Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-26 @ 12:23 AM
Study NCT ID:
NCT00394394
Status:
COMPLETED
Last Update Posted:
2006-11-01
First Post:
2006-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antihypertensive Effectiveness of the Associations of Hydrochlorothiazide and Amiloride and Hydrochlorothiazide and Enalapril
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-10', 'lastUpdateSubmitDate': '2006-10-30', 'studyFirstSubmitDate': '2006-10-30', 'studyFirstSubmitQcDate': '2006-10-30', 'lastUpdatePostDateStruct': {'date': '2006-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean blood pressure measured with 24-hour ambulatory blood pressure monitoring after 12 weeks of follow-up'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients who needed to double the dose of enalapril or amiloride in forth or eighth week or use propranolol in the eighth week follow-up visiting.'}, {'measure': 'Fasting blood glucose differences between the baseline and twelve-week follow-up visiting.'}, {'measure': 'Serum potassium differences between the baseline and twelve-week follow-up visiting.'}, {'measure': 'Serum total cholesterol, LDL- cholesterol, HDL- cholesterol and triglycerides differences between the baseline and twelve-week follow-up visiting.'}, {'measure': 'Serum uric acid differences between the baseline and twelve-week follow-up visiting.'}, {'measure': 'Urine microalbuminuria differences between the baseline and twelve-week follow-up visiting.'}]}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '18855259', 'type': 'DERIVED', 'citation': 'Guerrero P, Fuchs FD, Moreira LM, Martins VM, Bertoluci C, Fuchs SC, Gus M. Blood pressure-lowering efficacy of amiloride versus enalapril as add-on drugs in patients with uncontrolled blood pressure receiving hydrochlorothiazide. Clin Exp Hypertens. 2008 Oct;30(7):553-64. doi: 10.1080/10641960802441906.'}]}, 'descriptionModule': {'briefSummary': "The majority of hypertensive patients require antihypertensive associations to control their blood pressure. Most of clinical trials don't compare different associations using Hydrochlorothiazide 25 mg as the standard initial therapy and compare the associations using doses that are not equivalent.\n\nThis randomized trial where patients and investigators are blinded and compares the effectiveness two associations: Hydrochlorothiazide and Amiloride and Hydrochlorothiazide and Enalapril."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who are using Hydrochlorothiazide 25mg/d at least in a four weeks treatment and had their office blood pressure not controlled (systolic or diastolic greater than 140 mmHg or 90 mmHg, respectively).\n\nExclusion Criteria:\n\n* Established cardiovascular disease\n* Diabetics in use of insulin\n* Impairment renal in renal function\n* Contraindications for the study medications'}, 'identificationModule': {'nctId': 'NCT00394394', 'briefTitle': 'Antihypertensive Effectiveness of the Associations of Hydrochlorothiazide and Amiloride and Hydrochlorothiazide and Enalapril', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Clinicas de Porto Alegre'}, 'officialTitle': 'Hydrochlorothiazide and Amiloride vs Hydrochlorothiazide and Enalapril: a Randomized Clinical Trial of Antihypertensive Effectiveness.', 'orgStudyIdInfo': {'id': '04002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Amiloride 2,5/d or Enalapril/d 10 mg', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90035-903', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital de Clínicas de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'overallOfficials': [{'name': 'Miguel Gus', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de Clínicas de Porto Alegre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Clinicas de Porto Alegre', 'class': 'OTHER'}}}}