Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2025-12-26 @ 1:30 AM
Study NCT ID:
NCT00607633
Status:
COMPLETED
Last Update Posted:
2008-02-06
First Post:
2008-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Candesartan and Candesartan/ Hydrochlorothiazide in the Treatment of Patients With Hypertension and LVH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075222', 'term': 'Essential Hypertension'}, {'id': 'D017379', 'term': 'Hypertrophy, Left Ventricular'}], 'ancestors': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006332', 'term': 'Cardiomegaly'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D006984', 'term': 'Hypertrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 686}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-02-05', 'studyFirstSubmitDate': '2008-01-23', 'studyFirstSubmitQcDate': '2008-02-05', 'lastUpdatePostDateStruct': {'date': '2008-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to estimate under naturalistic conditions the impact of the antihypertensive therapy with candesartan or candesartan/HCT on pre-post change from Visit 1 to Visit 2 of Sokolow-Lyon index, Cornell index and Left Ventricular Mass Index.', 'timeFrame': 'app. 3 monthly'}], 'secondaryOutcomes': [{'measure': 'to estimate the change of the systolic and diastolic blood pressure, separately by the (maximum) prescribed daily dose of candesartan or candesartan/ HCT', 'timeFrame': 'app. 3 monthly'}, {'measure': 'to gain further insight into the occurrence of unknown, unexpected and/or rarely occurring adverse events (AE) by estimating the incidence under naturalistic conditions.', 'timeFrame': 'app. 3 monthly'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['essential hypertension', 'ARB', 'left ventricular hypertrophy', 'candesartan'], 'conditions': ['Essential Hypertension', 'Left Ventricular Hypertrophy']}, 'descriptionModule': {'briefSummary': 'The CandLE study with at maximum daily dose of 32 mg candesartan or 16/12.5 mg candesartan/hydrochlorothiazide has the objective to evaluate under naturalistic conditions, i.e. under routine medical care conditions, the impact of the antihypertensive therapy with candesartan or candesartan/HCT on relevant medical parameters related to the left ventricular hypertrophy (LVH) as well as the efficacy and tolerability of candesartan or candesartan/HCT in subjects suffering from essential hypertension..'}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Ambulant patient', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* essential hypertension\n* left ventricular hypertrophy\n* under candesartan treatment\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT00607633', 'acronym': 'CandLE', 'briefTitle': 'Candesartan and Candesartan/ Hydrochlorothiazide in the Treatment of Patients With Hypertension and LVH', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Candesartan and Candesartan/ Hydrochlorothiazide in the Treatment of Patients With Essential Hypertension and a Concomitant Disease Left Ventricular Hypertrophy', 'orgStudyIdInfo': {'id': 'NIS-CGE-ATA-2007/2'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patient with essential hypertension and LVH under treatment with candesartan or candesartan HCT'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'F. Sonntag, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiologist, Henstedt-Ulzburg'}, {'name': 'Andrea Pahor, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'MED Dep., AstraZeneca Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Andrea Pahor', 'oldOrganization': 'AstraZeneca Germany'}}}}