Ignite Creation Date:
2025-12-26 @ 12:15 PM
Ignite Modification Date:
2025-12-26 @ 12:15 PM
Study NCT ID:
NCT05135000
Status:
TERMINATED
Last Update Posted:
2025-05-15
First Post:
2021-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of Efficacy and Safety of LTP001 in Pulmonary Arterial Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@Novartis.com', 'phone': '+ 1 862 778 8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 241 days.', 'eventGroups': [{'id': 'EG000', 'title': 'LTP001', 'description': 'Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 20, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 7, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Total', 'description': 'Total', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 27, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Rash pruritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}], 'seriousEvents': [{'term': 'Right ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Catheter site cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Bipolar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}, {'term': 'Pulmonary arterial hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Right Heard Catheterization Pulmonary Vascular Resistance (PVR) at Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LTP001', 'description': 'Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.175', 'spread': '254.0792', 'groupId': 'OG000'}, {'value': '-49.685', 'spread': '181.3745', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 25', 'description': 'PVR was defined as the resistance against blood flow from the pulmonary artery to the left atrium measured in dyn.s.cm-5', 'unitOfMeasure': 'dynes.sec.cm^-5', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Six Minute Walk Distance (6MWD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LTP001', 'description': 'Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks'}], 'classes': [{'title': 'Week 13 n=30,10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '42.45', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '29.34', 'groupId': 'OG001'}]}]}, {'title': 'Week 25 n=28,10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.4', 'spread': '44.36', 'groupId': 'OG000'}, {'value': '21.0', 'spread': '32.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 13 and 25', 'description': '6MWD test measures the distance that a patient can walk on a flat, hard surface in a period of 6 minutes', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Right Atrium (RA) Pressures at Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LTP001', 'description': 'Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'spread': '4.40', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 25', 'description': 'The Right Heart Catheterization (RHC) assessment was performed to assess several hemodynamic variables in pulmonary hypertension, including RA pressures.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pulmonary Capillary Wedge Pressure at Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LTP001', 'description': 'Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '3.66', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '2.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 25', 'description': 'Right heart catheterization (RHC) assessment was performed to assess several hemodynamic variables in pulmonary hypertension, including pulmonary capillary wedge pressure (PCWP).', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Pulmonary Artery Pressure at Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LTP001', 'description': 'Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '8.55', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '5.61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 25', 'description': 'Right heart catheterization (RHC) assessment was performed to assess several hemodynamic variables in pulmonary hypertension, including pulmonary artery pressure.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Average Cardiac Output (CO) at Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LTP001', 'description': 'Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.067', 'spread': '1.0772', 'groupId': 'OG000'}, {'value': '0.493', 'spread': '0.9075', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 25', 'description': 'Right heart catheterization (RHC) assessment was performed to assess several hemodynamic variables in pulmonary hypertension, including cardiac output (CO).', 'unitOfMeasure': 'liters per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fractional Area Change (FAC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LTP001', 'description': 'Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks'}], 'classes': [{'title': 'Week 5 n=31,9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.35', 'spread': '6.944', 'groupId': 'OG000'}, {'value': '0.92', 'spread': '5.622', 'groupId': 'OG001'}]}]}, {'title': 'Week 13 n=29,10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.19', 'spread': '6.424', 'groupId': 'OG000'}, {'value': '2.62', 'spread': '4.417', 'groupId': 'OG001'}]}]}, {'title': 'Week 25 n=26,8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.85', 'spread': '5.412', 'groupId': 'OG000'}, {'value': '-1.45', 'spread': '7.532', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 5, 13, and 25', 'description': 'Key right ventricular (RV) function endpoints such as RV fractional area change (RV FAC) were assessed with echocardiography.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Peak Velocity of Excursion (RV S')", 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LTP001', 'description': 'Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks'}], 'classes': [{'title': 'Week 5 n=33,11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '1.50', 'groupId': 'OG001'}]}]}, {'title': 'Week 13 n=32,11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '2.38', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '1.63', 'groupId': 'OG001'}]}]}, {'title': 'Week 25 n=26,9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '2.28', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '3.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 5, 13, and 25', 'description': "Key right ventricular (RV) function per echocardiography. The terms Tricuspid Annular Systolic Velocity (TASV) and Peak Velocity of Excursion (RV S') are synonymous in echocardiography to describe the peak systolic velocity of the lateral tricuspid annulus. Including both TASV and RV S' as separate secondary endpoints was an oversight in the protocol as the data, calculation, and analyses for both (TASV and RV S') are identical. Therefore, the TASV and RV S' data in this results disclosure are the same.", 'unitOfMeasure': 'centimeters per second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LTP001', 'description': 'Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks'}], 'classes': [{'title': 'Week 5 n=33,11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.061', 'spread': '0.3181', 'groupId': 'OG000'}, {'value': '0.042', 'spread': '0.3383', 'groupId': 'OG001'}]}]}, {'title': 'Week 13 n=31,11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.026', 'spread': '0.2594', 'groupId': 'OG000'}, {'value': '0.100', 'spread': '0.2933', 'groupId': 'OG001'}]}]}, {'title': 'Week 25 n=27,9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.015', 'spread': '0.3697', 'groupId': 'OG000'}, {'value': '-0.067', 'spread': '0.2121', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 5, 13, and 25', 'description': 'Key right ventricular (RV) function endpoints such as tricuspid annular plane systolic excursion (TAPSE) were assessed with echocardiography.', 'unitOfMeasure': 'centimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tricuspid Annular Systolic Velocity (TASV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LTP001', 'description': 'Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks'}], 'classes': [{'title': 'Week 5 n=33,11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '1.50', 'groupId': 'OG001'}]}]}, {'title': 'Week 13 n=32,11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '2.38', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '1.63', 'groupId': 'OG001'}]}]}, {'title': 'Week 25 n=26,9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '2.28', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '3.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 5, 13 and 25', 'description': 'Key right ventricular (RV) function endpoints such as tricuspid annular systolic velocity (TASV) were assessed with echocardiography.', 'unitOfMeasure': 'centimeters per second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EmPHasis-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LTP001', 'description': 'Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks'}], 'classes': [{'title': 'Week 13 n=21,9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.490', 'spread': '5.7108', 'groupId': 'OG000'}, {'value': '-3.622', 'spread': '3.1712', 'groupId': 'OG001'}]}]}, {'title': 'Week 25 n=17,9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.972', 'spread': '8.7643', 'groupId': 'OG000'}, {'value': '-3.000', 'spread': '4.2961', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 13 and 25', 'description': "emPHasis-10 is a questionnaire with 10 questions designed to determine how pulmonary hypertension affects a participant's life. Each item is scored on a scale of 0 to 5, with a total score ranging from 0 to 50. A higher score indicates worse quality of life.", 'unitOfMeasure': 'score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LTP001', 'description': 'Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks'}], 'classes': [{'title': 'Week 13', 'categories': [{'measurements': [{'value': '-1.452', 'spread': '6.3897', 'groupId': 'OG000'}, {'value': '-3.545', 'spread': '3.2693', 'groupId': 'OG001'}]}]}, {'title': 'Week 25', 'categories': [{'measurements': [{'value': '-0.680', 'spread': '5.7304', 'groupId': 'OG000'}, {'value': '-4.220', 'spread': '6.1990', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 13 and 25', 'description': 'PAH-SYMPACT is a questionnaire used to assess pulmonary arterial hypertension symptoms and their impact. Individual item scores range from 0 to 4. Total score is calculated as the sum of the scores for the individual items divided by the number of items. A higher score indicates more severe symptoms/impacts.', 'unitOfMeasure': 'score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Blood Concentrations (Cmax) for LTP001', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LTP001', 'description': 'Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.6', 'spread': '58.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.2', 'spread': '54.7', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 and Week 25 at 15, 45, and 120 minutes post-dose', 'description': 'The maximum (peak) observed blood drug concentration after single dose administration.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) analysis set included all participants with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received any study drug, and without protocol deviations that impacted PK data.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Blood Concentrations (Tmax) of LTP001', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LTP001', 'description': 'Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.05', 'spread': '56.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.979', 'spread': '68.8', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 and Week 25 at 15, 45, and 120 minutes post-dose', 'description': 'The time to reach maximum (peak) blood drug concentration after single dose administration.', 'unitOfMeasure': 'hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) analysis set included all participants with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received any study drug, and without protocol deviations that impacted PK data.'}, {'type': 'SECONDARY', 'title': 'Time to Clinical Worsening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LTP001', 'description': 'Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '211.0', 'comment': 'The upper limit of 95% CI was not calculable due to an insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '174.0', 'upperLimit': 'NA'}, {'value': '175.0', 'comment': 'The upper limit of 95% CI was not calculable due to an insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': '174.0', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.6843', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.7', 'ciLowerLimit': '0.2', 'ciUpperLimit': '2.8', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to approximately 30 weeks', 'description': 'Time to any of the following:\n\n* Death\n* Hospital stay greater than 24 hours due to worsening of pulmonary arterial hypertension\n* Worsening of PAH resulting in need for lung transplantation or balloon atrial septostomy\n* Initiation of parenteral prostanoid therapy, initiation of oxygen therapy, initiation of any other pulmonary arterial hypertension-specific therapies or need for increase of diuretics for more than 4 weeks due to worsening of pulmonary arterial hypertension\n* Significant drop in six minute walk distance', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data. Participants without the event were considered as censored at the end of the time at risk.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in N-terminal Fragment of the Prohormone B-type Natriuretic Peptide (NT-ProBNP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LTP001', 'description': 'Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '4.609', 'spread': '52.9047', 'groupId': 'OG000'}, {'value': '-7.918', 'spread': '21.9731', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 29', 'description': 'NT-proBNP is a blood biomarker to assess right ventricular distress.', 'unitOfMeasure': 'picomoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with a relevant impact on PD data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LTP001', 'description': 'Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'A total of 56 participants were screened for the study. Out of these, 47 participants were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'LTP001', 'description': 'Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.3', 'spread': '13.03', 'groupId': 'BG000'}, {'value': '45.3', 'spread': '13.78', 'groupId': 'BG001'}, {'value': '45.3', 'spread': '13.07', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '18 - <65', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': '65 - <85', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaska', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-01', 'size': 6488422, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-03-18T10:49', 'hasProtocol': True}, {'date': '2024-06-05', 'size': 1737594, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-03-18T10:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'whyStopped': 'Sponsor Decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-01', 'studyFirstSubmitDate': '2021-11-16', 'resultsFirstSubmitDate': '2025-03-18', 'studyFirstSubmitQcDate': '2021-11-16', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-01', 'studyFirstPostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Right Heard Catheterization Pulmonary Vascular Resistance (PVR) at Week 25', 'timeFrame': 'Baseline, Week 25', 'description': 'PVR was defined as the resistance against blood flow from the pulmonary artery to the left atrium measured in dyn.s.cm-5'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Six Minute Walk Distance (6MWD)', 'timeFrame': 'Baseline, Weeks 13 and 25', 'description': '6MWD test measures the distance that a patient can walk on a flat, hard surface in a period of 6 minutes'}, {'measure': 'Change From Baseline in Right Atrium (RA) Pressures at Week 25', 'timeFrame': 'Baseline, Week 25', 'description': 'The Right Heart Catheterization (RHC) assessment was performed to assess several hemodynamic variables in pulmonary hypertension, including RA pressures.'}, {'measure': 'Change From Baseline in Pulmonary Capillary Wedge Pressure at Week 25', 'timeFrame': 'Baseline, Week 25', 'description': 'Right heart catheterization (RHC) assessment was performed to assess several hemodynamic variables in pulmonary hypertension, including pulmonary capillary wedge pressure (PCWP).'}, {'measure': 'Change From Baseline in Mean Pulmonary Artery Pressure at Week 25', 'timeFrame': 'Baseline, Week 25', 'description': 'Right heart catheterization (RHC) assessment was performed to assess several hemodynamic variables in pulmonary hypertension, including pulmonary artery pressure.'}, {'measure': 'Change From Baseline in Average Cardiac Output (CO) at Week 25', 'timeFrame': 'Baseline, Week 25', 'description': 'Right heart catheterization (RHC) assessment was performed to assess several hemodynamic variables in pulmonary hypertension, including cardiac output (CO).'}, {'measure': 'Change From Baseline in Fractional Area Change (FAC)', 'timeFrame': 'Baseline, Weeks 5, 13, and 25', 'description': 'Key right ventricular (RV) function endpoints such as RV fractional area change (RV FAC) were assessed with echocardiography.'}, {'measure': "Change From Baseline in Peak Velocity of Excursion (RV S')", 'timeFrame': 'Baseline, Weeks 5, 13, and 25', 'description': "Key right ventricular (RV) function per echocardiography. The terms Tricuspid Annular Systolic Velocity (TASV) and Peak Velocity of Excursion (RV S') are synonymous in echocardiography to describe the peak systolic velocity of the lateral tricuspid annulus. Including both TASV and RV S' as separate secondary endpoints was an oversight in the protocol as the data, calculation, and analyses for both (TASV and RV S') are identical. Therefore, the TASV and RV S' data in this results disclosure are the same."}, {'measure': 'Change From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE)', 'timeFrame': 'Baseline, Weeks 5, 13, and 25', 'description': 'Key right ventricular (RV) function endpoints such as tricuspid annular plane systolic excursion (TAPSE) were assessed with echocardiography.'}, {'measure': 'Change From Baseline in Tricuspid Annular Systolic Velocity (TASV)', 'timeFrame': 'Baseline, Weeks 5, 13 and 25', 'description': 'Key right ventricular (RV) function endpoints such as tricuspid annular systolic velocity (TASV) were assessed with echocardiography.'}, {'measure': 'Change From Baseline in EmPHasis-10', 'timeFrame': 'Baseline, Weeks 13 and 25', 'description': "emPHasis-10 is a questionnaire with 10 questions designed to determine how pulmonary hypertension affects a participant's life. Each item is scored on a scale of 0 to 5, with a total score ranging from 0 to 50. A higher score indicates worse quality of life."}, {'measure': 'Change From Baseline in Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT)', 'timeFrame': 'Baseline, Weeks 13 and 25', 'description': 'PAH-SYMPACT is a questionnaire used to assess pulmonary arterial hypertension symptoms and their impact. Individual item scores range from 0 to 4. Total score is calculated as the sum of the scores for the individual items divided by the number of items. A higher score indicates more severe symptoms/impacts.'}, {'measure': 'Maximum Observed Blood Concentrations (Cmax) for LTP001', 'timeFrame': 'Day 1 and Week 25 at 15, 45, and 120 minutes post-dose', 'description': 'The maximum (peak) observed blood drug concentration after single dose administration.'}, {'measure': 'Time to Reach Maximum Blood Concentrations (Tmax) of LTP001', 'timeFrame': 'Day 1 and Week 25 at 15, 45, and 120 minutes post-dose', 'description': 'The time to reach maximum (peak) blood drug concentration after single dose administration.'}, {'measure': 'Time to Clinical Worsening', 'timeFrame': 'Baseline up to approximately 30 weeks', 'description': 'Time to any of the following:\n\n* Death\n* Hospital stay greater than 24 hours due to worsening of pulmonary arterial hypertension\n* Worsening of PAH resulting in need for lung transplantation or balloon atrial septostomy\n* Initiation of parenteral prostanoid therapy, initiation of oxygen therapy, initiation of any other pulmonary arterial hypertension-specific therapies or need for increase of diuretics for more than 4 weeks due to worsening of pulmonary arterial hypertension\n* Significant drop in six minute walk distance'}, {'measure': 'Change From Baseline in N-terminal Fragment of the Prohormone B-type Natriuretic Peptide (NT-ProBNP)', 'timeFrame': 'Baseline to Week 29', 'description': 'NT-proBNP is a blood biomarker to assess right ventricular distress.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulmonary Hypertension'], 'conditions': ['Pulmonary Arterial Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to explore the efficacy and safety of LTP001 in participants with pulmonary arterial hypertension (PAH) to determine if LTP001 had an adequate clinical profile to warrant further clinical development in this indication.', 'detailedDescription': 'This study was a non-confirmatory, randomized, participant- and investigator-blinded, placebo controlled trial evaluating the efficacy and safety of LTP001 on top of standard of care in participants with PAH.\n\nThe study included a screening period of up to 8 weeks, followed by a 24-week treatment phase with daily dosing and visits scheduled approximately every 4 weeks. One follow-up visit, which also served as the end-of-study visit, was conducted approximately 30 days after the conclusion of the treatment phase. The total duration of the study, from the beginning of the screening period to the end-of-study visit, was approximately 37 weeks.\n\nA total of 44 participants were planned to be randomized in a 3:1 ratio to receive either LTP001 6 mg or placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of PAH belonging to one of the following subgroups of the Clinical Classification Group 1 (WHO):\n\n * participants with idiopathic pulmonary arterial hypertension (IPAH)\n * Hereditary pulmonary arterial hypertension\n * Congenital heart disease (surgically repaired at least 12 months prior to screening)\n * drug or toxin induced (for example, anorexigen, or methamphetamine use).\n* Resting mean pulmonary arterial pressure (mPAP) \\> 25 mmHg; pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure \\< 15 mmHg, as determined by right heart catheterization within 20 days of randomization.\n* Pulmonary Vascular Resistance \\> 6 Wood units (480 dynes s/cm-5), as determined by right heart catheterization within 20 days of randomization.\n* WHO Functional Class II-III\n* 6MWD must be between 150 and 550 m (inclusive). The qualifying test needs to be within 20 days of randomization. To meet the above criterion additional six minute walk test (6MWT) may be performed up to a maximum of 3 tests in total prior to dosing; the minimal time difference between two tests should be at least 4 h.\n\n * Standard of care therapy which is stable at least 6 weeks prior to RHC and qualifying 6MWT assessment within 20 days of randomization. Standard of care includes one or more of the following treatments:\n * prostacyclin analogues and receptor agonists (if I.V., dose adjustments must be within 20% of initial stable dose)\n * endothelin receptor antagonists (ERAs)\n * phosphodiesterase type 5 inhibitors (PDE5i)\n * soluble guanylate cyclase (sGC) stimulators\n\nExclusion Criteria:\n\n* Participants with pulmonary hypertension (PH) in the Clinical Classification Groups 2-5 (WHO), and any PAH Group 1 subgroups not covered by Inclusion Criterion #4.\n* Participants with a history of left sided heart disease, chronic left sided heart failure, congenital or acquired valvular disease compromising left ventricular function and/or pulmonary venous hypertension or symptomatic coronary disease (non-symptomatic, revascularized coronary artery disease would be acceptable).\n* Participants with obstructive lung disease defined as: FEV1/FVC \\< 60% and FEV1 \\< 60% of predicted value after bronchodilator administration as well as participants with moderate or severe restrictive lung disease: Total Lung Capacity \\< 70% of predicted value. Testing must have occurred within 24months of screening. If historical testing is not available, then lung function testing must be conducted during the screening period.\n* Acute or chronic impairment (other than dyspnea), which would limit the ability to comply with study requirements, including interference with physical activity and execution of study procedures such as 6MWT (e.g., angina pectoris, claudication, musculoskeletal disorder, multiple sclerosis, need for walking aids).'}, 'identificationModule': {'nctId': 'NCT05135000', 'briefTitle': 'Study of Efficacy and Safety of LTP001 in Pulmonary Arterial Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Participant- and Investigator-blinded, Placebo-controlled Study to Investigate Efficacy, Safety, and Tolerability of LTP001 in Participants With Pulmonary Arterial Hypertension', 'orgStudyIdInfo': {'id': 'CLTP001A12201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LTP001', 'description': 'Participants received LTP001, 6 mg, oral capsules, once daily in the morning for approximately 24 weeks', 'interventionNames': ['Drug: LTP001']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received LTP001 placebo capsules matching LTP001 orally once daily in the morning for approximately 24 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LTP001', 'type': 'DRUG', 'description': 'LTP001, 6 mg, was administered orally once daily in the morning', 'armGroupLabels': ['LTP001']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo to LTP001 was administered once daily in the morning', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85206', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pulmonary Associates PA', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical Univ of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': 'C1025ABI', 'city': 'Caba', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Novartis Investigative Site'}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '1081 HV', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '31 202', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '91-347', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '50-556', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '29010', 'city': 'Málaga', 'state': 'Andalusia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '08036', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'S10 2JF', 'city': 'Sheffield', 'state': 'South Yorkshire', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'SW3 6PH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}