Ignite Creation Date:
2025-12-24 @ 6:34 PM
Ignite Modification Date:
2025-12-28 @ 9:38 PM
Study NCT ID:
NCT01260857
Status:
WITHDRAWN
Last Update Posted:
2013-05-14
First Post:
2010-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety And Efficacy Of Spirinolactone Plus Hydroflumethiazide In The Treatment Of Filipino Patients With Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D011507', 'term': 'Proteinuria'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006857', 'term': 'Hydroflumethiazide'}], 'ancestors': [{'id': 'D001581', 'term': 'Benzothiadiazines'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D049971', 'term': 'Thiazides'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2015-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-05-13', 'studyFirstSubmitDate': '2010-12-14', 'studyFirstSubmitQcDate': '2010-12-14', 'lastUpdatePostDateStruct': {'date': '2013-05-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Report of Adverse Events occurence (Safety)', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Systolic BP in mmHg', 'timeFrame': '8 weeks'}, {'measure': 'Diastolic BP in mmHg', 'timeFrame': '8 weeks'}, {'measure': '% of patients reaching BP goal of <140/90 mmHg and <130/80 mmHg for DM and proteinuric patients', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Spirinolactone', 'Hydroflumethiazide', 'Hypertension', 'Filipinos', 'Diabetes mellitus', 'Proteinuria'], 'conditions': ['Hypertension']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6821003&StudyName=Safety%20And%20Efficacy%20Of%20Spirinolactone%20Plus%20Hydroflumethiazide%20In%20The%20Treatment%20Of%20Filipino%20Patients%20With%20Hypertension', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Aldazide 25 mg OD will be given to Filipino hypertensive patients, and there will be 2 follow-up visits on week 4 and week 8 to monitor for safety and efficacy as primary and secondary outcomes, respectively.', 'detailedDescription': 'Prospective, non-interventional non-probability sampling'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients ages \\>/= 18 years old with Stage 1 or 2 hypertension', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\>/= 18 years old with Stage 1 or 2 hypertension not controlled by monotherapy or by a combination of anti-hypertensives without any diuretic yet.\n\nExclusion Criteria:\n\n* Pregnant or lactating women, with hypersensitivity to Aldazide, patients with resistant hypertension not controlled by a combination therapy with a diuretic in their regimen'}, 'identificationModule': {'nctId': 'NCT01260857', 'briefTitle': 'Safety And Efficacy Of Spirinolactone Plus Hydroflumethiazide In The Treatment Of Filipino Patients With Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'An Open Label, Observational, Post Marketing Surveillance Study To Assess The Safety And Efficacy Of The Spironolactone Plus Hydroflumethiazide (Aldazide) In The Treatment Of Filipino Patients With Stage 1 To 2 Hypertension', 'orgStudyIdInfo': {'id': 'A6821003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Aldazide', 'type': 'DRUG', 'otherNames': ['Spirinolactone + Hydroflumethiazide'], 'description': 'Aldazide 25 mg OD'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}