04712669
Status:
COMPLETED
Last Update Posted:
2025-06-04
First Post:
2021-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (Core OLE)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}], 'ancestors': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000621040', 'term': 'rodatristat'}, {'id': 'C494814', 'term': 'BID protein, human'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ravi.grewal@us.sumitomo-pharma.com', 'phone': '+1 (508) 481-6700', 'title': 'Ravi Grewal', 'organization': 'Sumitomo Pharma America'}, 'certainAgreement': {'otherDetails': 'In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 48 weeks', 'description': 'An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.', 'eventGroups': [{'id': 'EG000', 'title': 'Rodatristat Ethyl 300 mg BID', 'description': 'MAIN study: Rodatristat ethyl 300 mg and placebo tablet BID + standard of care medication(s) taken for 24 weeks', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 32, 'seriousNumAtRisk': 36, 'deathsNumAffected': 1, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Rodatristat Ethyl 600 mg BID', 'description': 'MAIN study:Rodatristat ethyl two 300 mg tablets BID + standard of care medication(s) taken for 24 weeks', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 34, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Placebo', 'description': 'MAIN study: Matching two placebo tablets BID+ standard of care medication(s) taken for 24 weeks', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 27, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Placebo-Rodatristat Ethyl 300 mg', 'description': 'Subjects whose actual treatment group is Placebo in the double-blind phase (Main Study) and received Rodatristat ethyl two 300 mg tablets BID in the open-label phase', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 12, 'seriousNumAtRisk': 15, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Placebo-Rodatristat Ethyl 600 mg', 'description': 'Subjects whose actual treatment group is Placebo in the double-blind phase (Main Study) and received Rodatristat ethyl two 600 mg tablets BID in the open-label phase', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 15, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG005', 'title': 'Rodatristat Ethyl 300 Mg-Rodatristat Ethyl 300 mg', 'description': 'Subjects whose actual treatment group is Rodatristat ethyl two 300 mg in the double-blind phase (Main Study) and received Rodatristat ethyl two 300 mg tablets BID in the open-label phase', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 12, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG006', 'title': 'Rodatristat Ethyl 300 Mg-Rodatristat Ethyl 600 mg', 'description': 'Subjects whose actual treatment group is Rodatristat ethyl two 300 mg in the double-blind phase (Main Study) and 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'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Device related thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Anticoagulation drug level below therapeutic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Transplant evaluation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Device extrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Device breakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Device malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '0.05'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline of Pulmonary Vascular Resistance (PVR) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rodatristat Ethyl 300 mg BID', 'description': 'MAIN study: Rodatristat ethyl 300 mg and placebo tablet BID + standard of care medication(s) taken for 24 weeks'}, {'id': 'OG001', 'title': 'Rodatristat Ethyl 600 mg BID', 'description': 'MAIN study:Rodatristat ethyl two 300 mg tablets BID + standard of care medication(s) taken for 24 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'MAIN study: Matching two placebo tablets BID+ standard of care medication(s) taken for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '63.083', 'spread': '18.529', 'groupId': 'OG000'}, {'value': '64.219', 'spread': '18.013', 'groupId': 'OG001'}, {'value': '5.813', 'spread': '18.052', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0208', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '57.27', 'ciLowerLimit': '8.716', 'ciUpperLimit': '105.824', 'pValueComment': 'LSM, SE, CIs for each treatment group; LSM Diff, SE, CIs, and p-value are estimated using an ANCOVA model incl. factors for treatment group and randomization strata with associated baseline value as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '24.773', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'H0: The mean change from baseline in PVR at Week 24 is equal between placebo and rodatristat ethyl.'}, {'pValue': '0.0174', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '58.406', 'ciLowerLimit': '10.272', 'ciUpperLimit': '106.54', 'pValueComment': 'LSM, SE, CIs for each treatment group; LSM Diff, SE, CIs, and p-value are estimated using an ANCOVA model incl. factors for treatment group and randomization strata with associated baseline value as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '24.558', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'H0: The mean change from baseline in PVR at Week 24 is equal between placebo and rodatristat ethyl.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 Weeks', 'description': 'Pulmonary vascular resistance (PVR) was measured by right heart catheterization (RHC)', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in World Health Organization (WHO) Functional Class (FC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rodatristat Ethyl 300 mg BID', 'description': 'MAIN study: Rodatristat ethyl 300 mg and placebo tablet BID + standard of care medication(s) taken for 24 weeks'}, {'id': 'OG001', 'title': 'Rodatristat Ethyl 600 mg BID', 'description': 'MAIN study:Rodatristat ethyl two 300 mg tablets BID + standard of care medication(s) taken for 24 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'MAIN study: Matching two placebo tablets BID+ standard of care medication(s) taken for 24 weeks'}], 'classes': [{'categories': [{'title': '-II', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': '-I', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': 'No Change', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}, {'title': 'I', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': 'II', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.573', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'P-value based on ordinal logistic regression with treatment group and randomization stratification strata as factors at alpha=0.05.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'H0: The distribution of change from baseline in WHO FC at Week 24 is equal between placebo and rodatristat ethyl.'}, {'pValue': '0.9911', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'P-value based on ordinal logistic regression with treatment group and randomization stratification strata as factors at alpha=0.05.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'H0: The distribution of change from baseline in WHO FC at Week 24 is equal between placebo and rodatristat ethyl.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 Weeks', 'description': 'PAH functional disease severity is classified in 4 classes (I to IV) according to World Health Organization (WHO).\n\nI:Patients with pulmonary hypertension (PH) but without resulting limitation of physical act.Ordinary physical act does not cause undue dyspnea,fatigue,chest pain,near syncope.\n\nII:Patients with PH with slight limitation of physical act.Ordinary physical act causes undue dyspnea or fatigue, chest pain,or near syncope.\n\nIII:Patients with PH with marked limitation of physical act.Less than ordinary act causes undue dyspnea or fatigue,chest pain,or near syncope.\n\nIV:Patients with PH with inability to carry out any physical act without symptoms,manifest signs of right-heart failure.Dyspnea and/or fatigue may even be present at rest.Discomfort is increased by physical act\n\n-II, -I:Patients condition improved at WK24 compared with baseline II, I:Patients condition worsened at WK24 compared with baseline No change:Patients condition not changes at WK24 compare with baseline', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Six-minute Walk Distance (6MWD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rodatristat Ethyl 300 mg BID', 'description': 'MAIN study: Rodatristat ethyl 300 mg and placebo tablet BID + standard of care medication(s) taken for 24 weeks'}, {'id': 'OG001', 'title': 'Rodatristat Ethyl 600 mg BID', 'description': 'MAIN study:Rodatristat ethyl two 300 mg tablets BID + standard of care medication(s) taken for 24 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'MAIN study: Matching two placebo tablets BID+ standard of care medication(s) taken for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.5', 'groupId': 'OG000', 'lowerLimit': '-31.50', 'upperLimit': '28.00'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-27.50', 'upperLimit': '20.00'}, {'value': '2.5', 'groupId': 'OG002', 'lowerLimit': '-13.50', 'upperLimit': '23.00'}]}]}], 'analyses': [{'pValue': '0.0636', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-33.61', 'ciLowerLimit': '-69.13', 'ciUpperLimit': '1.91', 'pValueComment': 'p-value (alpha=0.05) is estimated using the aligned rank stratified Wilcoxon test with the randomization stratification factors as strata.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '18.121', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'H0: The distribution of change from baseline at Week 24 in 6MWT distance (meters) is equal between placebo and rodatristat ethyl.'}, {'pValue': '0.1573', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.05', 'ciLowerLimit': '-45.45', 'ciUpperLimit': '7.35', 'pValueComment': 'p-value (alpha=0.05) is estimated using the aligned rank stratified Wilcoxon test with the randomization stratification factors as strata.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.469', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'H0: The distribution of change from baseline at Week 24 in 6MWT distance (meters) is equal between placebo and rodatristat ethyl.'}], 'paramType': 'MEDIAN', 'timeFrame': '24 Weeks', 'description': 'The six-minute walk distance (6MWD) is a simple, commonly used, standardized measure of functional exercise capacity and endurance. It is a commonly used measure of efficacy in PAH clinical studies.', 'unitOfMeasure': 'six-minute walk distance (6MWD) (meters)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rodatristat Ethyl 300 mg BID', 'description': 'MAIN study: Rodatristat ethyl 300 mg and placebo tablet BID + standard of care medication(s) taken for 24 weeks'}, {'id': 'OG001', 'title': 'Rodatristat Ethyl 600 mg BID', 'description': 'MAIN study:Rodatristat ethyl two 300 mg tablets BID + standard of care medication(s) taken for 24 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'MAIN study: Matching two placebo tablets BID+ standard of care medication(s) taken for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1145.7', 'spread': '325.93', 'groupId': 'OG000'}, {'value': '886.1', 'spread': '275.70', 'groupId': 'OG001'}, {'value': '19.8', 'spread': '143.86', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0014', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1125.9', 'ciLowerLimit': '437.39', 'ciUpperLimit': '1814.39', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '351.28', 'estimateComment': 'Estimates from a REML MMRM with baseline covariate, fixed effects, and unstructured covariance.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'H0: The mean change from baseline at Week 24 in NT-proBNP is equal between placebo and rodatristat ethyl.'}, {'pValue': '0.0047', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '866.3', 'ciLowerLimit': '265.41', 'ciUpperLimit': '1467.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '306.56', 'estimateComment': 'Estimates from a REML MMRM with baseline covariate, fixed effects, and unstructured covariance.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'H0: The mean change from baseline at Week 24 in NT-proBNP is equal between placebo and rodatristat ethyl.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 Weeks', 'description': 'N-terminal prohormone of brain natriuretic peptide (NT-proBNP) is a strong predictor of disease progression and mortality in PAH patients. Current PAH treatment guidelines recommend measurement of NT-proBNP levels for both risk assessment and longitudinal follow up. NT-proBNP levels are also a good marker of response to treatment.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rodatristat Ethyl 300 mg BID', 'description': 'MAIN study: Rodatristat ethyl 300 mg and placebo tablet BID + standard of care medication(s) taken for 24 weeks'}, {'id': 'FG001', 'title': 'Rodatristat Ethyl 600 mg BID', 'description': 'MAIN study:Rodatristat ethyl two 300 mg tablets BID + standard of care medication(s) taken for 24 weeks'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'MAIN study: Matching two placebo tablets BID+ standard of care medication(s) taken for 24 weeks'}, {'id': 'FG003', 'title': 'Placebo-Rodatristat Ethyl 300 mg', 'description': 'Subjects whose actual treatment group is Placebo in the double-blind phase (Main Study) and received Rodatristat ethyl two 300 mg tablets BID in the open-label phase'}, {'id': 'FG004', 'title': 'Placebo-Rodatristat Ethyl 600 mg', 'description': 'Subjects whose actual treatment group is Placebo in the double-blind phase (Main Study) and received Rodatristat ethyl two 600 mg tablets BID in the open-label phase'}, {'id': 'FG005', 'title': 'Rodatristat Ethyl 300 Mg-Rodatristat Ethyl 300 mg', 'description': 'Subjects whose actual treatment group is Rodatristat ethyl two 300 mg in the double-blind phase (Main Study) and received Rodatristat ethyl two 300 mg tablets BID in the open-label phase'}, {'id': 'FG006', 'title': 'Rodatristat Ethyl 300 Mg-Rodatristat Ethyl 600 mg', 'description': 'Subjects whose actual treatment group is Rodatristat ethyl two 300 mg in the double-blind phase (Main Study) and received Rodatristat ethyl two 600 mg tablets BID in the open-label phase'}, {'id': 'FG007', 'title': 'Rodatristat Ethyl 600 Mg-Rodatristat Ethyl 600 mg', 'description': 'Subjects whose actual treatment group is Rodatristat ethyl two 600 mg in the double-blind phase (Main Study) and received Rodatristat ethyl two 600 mg tablets BID in the open-label phase'}], 'periods': [{'title': 'Double Blind Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '36'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '32'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Termination by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}, {'title': 'Open Label Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '22'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '22'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '4'}]}, {'type': 'Termination by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '14'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '14'}]}]}], 'preAssignmentDetails': 'Out of 108 subjects who are dosed in Double Blind phase 76 Subjects have enrolled in Open Label extension phase.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '21', 'groupId': 'BG007'}, {'value': '184', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'Rodatristat Ethyl 300 mg BID', 'description': 'MAIN study: Rodatristat ethyl 300 mg and placebo tablet BID + standard of care medication(s) taken for 24 weeks'}, {'id': 'BG001', 'title': 'Rodatristat Ethyl 600 mg BID', 'description': 'MAIN study:Rodatristat ethyl two 300 mg tablets BID + standard of care medication(s) taken for 24 weeks'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'MAIN study: Matching two placebo tablets BID+ standard of care medication(s) taken for 24 weeks'}, {'id': 'BG003', 'title': 'Placebo-Rodatristat Ethyl 300 mg', 'description': 'Subjects whose actual treatment group is Placebo in the double-blind phase (Main Study) and received Rodatristat ethyl two 300 mg tablets BID in the open-label phase'}, {'id': 'BG004', 'title': 'Placebo-Rodatristat Ethyl 600 mg', 'description': 'Subjects whose actual treatment group is Placebo in the double-blind phase (Main Study) and received Rodatristat ethyl two 600 mg tablets BID in the open-label phase'}, {'id': 'BG005', 'title': 'Rodatristat Ethyl 300 Mg-Rodatristat Ethyl 300 mg', 'description': 'Subjects whose actual treatment group is Rodatristat ethyl two 300 mg in the double-blind phase (Main Study) and received Rodatristat ethyl two 300 mg tablets BID in the open-label phase'}, {'id': 'BG006', 'title': 'Rodatristat Ethyl 300 Mg-Rodatristat Ethyl 600 mg', 'description': 'Subjects whose actual treatment group is Rodatristat ethyl two 300 mg in the double-blind phase (Main Study) and received Rodatristat ethyl two 600 mg tablets BID in the open-label phase'}, {'id': 'BG007', 'title': 'Rodatristat Ethyl 600 Mg-Rodatristat Ethyl 600 mg', 'description': 'Subjects whose actual treatment group is Rodatristat ethyl two 600 mg in the double-blind phase (Main Study) and received Rodatristat ethyl two 600 mg tablets BID in the open-label phase'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'title': 'Double Blind Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '108', 'groupId': 'BG008'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '78', 'groupId': 'BG008'}]}, {'title': '>=65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '30', 'groupId': 'BG008'}]}]}, {'title': 'Open Label Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '21', 'groupId': 'BG007'}, {'value': '76', 'groupId': 'BG008'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '16', 'groupId': 'BG007'}, {'value': '51', 'groupId': 'BG008'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '25', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Safety Population'}, {'title': 'Age, Continuous', 'classes': [{'title': 'Double Blind Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '108', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '56.4', 'spread': '14.3', 'groupId': 'BG000'}, {'value': '48.4', 'spread': '15.31', 'groupId': 'BG001'}, {'value': '53.7', 'spread': '13.76', 'groupId': 'BG002'}, {'value': '52.83', 'spread': '14.84', 'groupId': 'BG008'}]}]}, {'title': 'Open Label Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '21', 'groupId': 'BG007'}, {'value': '76', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '53.8', 'spread': '13.96', 'groupId': 'BG003'}, {'value': '53.4', 'spread': '14.19', 'groupId': 'BG004'}, {'value': '59.8', 'spread': '15.84', 'groupId': 'BG005'}, {'value': '53.0', 'spread': '5.65', 'groupId': 'BG006'}, {'value': '51.1', 'spread': '13.3', 'groupId': 'BG007'}, {'value': '54.68', 'spread': '14.65', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Safety Population'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Double Blind Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '108', 'groupId': 'BG008'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '85', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '23', 'groupId': 'BG008'}]}]}, {'title': 'Open Label Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '21', 'groupId': 'BG007'}, {'value': '76', 'groupId': 'BG008'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '19', 'groupId': 'BG007'}, {'value': '62', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '14', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Safety Population'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Double Blind Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': 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'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 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{'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '12', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Safety Population'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '108', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '0', 'groupId': 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'BG008'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}]}]}, {'title': 'Bosnia and Herzegovina', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '108', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 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'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '21', 'groupId': 'BG007'}, {'value': '76', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}]}, {'title': 'Austria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '21', 'groupId': 'BG007'}, {'value': '76', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}]}, {'title': 'Belgium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '21', 'groupId': 'BG007'}, {'value': '76', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}]}, {'title': 'Czechia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '21', 'groupId': 'BG007'}, {'value': '76', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}]}]}, {'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '21', 'groupId': 'BG007'}, {'value': '76', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '10', 'groupId': 'BG008'}]}]}, {'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '21', 'groupId': 'BG007'}, {'value': '76', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}]}]}, {'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '21', 'groupId': 'BG007'}, {'value': '76', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}]}]}, {'title': 'Latvia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '21', 'groupId': 'BG007'}, {'value': '76', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}]}]}, {'title': 'Spain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '21', 'groupId': 'BG007'}, {'value': '76', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}]}]}, {'title': 'Bosnia and Herzegovina', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '21', 'groupId': 'BG007'}, {'value': '76', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}]}, {'title': 'Moldova', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '21', 'groupId': 'BG007'}, {'value': '76', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '10', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Study participants count by region of enrollment in Open Label Phase', 'unitOfMeasure': 'Participants', 'populationDescription': 'Safety Population'}, {'title': 'Duration since PAH diagnosis', 'classes': [{'title': 'Double Blind Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '108', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '6.18', 'spread': '4.268', 'groupId': 'BG000'}, {'value': '6.69', 'spread': '4.913', 'groupId': 'BG001'}, {'value': '8.65', 'spread': '6.486', 'groupId': 'BG002'}, {'value': '7.17', 'spread': '5.4', 'groupId': 'BG008'}]}]}, {'title': 'Open Label Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '21', 'groupId': 'BG007'}, {'value': '76', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '10.54', 'spread': '5.97', 'groupId': 'BG003'}, {'value': '7.39', 'spread': '6.98', 'groupId': 'BG004'}, {'value': '5.82', 'spread': '4.86', 'groupId': 'BG005'}, {'value': '8.05', 'spread': '3.18', 'groupId': 'BG006'}, {'value': '6.14', 'spread': '4.85', 'groupId': 'BG007'}, {'value': '7.22', 'spread': '5.8', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Year', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Safety Population'}, {'title': 'Duration since PAH diagnosis category', 'classes': [{'title': 'Double Blind Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '108', 'groupId': 'BG008'}]}], 'categories': [{'title': '<=5 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '48', 'groupId': 'BG008'}]}, {'title': '>5 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '60', 'groupId': 'BG008'}]}]}, {'title': 'Open Label Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '21', 'groupId': 'BG007'}, {'value': '76', 'groupId': 'BG008'}]}], 'categories': [{'title': '<=5 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '34', 'groupId': 'BG008'}]}, {'title': '>5 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '11', 'groupId': 'BG007'}, {'value': '42', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Safety Population'}, {'title': 'PAH classification', 'classes': [{'title': 'Double Blind Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '108', 'groupId': 'BG008'}]}], 'categories': [{'title': 'IPAH', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '58', 'groupId': 'BG008'}]}, {'title': 'HPAH', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '14', 'groupId': 'BG008'}]}, {'title': 'Drug or toxin', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}]}, {'title': 'PAH associated with connective tissue disease', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '15', 'groupId': 'BG008'}]}, {'title': 'PAH associated with congenital systemic pulmonary shunt', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '13', 'groupId': 'BG008'}]}]}, {'title': 'Open Label Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '21', 'groupId': 'BG007'}, {'value': '76', 'groupId': 'BG008'}]}], 'categories': [{'title': 'IPAH', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '41', 'groupId': 'BG008'}]}, {'title': 'HPAH', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '9', 'groupId': 'BG008'}]}, {'title': 'Drug or toxin', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}]}, {'title': 'PAH associated with connective tissue disease', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '11', 'groupId': 'BG008'}]}, {'title': 'PAH associated with congenital systemic pulmonary shunt', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '10', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Safety Population'}, {'title': 'Number of PAH therapies category', 'classes': [{'title': 'Double Blind Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 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[{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '108', 'groupId': 'BG008'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '89', 'groupId': 'BG008'}]}, {'title': 'No', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '19', 'groupId': 'BG008'}]}]}, {'title': 'Open Label Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '21', 'groupId': 'BG007'}, {'value': '76', 'groupId': 'BG008'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '16', 'groupId': 'BG007'}, {'value': '59', 'groupId': 'BG008'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '17', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Safety Population'}], 'populationDescription': 'Safety Population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-19', 'size': 2849032, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-09-30T12:55', 'hasProtocol': True}, {'date': '2023-06-28', 'size': 1352992, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-09-30T12:55', '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', 'interventionModelDescription': 'Following screening assessments, Patients will be enrolled into 1 of 3 treatment arms in a core double blind phase in 1:1:1 randomization. Subjects are allowed to participant into open label extension phase upon completion of double blind phase.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-02', 'studyFirstSubmitDate': '2021-01-12', 'resultsFirstSubmitDate': '2024-09-30', 'studyFirstSubmitQcDate': '2021-01-13', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-02', 'studyFirstPostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline of Pulmonary Vascular Resistance (PVR) at Week 24', 'timeFrame': '24 Weeks', 'description': 'Pulmonary vascular resistance (PVR) was measured by right heart catheterization (RHC)'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in World Health Organization (WHO) Functional Class (FC)', 'timeFrame': '24 Weeks', 'description': 'PAH functional disease severity is classified in 4 classes (I to IV) according to World Health Organization (WHO).\n\nI:Patients with pulmonary hypertension (PH) but without resulting limitation of physical act.Ordinary physical act does not cause undue dyspnea,fatigue,chest pain,near syncope.\n\nII:Patients with PH with slight limitation of physical act.Ordinary physical act causes undue dyspnea or fatigue, chest pain,or near syncope.\n\nIII:Patients with PH with marked limitation of physical act.Less than ordinary act causes undue dyspnea or fatigue,chest pain,or near syncope.\n\nIV:Patients with PH with inability to carry out any physical act without symptoms,manifest signs of right-heart failure.Dyspnea and/or fatigue may even be present at rest.Discomfort is increased by physical act\n\n-II, -I:Patients condition improved at WK24 compared with baseline II, I:Patients condition worsened at WK24 compared with baseline No change:Patients condition not changes at WK24 compare with baseline'}, {'measure': 'Change From Baseline in Six-minute Walk Distance (6MWD)', 'timeFrame': '24 Weeks', 'description': 'The six-minute walk distance (6MWD) is a simple, commonly used, standardized measure of functional exercise capacity and endurance. It is a commonly used measure of efficacy in PAH clinical studies.'}, {'measure': 'Change From Baseline in N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) Levels', 'timeFrame': '24 Weeks', 'description': 'N-terminal prohormone of brain natriuretic peptide (NT-proBNP) is a strong predictor of disease progression and mortality in PAH patients. Current PAH treatment guidelines recommend measurement of NT-proBNP levels for both risk assessment and longitudinal follow up. NT-proBNP levels are also a good marker of response to treatment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PAH'], 'conditions': ['Pulmonary Arterial Hypertension']}, 'referencesModule': {'references': [{'pmid': '39307144', 'type': 'DERIVED', 'citation': "Sitbon O, Skride A, Feldman J, Sahay S, Shlobin OA, McLaughlin V, Ghofrani HA, Langleben D, Parsley E, D'Souza G, Marmon T, Kamau-Kelley W, Jones R, Grewal R, Wring S, Palacios M, Naik H, Denning J, Lazarus HM, Humbert M. Safety and efficacy of rodatristat ethyl for the treatment of pulmonary arterial hypertension (ELEVATE-2): a dose-ranging, randomised, multicentre, phase 2b trial. Lancet Respir Med. 2024 Nov;12(11):865-876. doi: 10.1016/S2213-2600(24)00226-1. Epub 2024 Sep 19."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and efficacy of Rodatristat Ethyl in pulmonary arterial hypertension (PAH) patients.', 'detailedDescription': 'Rodatristat Ethyl is a peripherally restricted TPH inhibitor being studied as a potential treatment for PAH. This dose-ranging, randomized, double-blind, placebo-controlled, multicenter study will evaluate the effect of Rodatristat Ethyl from baseline on pulmonary vascular resistance as measured at right heart catheterization.\n\nPatients will be enrolled into a main study with an option to enroll into an open label extension.\n\nThe study is expected to enroll patients in the USA, Canada and Europe.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1\\. Male and female 18 years or older 2. Body Mass Index (BMI) \\>18kg/m2 to \\<=40kg/m2 3. Symptomatic PAH belonging to one of the following 2018 WHO Clinical Group 1 subtypes:\n\na. Idiopathic PAH b. Heritable PAH c. Drug- or toxin-induced d. PAH associated with:\n\n1. Connective tissue disease\n2. Congenital systemic to pulmonary shunt (atrial septal defect, ventricular septal defect, patent ductus arteriosus) repaired at least one year prior to Screening\n3. Human immunodeficiency virus (HIV) infection - if diagnosed with HIV, must have stable disease status defined as follows:\n\n 1. stable treatment with HIV medications for at least 8 weeks prior to Screening\n 2. no active opportunistic infection during the Screening Period\n 3. no hospitalizations due to HIV for at least 4 weeks prior to Screening\n4. WHO FC II or III\n5. Confirmed diagnosis of PAH and meet all the following hemodynamic criteria by means of a screening RHC completed prior to randomization:\n\n 1. mPAP of \\>20 mmHg\n 2. PVR ≥ 350 dyne•sec/cm5\n 3. Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) of ≤ 12 mmHg if PVR ≥ 350 and \\< 500 dyne•sec/cm5, or PCWP/LVEDP ≤ 15 mmHg if PVR ≥ 500 dyne•sec/cm5\n6. 6MWD of 100 to 550 meters at Screening\n7. Currently on a stable treatment regimen with one or more treatments approved for PAH. Stable therapy is defined as receiving the same medication(s) for ≥ 12 weeks prior to the screening RHC and at a stable dose level for each for ≥ 8 weeks prior to the screening RHC (see Protocol Section 6.6.2 for approved PAH medications). Any instances where doses of a medication have been missed prior to RHC must be discussed with the Medical Monitor prior to performing the RHC.\n8. Meet all of the following criteria determined by pulmonary function tests completed no more than 24 weeks prior to Screening (performed with or without bronchodilation):\n\n 1. Forced expiratory volume in one second (FEV1) ≥ 60% of predicted normal, and\n 2. Total lung capacity (TLC) ≥ 70% of predicted normal or FVC ≥ 70% predicted if TLC is not available; For subjects with CTD associated PAH, if TLC is ≥ 60% of predicted but \\< 70% of predicted of if FVC ≥ 60% or predicted but \\< 70% of predicted, high resolution computed tomography \\[HRCT\\] obtained within 6 months of screening may be utilized to demonstrate limited interstitial lung disease\n9. If participating in an exercise program for pulmonary rehabilitation, the program must have been initiated ≥ 12 weeks prior to Screening, and patient must agree to maintain the current level of rehabilitation for the first 24 weeks of receiving IP. If not participating in an exercise training program for pulmonary rehabilitation, patient must agree not to enroll in an exercise training program for pulmonary rehabilitation during the Screening Period and the first 24 weeks of receiving IP.\n\nExclusion Criteria:\n\n1. Women of childbearing potential who are pregnant, planning to become pregnant, or lactating or female/male patients unwilling to use effective contraception\n2. WHO pulmonary hypertension (PH) Group 1 PAH associated with portal hypertension or schistosomiasis; PH due to left heart disease (WHO PH Group 2), lung diseases and/or hypoxia (WHO PH Group 3), chronic thromboembolic PH (WHO PH Group 4), or PH with unclear multifactorial mechanisms (WHO PH Group 5)\n3. PH associated with significant venous or capillary involvement (PCWP \\> 15 mmHg), pulmonary capillary hemangiomatosis, portal hypertension, or unrepaired congenital heart defects (CHD)\n4. Three or more of the following risk factors for left ventricular disease:\n\n 1. BMI \\> 30 kg/m2\n 2. Diagnosis of essential hypertension that is actively treated\n 3. Diabetes mellitus\n 4. History of significant coronary artery disease (e.g., chronic stable angina, history of coronary intervention within the last 3 months, or a stenosis \\> 70% at coronary angiography)\n 5. Atrial fibrillation\n 6. Left atrial volume index \\> 41 mL/m2 \\[or left atrial diameter (LA) \\> 4 cm if LAVi unavailable\\]\n5. Known genetic hypertrophic cardiomyopathy\n6. Known cardiac sarcoidosis or amyloidosis\n7. The patient has a history of, or currently has, a constrictive cardiomyopathy.\n8. Known history of any left ventricular ejection fraction (LVEF) \\< 40% by echocardiogram within 3 years of randomization (Note: a transient decline in LVEF below 40% that occurred and recovered more than 6 months before the start of Screening and was associated with an acute intercurrent condition \\[e.g., atrial fibrillation\\] is allowed).\n9. Hemodynamically significant valvular heart disease as determined by the Investigator, including:\n\n 1. greater than mild aortic and/or mitral stenosis and/or\n 2. severe mitral and/or aortic regurgitation (\\> Grade 3)\n10. Severe arthritis, musculoskeletal problems, or morbid obesity that, in the opinion of the Investigator, is the cause of the patient's functional limitation and would affect the patient's ability to perform or complete the 6MWT."}, 'identificationModule': {'nctId': 'NCT04712669', 'briefTitle': 'A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (Core OLE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Altavant Sciences GmbH'}, 'officialTitle': 'A Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension', 'orgStudyIdInfo': {'id': 'RVT-1201-2002 / ELEVATE 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rodatristat Ethyl 300 mg BID', 'description': 'MAIN study: Rodatristat ethyl 300 mg and placebo tablet BID + standard of care medication(s) taken for 24 weeks', 'interventionNames': ['Drug: rodatristat ethyl 300 mg tablet BID']}, {'type': 'EXPERIMENTAL', 'label': 'Rodatristat Ethyl 600 mg BID', 'description': 'MAIN study:Rodatristat ethyl two 300 mg tablets BID + standard of care medication(s) taken for 24 weeks', 'interventionNames': ['Drug: rodatristat ethyl 600 mg BID']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'MAIN study: Matching two placebo tablets BID+ standard of care medication(s) taken for 24 weeks', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo-Rodatristat Ethyl 300 mg', 'description': 'Subjects whose actual treatment group is Placebo in the double-blind phase (Main Study) and received Rodatristat ethyl two 300 mg tablets BID in the open-label phase', 'interventionNames': ['Drug: rodatristat ethyl 300 mg tablet BID']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo-Rodatristat Ethyl 600 mg', 'description': 'Subjects whose actual treatment group is Placebo in the double-blind phase (Main Study) and received Rodatristat ethyl two 600 mg tablets BID in the open-label phase', 'interventionNames': ['Drug: rodatristat ethyl 600 mg BID']}, {'type': 'EXPERIMENTAL', 'label': 'Rodatristat Ethyl 300 mg-Rodatristat Ethyl 300 mg', 'description': 'Subjects whose actual treatment group is Rodatristat ethyl two 300 mg in the double-blind phase (Main Study) and received Rodatristat ethyl two 300 mg tablets BID in the open-label phase', 'interventionNames': ['Drug: rodatristat ethyl 300 mg tablet BID']}, {'type': 'EXPERIMENTAL', 'label': 'Rodatristat Ethyl 300 mg-Rodatristat Ethyl 600 mg', 'description': 'Subjects whose actual treatment group is Rodatristat ethyl two 300 mg in the double-blind phase (Main Study) and received Rodatristat ethyl two 600 mg tablets BID in the open-label phase', 'interventionNames': ['Drug: rodatristat ethyl 600 mg BID']}, {'type': 'EXPERIMENTAL', 'label': 'Rodatristat Ethyl 600 mg-Rodatristat Ethyl 600 mg', 'description': 'Subjects whose actual treatment group is Rodatristat ethyl two 600 mg in the double-blind phase (Main Study) and received Rodatristat ethyl two 600 mg tablets BID in the open-label phase', 'interventionNames': ['Drug: rodatristat ethyl 600 mg BID']}], 'interventions': [{'name': 'rodatristat ethyl 300 mg tablet BID', 'type': 'DRUG', 'description': 'rodatristat ethyl 300 mg tablet + matching placebo tablet twice daily on top of standard of care', 'armGroupLabels': ['Placebo-Rodatristat Ethyl 300 mg', 'Rodatristat Ethyl 300 mg BID', 'Rodatristat Ethyl 300 mg-Rodatristat Ethyl 300 mg']}, {'name': 'rodatristat ethyl 600 mg BID', 'type': 'DRUG', 'description': '2 rodatristat ethyl 300 mg tablets twice daily on top of standard of care', 'armGroupLabels': ['Placebo-Rodatristat Ethyl 600 mg', 'Rodatristat Ethyl 300 mg-Rodatristat Ethyl 600 mg', 'Rodatristat Ethyl 600 mg BID', 'Rodatristat Ethyl 600 mg-Rodatristat Ethyl 600 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '2 matching placebo tablets on top of standard of care', 'armGroupLabels': ['Placebo']}]}, 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