Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2025-12-26 @ 3:27 AM
Study NCT ID:
NCT01191450
Status:
COMPLETED
Last Update Posted:
2025-06-12
First Post:
2010-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Chlorthalidone + Amiloride to Elderly Patients Treatment With Arterial 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': 'D002752', 'term': 'Chlorthalidone'}, {'id': 'D000584', 'term': 'Amiloride'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D001577', 'term': 'Benzophenones'}, {'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D007094', 'term': 'Imides'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'fernanda.martinez@eurofarma.com.br', 'phone': '50 11 5090-8415', 'title': 'Eurofarma Laboratórios S.A', 'organization': 'Eurofarma Laboratórios S.A'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Higroton®', 'description': 'Chlorthalidone 25mg - one oral tablet a day in the morning\n\nHigroton® Laboratório Novartis: Chlortalidone 25mg - oral tablet a day in the morning during approximately 12 weeks', 'otherNumAtRisk': 121, 'otherNumAffected': 41, 'seriousNumAtRisk': 121, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Diupress®', 'description': 'Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning\n\nChlorthalidone 25 mg + amiloride hydrochloride 5 mg: Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning during approximately 12 weeks', 'otherNumAtRisk': 122, 'otherNumAffected': 55, 'seriousNumAtRisk': 122, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Musculoskeletal and Connective Tissue Disorders', 'notes': 'Arthralgia Pain in extremity Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'General Disorders and Administration Site Conditions', 'notes': 'Asthenia (weakness) Feeling abnormal Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolism and Nutrition Disorders', 'notes': 'Hypercholesterolemia Hyperglycaemia Hyperkalaemia Hypertriglyceridaemia Hyperuricaemia Hypokalaemia Glycosylated haemoglobin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 31, 'numAffected': 31}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Investigations', 'notes': 'Blood creatine increased Blood uric acid increased Electrocardiogram abnormal Leukopenia Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nervous System Disorders', 'notes': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal and Urinary Disorders', 'notes': 'Pollakiuria Polyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Reproductive System and Breast Disorders', 'notes': 'Erectile dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Immune System Disorders', 'notes': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular Disorders', 'notes': 'Hypertension Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal Disorders', 'notes': 'Nausea Vomiting NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Myocardial ischaemia', 'notes': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Myocardial ischaemia'}, {'term': 'Abdominal pain NOS', 'notes': 'Abdominal pain NOS, Hyperthermia, Vomiting NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Innappetence', 'notes': 'NAUSEA, VOMITING, LACK OF APPETENCE AFTER STRONG EMOTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 122, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Diupress®', 'description': 'Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning\n\nChlorthalidone 25 mg + amiloride hydrochloride 5 mg: Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning during approximately 12 weeks'}, {'id': 'OG001', 'title': 'Higroton®', 'description': 'Chlorthalidone 25mg - one oral tablet a day in the morning\n\nHigroton® Laboratório Novartis: Chlortalidone 25mg - oral tablet a day in the morning during approximately 12 weeks'}], 'classes': [{'title': 'V1 (15 ± 3 days after V0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'V2 (30 ± 3 days after V0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'V3 (60 ± 3 days after V0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'V4 (90 ± 3 days after V0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 4 (75 ± 3 days of V1)', 'description': 'V0 (baseline) V1 (15 ± 3 days after V0) V2 (30 ± 3 days after V0) V3 (60 ± 3 days after V0) V4 (90 ± 3 days after V0)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis of ITT. The number of participants differed across visits due to variations in attendance.'}, {'type': 'SECONDARY', 'title': 'Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Diupress®', 'description': 'Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning\n\nChlorthalidone 25 mg + amiloride hydrochloride 5 mg: Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning during approximately 12 weeks'}, {'id': 'OG001', 'title': 'Higroton®', 'description': 'Chlorthalidone 25mg - one oral tablet a day in the morning\n\nHigroton® Laboratório Novartis: Chlortalidone 25mg - oral tablet a day in the morning during approximately 12 weeks'}], 'classes': [{'title': 'V1 delta systolic blood pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '130.52', 'spread': '15.70', 'groupId': 'OG000'}, {'value': '131.06', 'spread': '13.07', 'groupId': 'OG001'}]}]}, {'title': 'V4 delta systolic blood pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '120.64', 'spread': '11.73', 'groupId': 'OG000'}, {'value': '124.05', 'spread': '13.09', 'groupId': 'OG001'}]}]}, {'title': 'V1 Delta diastolic blood pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.63', 'spread': '10.46', 'groupId': 'OG000'}, {'value': '79.08', 'spread': '9.50', 'groupId': 'OG001'}]}]}, {'title': 'V4 delta diastolic blood pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.63', 'spread': '8.73', 'groupId': 'OG000'}, {'value': '75.24', 'spread': '9.68', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Visit 4 (75 ± 3 days of V1)', 'description': 'Will be considered as secondary outcomes BP \\<140 X 90 mmHg after Visit 4 (75 ± 3 days of V1).\n\nV0 (baseline) V1 (15 ± 3 days after V0) V2 (30 ± 3 days after V0) V3 (60 ± 3 days after V0) V4 (90 ± 3 days after V0)', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. The number of participants differed across visits due to variations in attendance.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Higroton®', 'description': 'Chlorthalidone 25mg - one oral tablet a day in the morning\n\nHigroton® Laboratório Novartis: Chlortalidone 25mg - oral tablet a day in the morning during approximately 12 weeks'}, {'id': 'FG001', 'title': 'Diupress®', 'description': 'Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning\n\nChlorthalidone 25 mg + amiloride hydrochloride 5 mg: Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning during approximately 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}, {'groupId': 'FG001', 'numSubjects': '122'}]}, {'type': 'ITT Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}, {'groupId': 'FG001', 'numSubjects': '122'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}, {'groupId': 'FG001', 'numSubjects': '104'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '18'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '243', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Higroton®', 'description': 'Chlorthalidone 25mg - one oral tablet a day in the morning\n\nHigroton® Laboratório Novartis: Chlortalidone 25mg - oral tablet a day in the morning during approximately 12 weeks'}, {'id': 'BG001', 'title': 'Diupress®', 'description': 'Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning\n\nChlorthalidone 25 mg + amiloride hydrochloride 5 mg: Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning during approximately 12 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'spread': '7', 'groupId': 'BG000'}, {'value': '61', 'spread': '8', 'groupId': 'BG001'}, {'value': '62', 'spread': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'ITT population'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 246}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-26', 'studyFirstSubmitDate': '2010-08-26', 'resultsFirstSubmitDate': '2019-10-08', 'studyFirstSubmitQcDate': '2010-08-27', 'lastUpdatePostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-26', 'studyFirstPostDateStruct': {'date': '2010-08-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Serum Potassium Levels Below 4.0 mEq/l at Visit 4', 'timeFrame': 'Visit 4 (75 ± 3 days of V1)', 'description': 'V0 (baseline) V1 (15 ± 3 days after V0) V2 (30 ± 3 days after V0) V3 (60 ± 3 days after V0) V4 (90 ± 3 days after V0)'}], 'secondaryOutcomes': [{'measure': 'Blood Pressure', 'timeFrame': 'Visit 4 (75 ± 3 days of V1)', 'description': 'Will be considered as secondary outcomes BP \\<140 X 90 mmHg after Visit 4 (75 ± 3 days of V1).\n\nV0 (baseline) V1 (15 ± 3 days after V0) V2 (30 ± 3 days after V0) V3 (60 ± 3 days after V0) V4 (90 ± 3 days after V0)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chlortalidone', 'amiloride', 'arterial hypertension'], 'conditions': ['Arterial Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy and safety of Chlorthalidone 25 mg + amiloride hydrochloride 5 mg association in the treatment of elderly patients with arterial hypertension.', 'detailedDescription': 'To assess the efficacy and safety of the association of Chlorthalidone 25 mg + amiloride hydrochloride 5 mg (Diupress® Eurofarma) in the treatment of elderly patients with arterial hypertension, compared to Chlorthalidone 25mg (Higroton® Laboratório Novartis) in same presentation form.\n\nSome eligibility criteria:\n\nperform blood and urine tests; ECG (electrocardiogram); ABPM (Ambulatory Blood Pressure Monitoring; Echocardiogram;Doppler Echocardiogram'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Systolic blood pressure between 140 mmHg - 159 mmHg\n* Diastolic blood pressure between 90 mmHg - 99 mmHg\n* Subject aged ≥ 60 years old\n* Be able to comply with instructions, attend study follow-up visits and be willing to participate in the research project.\n* Diagnosis of stage 1 arterial hypertension with no prior treatment more than 120 days or uncontrolled during antihypertensive agent administration.\n\nExclusion Criteria:\n\n* Any serious or severe clinically significant medical condition.\n* Psychiatric or neurological diseases\n* A condition that, as per Principal Investigator's opinion, may interfere with the optimal participation in the study, or that may result in special risk to the patient.\n* Participation in any other investigational study within 12 months prior to Visit 1.\n* Known medical history of allergy, hypersensitivity or intolerance to any of the formulation compounds to be used in this study\n* Routine prior use of diuretics\n* Oral anticoagulant use\n* Fast glycemia \\> 150 mg/dL\n* Medical treatment, not related to study, scheduled for the clinical trial duration; except non-serious, controlled comorbidities in current medical follow-up.\n* Expected onset of additional antihypertensive drug after the study onset\n* Acute myocardial infarction within last 6 months\n* Prior decompensated coronary artery disease\n* Known thyroid, renal or liver dysfunction, at investigator's discretion\n* Obesity - body mass index (BMI) \\> 33 kg/m2"}, 'identificationModule': {'nctId': 'NCT01191450', 'acronym': 'CARD', 'briefTitle': 'Safety and Efficacy of Chlorthalidone + Amiloride to Elderly Patients Treatment With Arterial Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eurofarma Laboratorios S.A.'}, 'officialTitle': 'A Study to Evaluate the Safety and Efficacy of Chlorthalidone in Combination With Amiloride as a Treatment for Elderly Patients With Arterial Hypertension', 'orgStudyIdInfo': {'id': 'EF 114'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Higroton®', 'description': 'Chlorthalidone 25mg - one oral tablet a day in the morning', 'interventionNames': ['Drug: Higroton® Laboratório Novartis']}, {'type': 'EXPERIMENTAL', 'label': 'Diupress®', 'description': 'Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning', 'interventionNames': ['Drug: Chlorthalidone 25 mg + amiloride hydrochloride 5 mg']}], 'interventions': [{'name': 'Chlorthalidone 25 mg + amiloride hydrochloride 5 mg', 'type': 'DRUG', 'otherNames': ['Diupress® (Eurofarma Laboratórios Ltda.)'], 'description': 'Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning during approximately 12 weeks', 'armGroupLabels': ['Diupress®']}, {'name': 'Higroton® Laboratório Novartis', 'type': 'DRUG', 'description': 'Chlortalidone 25mg - oral tablet a day in the morning during approximately 12 weeks', 'armGroupLabels': ['Higroton®']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fortaleza', 'state': 'Ceará', 'country': 'Brazil', 'facility': 'Centro de Estudos de Diabetes e Hipertensão', 'geoPoint': {'lat': -3.71722, 'lon': -38.54306}}, {'city': 'Vitória', 'state': 'Espírito Santo', 'country': 'Brazil', 'facility': 'CEDOES - Centro de Diagnóstico e Pesquisa de Osteoporose do Espírito Santo', 'geoPoint': {'lat': -20.31944, 'lon': -40.33778}}, {'city': 'Goiânia', 'state': 'Goiás', 'country': 'Brazil', 'facility': 'Liga de Hipertensão Arterial - Universidade Federal de Goiás', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}, {'city': 'Botucatu', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina - UNESP', 'geoPoint': {'lat': -22.88583, 'lon': -48.445}}, {'city': 'São José do Rio Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Centro de Pesquisa Clínica do IMC - Instituto de Moléstias Cardiovasculares', 'geoPoint': {'lat': -20.81972, 'lon': -49.37944}}, {'city': 'Tatuí', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto de Moléstias Cardiovasculares de Tatuí', 'geoPoint': {'lat': -23.35556, 'lon': -47.85694}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Clínica Paulista de Doenças Cardiovasculares - FGM', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Santa Marcelina', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital São Camilo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'IMA - Instituto de Medicina Avançada', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Paulo Guilherme O Silva', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Santa Marcelina'}, {'name': 'Humberto Freitas', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital São Camilo'}, {'name': 'Jose Carlos A Ayob', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro de Pesquisas Clínicas do Instituto de Moléstias Cardiovasculares'}, {'name': 'Roberto Jorge S Franco', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unidade de Pesquisa Clínica (UPECLIN)- Hospital das Clínicas UNESP'}, {'name': 'Fernando Augusto A Costa', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'FGM - Clínica Paulista de Doenças Cardiovasculares'}, {'name': 'Adriana C Forti', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro de Estudos de Diabetes e Hipertensão'}, {'name': 'Paulo Cesar V Jardim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Liga de Hipertensão Arterial - Universidade Federal de Goiás'}, {'name': 'Marise L Castro', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IMA - Instituto de Medicina Avançada'}, {'name': 'Daniela G Barbieri', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CEDOES - Centro de Diagnóstico e Pesquisa de Osteoporose do Espírito Santo'}, {'name': 'Fábio José C Fucci', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto de Moléstias Cardiovasculares de Tatuí'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eurofarma Laboratorios S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}