Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2026-01-01 @ 8:16 PM
Study NCT ID:
NCT00796159
Status:
COMPLETED
Last Update Posted:
2009-12-23
First Post:
2008-11-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Marketing Surveillance Of Olmesartan Medoxomil In Combination With Hydrochlorothiazide
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D000075222', 'term': 'Essential Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068557', 'term': 'Olmesartan Medoxomil'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1723}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-21', 'studyFirstSubmitDate': '2008-11-20', 'studyFirstSubmitQcDate': '2008-11-21', 'lastUpdatePostDateStruct': {'date': '2009-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety (Adverse Events)', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Blood Pressure', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Efficacy; Tolerability; Safety; Essential Hypertension'], 'conditions': ['Hypertension']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0021004&StudyName=Post-Marketing%20Surveillance%20Of%20Olmesartan%20Medoxomil%20In%20Combination%20With%20Hydrochlorothiazide%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This is a Post-Marketing Surveillance study evaluating the Efficacy, Tolerability and Safety of Olmesartan medoxomil 20 mg in combination with 12.5 MG of hydrochlorothiazide in subjects with mild to moderate essential hypertension', 'detailedDescription': 'Non Probability Sampling'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Filipino patients with Uncontrolled Mild to Moderate Essential Hypertension', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and Female patients 18 to 65 y/old\n* Patient previously taking low-dose medoxomil or any other ARB alone with uncontrolled BP\n* Patient with uncontrolled mild to moderate hypertension (SBP\\>= 140 and \\<=179 mmHg OR DBP of \\>=90 and \\<=109 mmHg)\n\nExclusion Criteria:\n\n* Pregnant of Lactating women\n* History of secondary hypertension'}, 'identificationModule': {'nctId': 'NCT00796159', 'briefTitle': 'Post-Marketing Surveillance Of Olmesartan Medoxomil In Combination With Hydrochlorothiazide', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Post Marketing Surveillance, Multicenter, Open-Label, Dose-Titrating, 4-Week Study Evaluating The Efficacy, Tolerability And Safety Of Olmesartan Medoxomil 20mg In Combination With 12.5mg Hydrochlorothiazide In Subjects With Stage 1 To Stage 2 Hypertension', 'orgStudyIdInfo': {'id': 'A0021004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Olmesartan medoxomil + HCTZ', 'interventionNames': ['Drug: Olmesartan medoxomil']}], 'interventions': [{'name': 'Olmesartan medoxomil', 'type': 'DRUG', 'description': 'olmesartan medoxomil 20 mg and HCTZ 12.5 mg', 'armGroupLabels': ['Olmesartan medoxomil + HCTZ']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}