Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-28 @ 12:34 AM
Study NCT ID:
NCT00441350
Status:
COMPLETED
Last Update Posted:
2021-07-28
First Post:
2007-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Olmesartan/HCTZ 40/12.5 mg Combination Therapy Versus Olmesartan Medoxomil 40 mg Monotherapy in Essential 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': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'acapriati@menarini-ricerche.it', 'phone': '+39 055 5680', 'title': 'Angela Capriati, MD PhD - Global Director Clinical Sciences', 'phoneExt': '9990', 'organization': 'Menarini Group'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The study consisted of two sequential phases A and B of 8 weeks duration each.', 'description': 'Adverse events were recorded for all patients who started each of the 2 treatment groups in phase A, as well as in all those patients who, as per their allocation, started the treatment groups in phase B.', 'eventGroups': [{'id': 'EG000', 'title': 'Phase B OM/HCTZ 40/12.5 mg Non-responders', 'description': 'Phase B (second double-blind treatment phase, 8 weeks duration):\n\nNon-responders to OM/HCTZ 40/12.5 mg treatment were to be up- titrated to OM/HCTZ 40/25 mg.', 'otherNumAtRisk': 188, 'deathsNumAtRisk': 188, 'otherNumAffected': 9, 'seriousNumAtRisk': 188, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Phase B OM/HCTZ 40/12.5 mg Responders', 'description': 'Phase B (second double-blind treatment phase, 8 weeks duration):\n\nResponders to OM/HCTZ 40/12.5 mg treatment were to continue treatment with OM/HCTZ 40/12.5 mg.', 'otherNumAtRisk': 336, 'deathsNumAtRisk': 336, 'otherNumAffected': 16, 'seriousNumAtRisk': 336, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Phase B OM 40 mg Non-responders', 'description': 'Phase B (second double-blind treatment phase, 8 weeks duration):\n\nNon-responders to OM 40 mg treatment were to be up-titrated to OM/HCTZ 40/12.5 mg.', 'otherNumAtRisk': 139, 'deathsNumAtRisk': 139, 'otherNumAffected': 6, 'seriousNumAtRisk': 139, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Phase B OM 40 mg Responders', 'description': 'Phase B (second double-blind treatment phase, 8 weeks duration):\n\nResponders to OM 40 mg treatment were to continue treatment with OM 40 mg.', 'otherNumAtRisk': 129, 'deathsNumAtRisk': 129, 'otherNumAffected': 8, 'seriousNumAtRisk': 129, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Phase A OM/HCTZ 40/12.5 mg', 'description': 'Phase A (first double-blind treatment phase, 8 weeks duration):\n\nArm 2: OM/HCTZ 40/12.5 mg tablet o.d.', 'otherNumAtRisk': 561, 'deathsNumAtRisk': 561, 'otherNumAffected': 41, 'seriousNumAtRisk': 561, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG005', 'title': 'Phase A OM 40 mg', 'description': 'Phase A (first double-blind treatment phase, 8 weeks duration):\n\nArm 1: OM 40 mg tablet o.d.', 'otherNumAtRisk': 285, 'deathsNumAtRisk': 285, 'otherNumAffected': 19, 'seriousNumAtRisk': 285, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 561, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 561, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 285, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 561, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 139, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 561, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 285, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 129, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 561, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 561, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 561, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 561, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 285, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 129, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 561, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 285, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 139, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 129, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 561, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG005', 'numAtRisk': 285, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Anal fissure', 'notes': 'Worsening and surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 561, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 561, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 561, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 561, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 561, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 561, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ischaemic cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 561, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 561, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Brain contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 561, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 561, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 561, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 561, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 561, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 561, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 561, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 561, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 561, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 561, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Parotid abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 561, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 285, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Erysipeloid', 'notes': 'Erysipel B / Erysipel Crus Left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 188, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 561, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 285, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'dBP Change After 8 Weeks Phase A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '556', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OM 40', 'description': 'Olmesartanmedoxomil (OM)40 mg tablets. OM 40: Initially patients were to be treated with Olmesartanmedoxomil (OM)40 mg tablets once daily for 8 weeks.'}, {'id': 'OG001', 'title': 'OM/HCTZ 40/12.5', 'description': 'Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets. OM/HCTZ 40/12.5: Initially patients were to be treated with Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets once daily for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.8', 'spread': '9.71', 'groupId': 'OG000'}, {'value': '-18.9', 'spread': '9.32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Eight weeks', 'description': 'Reduction in Mean Trough Sitting dBP (mmHg) from Baseline (Week 0) to Week 8', 'unitOfMeasure': 'mmHG', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'sBP Change After 8 Weeks Phase A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '556', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OM 40', 'description': 'Olmesartanmedoxomil (OM)40 mg tablets. OM 40: Initially patients were to be treated with Olmesartanmedoxomil (OM)40 mg tablets once daily for 8 weeks.'}, {'id': 'OG001', 'title': 'OM/HCTZ 40/12.5', 'description': 'Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets. OM/HCTZ 40/12.5: Initially patients were to be treated with Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets once daily for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-26.5', 'spread': '14.56', 'groupId': 'OG000'}, {'value': '-31.9', 'spread': '14.76', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Eight weeks', 'description': 'Reduction in Mean Trough Sitting sBP (mmHg) from Baseline (Week 0) to Week 8', 'unitOfMeasure': 'mmHG', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'dBP Change After 8 Weeks Phase B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '336', 'groupId': 'OG002'}, {'value': '187', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'OM 40 mg Responders', 'description': 'Phase B (second double-blind treatment phase, 8 weeks duration):\n\nResponders to OM 40 mg treatment were to continue treatment with OM 40 mg.'}, {'id': 'OG001', 'title': 'OM 40 mg Non-responders', 'description': 'Phase B (second double-blind treatment phase, 8 weeks duration):\n\nNon-responders to OM 40 mg treatment were to be up-titrated to OM/HCTZ 40/12.5 mg.'}, {'id': 'OG002', 'title': 'OM/HCTZ 40/12.5 mg Responders', 'description': 'Phase B (second double-blind treatment phase, 8 weeks duration):\n\nResponders to OM/HCTZ 40/12.5 mg treatment were to continue treatment with OM/HCTZ 40/12.5 mg.'}, {'id': 'OG003', 'title': 'OM/HCTZ 40/12.5 mg Non-responders', 'description': 'Phase B (second double-blind treatment phase, 8 weeks duration):\n\nNon-responders to OM/HCTZ 40/12.5 mg treatment were to be up- titrated to OM/HCTZ 40/25 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'spread': '6.95', 'groupId': 'OG000'}, {'value': '-9.3', 'spread': '7.91', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '6.68', 'groupId': 'OG002'}, {'value': '-8.0', 'spread': '8.56', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Eight weeks', 'description': 'Reduction in trough sitting diastolic blood pressure after 8 weeks of additional treatment, depending on Phase A treatment and outcome (responder/non-responder).', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'sBP Change After 8 Weeks Phase B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '336', 'groupId': 'OG002'}, {'value': '187', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'OM 40 mg Responders', 'description': 'Phase B (second double-blind treatment phase, 8 weeks duration):\n\nResponders to OM 40 mg treatment were to continue treatment with OM 40 mg.'}, {'id': 'OG001', 'title': 'OM 40 mg Non-responders', 'description': 'Phase B (second double-blind treatment phase, 8 weeks duration):\n\nNon-responders to OM 40 mg treatment were to be up-titrated to OM/HCTZ 40/12.5 mg.'}, {'id': 'OG002', 'title': 'OM/HCTZ 40/12.5 mg Responders', 'description': 'Phase B (second double-blind treatment phase, 8 weeks duration):\n\nResponders to OM/HCTZ 40/12.5 mg treatment were to continue treatment with OM/HCTZ 40/12.5 mg.'}, {'id': 'OG003', 'title': 'OM/HCTZ 40/12.5 mg Non-responders', 'description': 'Phase B (second double-blind treatment phase, 8 weeks duration):\n\nNon-responders to OM/HCTZ 40/12.5 mg treatment were to be up- titrated to OM/HCTZ 40/25 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'spread': '6.95', 'groupId': 'OG000'}, {'value': '-12.4', 'spread': '11.64', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '9.32', 'groupId': 'OG002'}, {'value': '-12.1', 'spread': '12.69', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Eight weeks', 'description': 'Reduction in trough sitting systolic blood pressure after 8 weeks of additional treatment, depending on Phase A treatment and outcome (responder/non-responder).', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase A/OM 40', 'description': 'Olmesartanmedoxomil (OM)40 mg tablets. OM 40: Initially patients were to be treated with Olmesartanmedoxomil (OM)40 mg tablets once daily for 8 weeks. After 8 weeks non-responders were to be uptitrated to OM/HCTZ 40/12.5 mg and responders remained on the previous therapy for further 8 weeks.'}, {'id': 'FG001', 'title': 'Phase A/OM/HCTZ 40/12.5', 'description': 'Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets. OM/HCTZ 40/12.5: Initially patients were to be treated with Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets once daily for 8 weeks. After 8 weeks non-responders were to be uptitrated to OM/HCTZ 40/25 mg and responders remained on the previous therapy for further 8 weeks.'}, {'id': 'FG002', 'title': 'Phase B/ OM 40 mg Responders', 'description': 'Phase B (second double-blind treatment phase, 8 weeks duration):\n\nResponders to OM 40 mg treatment were to continue treatment with OM 40 mg.'}, {'id': 'FG003', 'title': 'Phase B/ OM 40 mg Non-responder', 'description': 'Phase B (second double-blind treatment phase, 8 weeks duration):\n\nNon-responders to OM 40 mg treatment were to be up-titrated to OM/HCTZ 40/12.5 mg.'}, {'id': 'FG004', 'title': 'Phase B OM/HCTZ 40/12.5 mg Responders', 'description': 'Phase B (second double-blind treatment phase, 8 weeks duration):\n\nResponders to OM/HCTZ 40/12.5 mg treatment were to continue treatment with OM/HCTZ 40/12.5 mg.'}, {'id': 'FG005', 'title': 'Phase B/ OM/HCTZ 40/12.5 mg Non-responders', 'description': 'Phase B (second double-blind treatment phase, 8 weeks duration):\n\nNon-responders to OM/HCTZ 40/12.5 mg treatment were to be up- titrated to OM/HCTZ 40/25 mg.'}], 'periods': [{'title': 'Phase A: Randomization to Week 8', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '285'}, {'groupId': 'FG001', 'numSubjects': '561'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '268'}, {'groupId': 'FG001', 'numSubjects': '524'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Phase B: Week 8 to Week 16', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '129'}, {'groupId': 'FG003', 'numSubjects': '139'}, {'groupId': 'FG004', 'numSubjects': '336'}, {'groupId': 'FG005', 'numSubjects': '188'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '128'}, {'groupId': 'FG003', 'numSubjects': '137'}, {'groupId': 'FG004', 'numSubjects': '333'}, {'groupId': 'FG005', 'numSubjects': '186'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'Participants who completed the arms OM 40 mg and OM/HCTZ 40/12.5 mg, respectively in Phase A are the same ones who started, depending on being a responder or non-responder in the arms of Phase B continuing with OM 40 mg and OM/HCTZ 40/12.5 mg or uptitration to OM/HCTZ 40/12.5 mg and OM/HCTZ 40/25, respectively of Phase B.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'BG000'}, {'value': '561', 'groupId': 'BG001'}, {'value': '846', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'OM 40', 'description': 'Olmesartanmedoxomil (OM)40 mg tablets.\n\nOM 40: Initially patients were to be treated with Olmesartanmedoxomil (OM)40 mg tablets once daily for 8 weeks. After 8 weeks non-responders were to be uptitrated to OM/HCTZ 40/12.5 mg and responders remained on the previous therapy for further 8 weeks.'}, {'id': 'BG001', 'title': 'OM/HCTZ 40/12.5', 'description': 'Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets.\n\nOM/HCTZ 40/12.5: Initially patients were to be treated with Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets once daily for 8 weeks. After 8 weeks non-responders were to be uptitrated to OM/HCTZ 40/25 mg and responders remained on the previous therapy for further 8 weeks.'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '211', 'groupId': 'BG000'}, {'value': '454', 'groupId': 'BG001'}, {'value': '665', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '181', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.0', 'spread': '11.46', 'groupId': 'BG000'}, {'value': '55.5', 'spread': '10.57', 'groupId': 'BG001'}, {'value': '55.6', 'spread': '10.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '267', 'groupId': 'BG001'}, {'value': '395', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '157', 'groupId': 'BG000'}, {'value': '294', 'groupId': 'BG001'}, {'value': '451', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Trough Sitting dBP', 'classes': [{'categories': [{'measurements': [{'value': '104.5', 'spread': '4.0', 'groupId': 'BG000'}, {'value': '104.6', 'spread': '4.2', 'groupId': 'BG001'}, {'value': '104.6', 'spread': '4.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Sitting diastolic blood pressure at baseline', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Trough Sitting sBP', 'classes': [{'categories': [{'measurements': [{'value': '168.0', 'spread': '7.7', 'groupId': 'BG000'}, {'value': '168.5', 'spread': '8.4', 'groupId': 'BG001'}, {'value': '168.3', 'spread': '8.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Sitting systolic blood pressure', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '29.64', 'spread': '4.8', 'groupId': 'BG000'}, {'value': '29.17', 'spread': '4.665', 'groupId': 'BG001'}, {'value': '29.35', 'spread': '4.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg.m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1004}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-08', 'studyFirstSubmitDate': '2007-02-27', 'resultsFirstSubmitDate': '2021-05-06', 'studyFirstSubmitQcDate': '2007-02-27', 'lastUpdatePostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-08', 'studyFirstPostDateStruct': {'date': '2007-02-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'dBP Change After 8 Weeks Phase A', 'timeFrame': 'Eight weeks', 'description': 'Reduction in Mean Trough Sitting dBP (mmHg) from Baseline (Week 0) to Week 8'}, {'measure': 'sBP Change After 8 Weeks Phase A', 'timeFrame': 'Eight weeks', 'description': 'Reduction in Mean Trough Sitting sBP (mmHg) from Baseline (Week 0) to Week 8'}], 'secondaryOutcomes': [{'measure': 'dBP Change After 8 Weeks Phase B', 'timeFrame': 'Eight weeks', 'description': 'Reduction in trough sitting diastolic blood pressure after 8 weeks of additional treatment, depending on Phase A treatment and outcome (responder/non-responder).'}, {'measure': 'sBP Change After 8 Weeks Phase B', 'timeFrame': 'Eight weeks', 'description': 'Reduction in trough sitting systolic blood pressure after 8 weeks of additional treatment, depending on Phase A treatment and outcome (responder/non-responder).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '20593911', 'type': 'DERIVED', 'citation': 'Fogari R, Taddei S, Holm-Bentzen M, Baszak J, Melani L, Schumacher K. Efficacy and safety of olmesartan medoxomil 40 mg/hydrochlorothiazide 12.5 mg combination therapy versus olmesartan medoxomil 40 mg monotherapy in patients with moderate to severe hypertension: a randomized, double-blind, parallel-group, multicentre, multinational, phase III study. Clin Drug Investig. 2010;30(9):581-97. doi: 10.2165/11536710-000000000-00000.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study was to assess the anti-hypertensive effect of OM/HCTZ 40/12.5 mg combination therapy compared to OM 40 mg monotherapy in lowering sitting diastolic BP in hypertensive patients after 8 weeks of double-blind treatment.\n\nThe study consisted of two sequential phases of 8 weeks duration each:\n\nDuring the first phase, OM 40 mg monotherapy was compared with OM/HCTZ 40/12.5 mg in order to evaluate the additional benefit of OM/HCTZ 40/12.5 mg in the treatment of essential moderate to severe hypertension.\n\nDuring the second phase, patients whose BP proved to be insufficiently controlled by the OM 40 mg monotherapy were to start OM/HCTZ 40/12.5 mg combination therapy while patients whose BP proved to be insufficiently controlled by the OM/HCTZ 40/12.5 mg combination were to be up-titrated to the OM/HCTZ 40/25 mg combination to evaluate the additional benefit of the up-titrated combination.\n\nThe study was be conducted by qualified and experienced personnel with adherence to GCP, current guidelines on the design of studies in hypertension, the applicable regulatory requirements and the ethical principles based on the Declaration of Helsinki.', 'detailedDescription': 'Methodology:\n\nAfter the signature of the informed consent, patients were screened for eligibility and eligible patients entered into a pre-randomisation period consisting of a taper-off phase of approximately 1-2 weeks (during which patients treated for hypertension were to discontinue their antihypertensive therapy) followed by a 2-week single-blind placebo run-in phase (Visit 1). After conclusion of the placebo run-in phase (Visit 2), eligible patients were randomised to the double-blind active treatment period which consisted of two phases:\n\nFirst double-blind treatment phase (Phase A, from Randomisation to Week 8):\n\nEligible patients with mean sitting sBP ≥ 160 and ≤ 200 mmHg and dBP ≥ 100 mmHg and ≤ 120 mmHg were randomised in a 1:2 ratio to receive either OM 40 mg or OM/HCTZ 40/12.5 mg for a total of 8 weeks of treatment (Phase A). Study visits were held after 4 and 8 weeks of double-blind active treatment (Visit 3 and 4, respectively). After 8 weeks (Visit 4), patients reaching the BP goal of \\< 140/90 mmHg or \\< 130/80 mmHg for diabetics were considered as responders. All patients (responders and non-responders) then entered into the titration phase of the study (Phase B):\n\nSecond double-blind treatment phase/titration phase (Phase B, from Week 8 to Week 16):\n\nTreatment assignment in the second part of the study was based on the following criteria:\n\n* Responders to Phase A treatment continued to receive the same double-blind treatment for an additional 8 weeks.\n* Non-responders Phase A treatment had their treatment assigned as follows:\n\n * Non-responders to OM 40 mg were treated with OM/HCTZ 40/12.5 mg for an additional 8 weeks.\n * Non-responders to OM/HCTZ 40/12.5 mg were uptitrated to OM/HCTZ 40/25 mg for an additional 8 weeks. During Phase B of the study, visits were held 12 and 16 weeks after randomisation (Visits 5 and 6, respectively).\n\nThe study ended at Visit 6 and a final examination was performed. A safety follow-up (SFU) telephone contact was performed 2 weeks after the end of the treatment. An SFU visit was performed if deemed necessary by the investigator.\n\nSphygmomanometer was used for BP measurement throughout the trial. BP was measured at all visits as nearly as possible at the same time of the day as trough readings (24 ± 2 h after last drug intake) after a 10 minute rest period. Three separate sitting BP measurements were taken at least 1 minute apart from each other. The 3 results were then averaged and rounded to a whole integer.\n\nPatients with sBP values \\> 200 mmHg and/or dBP values \\> 120 mmHg at any time during the study were to be discontinued from the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with a diagnosis of essential hypertension, either treatment-naive or including currently on anti-hypertensive medication (in Italy only treatment naive patients) in whom it is medically justifiable to withdraw treatment , and who are likely to meet the required BP inclusion criteria at randomisation:\n\n * Mean sitting dBP ≥ 100 mmHg and ≤ 120 mmHg.\n * Mean sitting sBP ≥ 160 mmHg and ≤ 200 mmHg.\n\nMain Exclusion Criteria:\n\n* Mean sitting sBP values \\> 200 mmHg and/or dBP \\> 120 mmHg.\n* Pregnant or nursing women.\n* Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the tested medication, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematological, oncological, neurological, and psychiatric diseases. The same applies for immunocompromised and/or neutropenic patients.\n* Patients with secondary hypertension of any aetiology such as renal disease, pheochromocytoma, or Cushing's syndrome."}, 'identificationModule': {'nctId': 'NCT00441350', 'briefTitle': 'Olmesartan/HCTZ 40/12.5 mg Combination Therapy Versus Olmesartan Medoxomil 40 mg Monotherapy in Essential Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Menarini Group'}, 'officialTitle': 'Phase III Study Evaluating the Efficacy and Safety of Olmesartan Medoxomil/Hydrochlorothiazide 40/12.5 mg Combination Therapy Versus Olmesartan Medoxomil 40 mg Monotherapy in Patients With Essential Hypertension', 'orgStudyIdInfo': {'id': 'CS866CM-B-E303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'OM 40', 'description': 'Olmesartanmedoxomil (OM)40 mg tablets.', 'interventionNames': ['Drug: OM 40']}, {'type': 'EXPERIMENTAL', 'label': 'OM/HCTZ 40/12.5', 'description': 'Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets.', 'interventionNames': ['Drug: OM/HCTZ 40/12.5']}], 'interventions': [{'name': 'OM 40', 'type': 'DRUG', 'otherNames': ['Treatment'], 'description': 'Initially patients were to be treated with Olmesartanmedoxomil (OM)40 mg tablets once daily for 8 weeks. After 8 weeks non-responders were to be uptitrated to OM/HCTZ 40/12.5 mg and responders remained on the previous therapy for further 8 weeks.', 'armGroupLabels': ['OM 40']}, {'name': 'OM/HCTZ 40/12.5', 'type': 'DRUG', 'otherNames': ['Treatment'], 'description': 'Initially patients were to be treated with Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets once daily for 8 weeks. After 8 weeks non-responders were to be uptitrated to OM/HCTZ 40/25 mg and responders remained on the previous therapy for further 8 weeks.', 'armGroupLabels': ['OM/HCTZ 40/12.5']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rijeka', 'country': 'Croatia', 'geoPoint': {'lat': 45.32673, 'lon': 14.44241}}, {'city': 'Slavonski Brod', 'country': 'Croatia', 'geoPoint': {'lat': 45.16158, 'lon': 18.0163}}, {'city': 'Split', 'country': 'Croatia', 'geoPoint': {'lat': 43.50891, 'lon': 16.43915}}, {'city': 'Varaždin', 'country': 'Croatia', 'geoPoint': {'lat': 46.30444, 'lon': 16.33778}}, {'city': 'Zadar', 'country': 'Croatia', 'geoPoint': {'lat': 44.11578, 'lon': 15.22514}}, {'city': 'Zagreb', 'country': 'Croatia', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'city': 'Benátky nad Jizerou', 'country': 'Czechia', 'geoPoint': {'lat': 50.29085, 'lon': 14.82343}}, {'city': 'Bílovec', 'country': 'Czechia', 'geoPoint': {'lat': 49.75639, 'lon': 18.01581}}, {'city': 'Brodce', 'country': 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