Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-25 @ 7:37 PM
Study NCT ID:
NCT00635232
Status:
COMPLETED
Last Update Posted:
2011-09-16
First Post:
2008-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study To Evaluate The Dose-Related Efficacy and Safety of PS433540 in Subjects With Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077405', 'term': 'Irbesartan'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013141', 'term': 'Spiro Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hzientek@ligand.com', 'phone': '858-550-7892', 'title': 'Director of Project Management', 'organization': 'Ligand Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The 800mg dose level was discontinued from further enrollment per protocol amendment due to findings from another PS433540 trial that suggested clinical benefit beyond 500mg was expected to be limited.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Irbesartan 300mg', 'description': 'Irbesartan 300 mg once daily', 'otherNumAtRisk': 58, 'otherNumAffected': 19, 'seriousNumAtRisk': 58, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Blinded Placebo Treatment', 'otherNumAtRisk': 59, 'otherNumAffected': 20, 'seriousNumAtRisk': 59, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'PS433540 200mg', 'description': 'PS433540 200mg once daily', 'otherNumAtRisk': 58, 'otherNumAffected': 10, 'seriousNumAtRisk': 58, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'PS433540 400mg', 'description': 'PS433540 400mg once daily', 'otherNumAtRisk': 58, 'otherNumAffected': 25, 'seriousNumAtRisk': 58, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'PS433540 800mg', 'description': 'PS433540 800mg once daily', 'otherNumAtRisk': 28, 'otherNumAffected': 17, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dermatitis Contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Eye Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Feces Discoloured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Haemoglobin abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hot Flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Injury, Poisoning and Procedural Complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 58, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Musculoskeletal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 58, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Respiratory Tract Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Stress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Tooth Abcess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Squamous cell carcinoma', 'notes': 'reported during the placebo run-in phase- subject not on active treatment at the time of report.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Mean Seated Systolic Blood Pressure (SBP) Following 12 Weeks of Treatment With PS433540 200 mg, 400 mg, 800 mg and Placebo.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Irbesartan 300mg'}, {'id': 'OG001', 'title': 'Placebo'}, {'id': 'OG002', 'title': 'PS433540 200mg'}, {'id': 'OG003', 'title': 'PS433540 400mg'}, {'id': 'OG004', 'title': 'PS433540 800mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.7', 'spread': '14.32', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '14.16', 'groupId': 'OG001'}, {'value': '-13.2', 'spread': '13.61', 'groupId': 'OG002'}, {'value': '-14.2', 'spread': '11.90', 'groupId': 'OG003'}, {'value': '-23.4', 'spread': '18.70', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary efficacy population was the Full Analysys Set (FAS) population= all randomized subjects who took at least one dose of the assigned study drug and had both baseline and post-baseline mean seated SBP. Both LOCF and observed-data set approach were performed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Seated Diastolic Blood Pressure (DBP) Following 12 Weeks of Treatment With PS433540 200 mg, 400 mg, 800 mg and Placebo.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Irbesartan 300mg'}, {'id': 'OG001', 'title': 'Placebo'}, {'id': 'OG002', 'title': 'PS433540 200mg'}, {'id': 'OG003', 'title': 'PS433540 400mg'}, {'id': 'OG004', 'title': 'PS433540 800mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.1', 'spread': '9.19', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '9.68', 'groupId': 'OG001'}, {'value': '-7.2', 'spread': '8.34', 'groupId': 'OG002'}, {'value': '-9.2', 'spread': '9.10', 'groupId': 'OG003'}, {'value': '-14.3', 'spread': '10.53', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Percentage of Patients Treated With Each Dose of PS433540 Who Achieved Blood Pressure Control, Defined as <140/90 mmHg, After 12 Weeks of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Irbesartan 300mg'}, {'id': 'OG001', 'title': 'Placebo'}, {'id': 'OG002', 'title': 'PS433540 200mg'}, {'id': 'OG003', 'title': 'PS433540 400mg'}, {'id': 'OG004', 'title': 'PS433540 800mg'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (LOCF)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Irbesartan 300mg', 'description': 'Irbesartan 300 mg once daily'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Blinded Placebo Treatment'}, {'id': 'FG002', 'title': 'PS433540 200mg', 'description': 'PS433540 200mg once daily'}, {'id': 'FG003', 'title': 'PS433540 400mg', 'description': 'PS433540 400mg once daily'}, {'id': 'FG004', 'title': 'PS433540 800mg', 'description': 'PS433540 800mg once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '59'}, {'groupId': 'FG002', 'numSubjects': '58'}, {'groupId': 'FG003', 'numSubjects': '58'}, {'groupId': 'FG004', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '55'}, {'groupId': 'FG003', 'numSubjects': '48'}, {'groupId': 'FG004', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '8'}]}]}], 'preAssignmentDetails': 'All subjects were weaned off all antihypertensive medication prior to be entered into a 4-week single-blind placebo run-in period. Subjects had to have eligible Seated systolic and diastolic BP measurements during the single-blind placebo run-in phase to be eligible for the double blind portion of the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '261', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Irbesartan 300mg', 'description': 'Irbesartan 300 mg once daily'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Blinded Placebo Treatment'}, {'id': 'BG002', 'title': 'PS433540 200mg', 'description': 'PS433540 200mg once daily'}, {'id': 'BG003', 'title': 'PS433540 400mg', 'description': 'PS433540 400mg once daily'}, {'id': 'BG004', 'title': 'PS433540 800mg', 'description': 'PS433540 800mg once daily'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '231', 'groupId': 'BG005'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '30', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.5', 'spread': '8.97', 'groupId': 'BG000'}, {'value': '54.2', 'spread': '8.12', 'groupId': 'BG001'}, {'value': '53.2', 'spread': '10.58', 'groupId': 'BG002'}, {'value': '53.4', 'spread': '10.71', 'groupId': 'BG003'}, {'value': '51.4', 'spread': '9.92', 'groupId': 'BG004'}, {'value': '52.9', 'spread': '9.66', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '123', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '138', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '261', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 261}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-12', 'studyFirstSubmitDate': '2008-03-06', 'resultsFirstSubmitDate': '2011-08-09', 'studyFirstSubmitQcDate': '2008-03-12', 'lastUpdatePostDateStruct': {'date': '2011-09-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-08-10', 'studyFirstPostDateStruct': {'date': '2008-03-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Mean Seated Systolic Blood Pressure (SBP) Following 12 Weeks of Treatment With PS433540 200 mg, 400 mg, 800 mg and Placebo.', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Mean Seated Diastolic Blood Pressure (DBP) Following 12 Weeks of Treatment With PS433540 200 mg, 400 mg, 800 mg and Placebo.', 'timeFrame': '12 weeks'}, {'measure': 'The Percentage of Patients Treated With Each Dose of PS433540 Who Achieved Blood Pressure Control, Defined as <140/90 mmHg, After 12 Weeks of Treatment.', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertension', 'High Blood Pressure'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn which doses of PS433540 should be given to patients with high blood pressure to lower their blood pressure. This study will also examine how safe PS433540 is when taken by patients with high blood pressure. Approximately 720 patients will be evaluated so that about 375 patients will be entered into the treatment phase of the study and be given PS433540.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females 18 - 70 years\n* Mean seated Systolic Blood Pressure (SBP) ≥ 140 mmHg and \\< 180 mmHg and mean seated Diastolic Blood Pressure (DBP) \\> 90 and \\< 109 mmHg at two consecutive qualifying visits (Visits 3/3.5 and Visit 4). The mean difference in DBP between the two consecutive qualifying visits must be ≤ 10 mmHg.\n* Women of child-bearing potential (WOCBP) must use two reliable forms of contraception if sexually active. Alternatively, female subjects must be postmenopausal (for at least 1 year).\n\nExclusion Criteria:\n\n* Subjects with serious disorders which may limit the ability to evaluate the efficacy or safety of PS433540, including cardiovascular (includes subjects who are known to have coronary artery disease), renal (including the absence of one kidney), pulmonary, hepatic, gastrointestinal (including clinically significant malabsorption), endocrine/metabolic, hematologic, neurologic and psychiatric diseases.\n* History of malignancy other than adequately treated basal cell or squamous cell skin cancer.\n* Subjects with a history of myocardial infarction or New York Heart Association (NYHA) class II-IV heart failure.\n* Subjects with a history of cerebrovascular accident or transient ischemic attack.\n* Subjects with clinically significant cardiac conduction defects, including second or third degree Atrioventricular Block (AV block), left bundle branch block, sick sinus syndrome, atrial fibrillation, atrial flutter, an accessory bypass tract, or any arrhythmia requiring medication.\n* Subjects with hemodynamically significant valvular disease.\n* Subjects with history of type 1 diabetes mellitus and subjects with a history of type 2 diabetes mellitus using antihyperglycemic medication (oral medication, insulin, or exenatide) are excluded.'}, 'identificationModule': {'nctId': 'NCT00635232', 'briefTitle': 'A Study To Evaluate The Dose-Related Efficacy and Safety of PS433540 in Subjects With Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ligand Pharmaceuticals'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo And Active-Controlled, Parallel Group Study To Evaluate The Dose-Related Efficacy And Safety Of PS433540 In Subjects With Hypertension', 'orgStudyIdInfo': {'id': 'PCO-C-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Irbesartan 300mg', 'description': 'Irbesartan 300 mg once daily', 'interventionNames': ['Drug: irbesartan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Blinded Placebo Treatment', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'PS433540 200mg', 'description': 'PS433540 200mg once daily', 'interventionNames': ['Drug: PS433540']}, {'type': 'EXPERIMENTAL', 'label': 'PS433540 400mg', 'description': 'PS433540 400mg once daily', 'interventionNames': ['Drug: PS433540']}, {'type': 'EXPERIMENTAL', 'label': 'PS433540 800mg', 'description': 'PS433540 800mg once daily', 'interventionNames': ['Drug: PS433540']}], 'interventions': [{'name': 'irbesartan', 'type': 'DRUG', 'otherNames': ['Avapro'], 'description': '300 mg (2 x 150 mg capsules) once daily for 12 weeks', 'armGroupLabels': ['Irbesartan 300mg']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo capsules once daily for 12 weeks', 'armGroupLabels': ['Placebo']}, {'name': 'PS433540', 'type': 'DRUG', 'description': '200 mg (2 x 100 mg capsules) once daily for 12 weeks', 'armGroupLabels': ['PS433540 200mg']}, {'name': 'PS433540', 'type': 'DRUG', 'description': '400 mg (4 x 100 mg capsules) once daily for 12 weeks', 'armGroupLabels': ['PS433540 400mg']}, {'name': 'PS433540', 'type': 'DRUG', 'description': '800 mg (8 x 100 mg capsules) once daily for 12 weeks', 'armGroupLabels': ['PS433540 800mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35128', 'city': 'Pell City', 'state': 'Alabama', 'country': 'United States', 'facility': 'Advanced Clinical Research 1000 Forrest Place Suite 2 Pell City', 'geoPoint': {'lat': 33.58621, 'lon': -86.28609}}, {'zip': '85282', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Premiere Pharmaceutical Research, LLC', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '85741', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Genova Clinical Research AZ', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Advanced Clinical Research Institute', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90620', 'city': 'Buena Park', 'state': 'California', 'country': 'United States', 'facility': 'Associated Pharmaceutical Research Center', 'geoPoint': {'lat': 33.86751, 'lon': -117.99812}}, {'zip': '95648', 'city': 'Lincoln', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Trials Research CA', 'geoPoint': {'lat': 38.89156, 'lon': -121.29301}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Long Beach Center for Clinical Research', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'National Research Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95825', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Superior Regional Research, LLC', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92780', 'city': 'Tustin', 'state': 'California', 'country': 'United States', 'facility': 'Orange County Research Center', 'geoPoint': {'lat': 33.74585, 'lon': -117.82617}}, {'zip': '91361', 'city': 'Westlake Village', 'state': 'California', 'country': 'United States', 'facility': 'Westlake Medical Center', 'geoPoint': {'lat': 34.14584, 'lon': -118.80565}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'Univ. 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'27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Peidmont Medical Research Associates', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Lindner Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43015', 'city': 'Delaware', 'state': 'Ohio', 'country': 'United States', 'facility': 'Delaware Smith Clinic', 'geoPoint': {'lat': 40.29867, 'lon': -83.06797}}, {'zip': '43302', 'city': 'Marion', 'state': 'Ohio', 'country': 'United States', 'facility': 'Smith Clinic', 'geoPoint': {'lat': 40.58867, 'lon': -83.12852}}, {'zip': '73103', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'COR Clinical Research, L.L.C', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19335', 'city': 'Downingtown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Brandywine Clinical Research Center', 'geoPoint': {'lat': 40.0065, 'lon': -75.70327}}, {'zip': '02904', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Hypertension & Nephrology Inc', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '75006', 'city': 'Carrollton', 'state': 'Texas', 'country': 'United States', 'facility': 'Punzi Medical Center', 'geoPoint': {'lat': 32.95373, 'lon': -96.89028}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Innovative Clinical Trials', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78258', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'IMED Research PA', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Hampton Roads Center for Clinical Research', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '53719', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Gemini Scientific LLC', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Rene Belder, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ligand Pharmaceuticals'}, {'name': 'Joel Neutel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orange County Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ligand Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}