Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-02-28 @ 2:28 PM
Study NCT ID:
NCT01766505
Status:
TERMINATED
Last Update Posted:
2014-03-14
First Post:
2013-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Study to Evaluate Efficacy and Safety of Candesartan vs Losartan in Hypertension With Heart Failure (HONOR)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'whyStopped': 'lack of the subjects', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-12', 'studyFirstSubmitDate': '2013-01-10', 'studyFirstSubmitQcDate': '2013-01-10', 'lastUpdatePostDateStruct': {'date': '2014-03-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'rate of adverse event', 'timeFrame': 'up to 16 weeks'}, {'measure': 'medication history', 'timeFrame': 'up to 16 weeks'}], 'primaryOutcomes': [{'measure': 'change from baseline average sitting DBP(diastolic blood pressure)at 16 weeks', 'timeFrame': 'baseline, 16 weeks'}], 'secondaryOutcomes': [{'measure': 'change from baseline average sitting DBP(diastolic blood pressure)at 8 weeks', 'timeFrame': 'baseline, 8 weeks'}, {'measure': 'change from baseline average sitting SBP(systolic blood pressure)at 8 weeks', 'timeFrame': 'baseline, 8 weeks'}, {'measure': 'change from baseline average sitting SBP(systolic blood pressure)at 16 weeks', 'timeFrame': 'baseline, 16 weeks'}, {'measure': 'ratio of normalize from baseline blood pressure at 16 weeks', 'timeFrame': 'baseline, 16 weeks', 'description': 'normalize means that sitting SBP and DBP is below 140mmHg and 90mmHg'}, {'measure': 'response ratio from baseline blood pressure at 16 weeks', 'timeFrame': 'baseline, 16 weeks', 'description': 'response means that decrease in sitting DBP and SBP is above 10mmHg and 20mmHg'}, {'measure': 'change from baseline LVEF(left ventricular ejection fraction at 16 weeks', 'timeFrame': 'baseline, 16 weeks'}, {'measure': 'change from baseline LVEDD(left ventricular end-diastolic diameter)at 16 weeks', 'timeFrame': 'baseline, 16 weeks'}, {'measure': 'change from baseline LV(left ventricular) mass at 16 weeks', 'timeFrame': 'baseline, 16 weeks'}, {'measure': 'change from baseline PWV(pulse wave velocity) mass at 16 weeks', 'timeFrame': 'baseline, 16 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hypertension, heart failure, candesartan, losartan'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare efficacy and safety of candesartan and losartan in hypertension with heart failure.', 'detailedDescription': 'This is a randomized, open-label, phase 4 study. wash out periods need at least 14 days if the patients take ARB or ACE inhibitor to control Blood pressure. Patients take Candemore or Cozzar once a day during 16 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female and male patients who aged above 19 and below 75\n* Patients with 90\\~109mmHg average sitting DBP on baseline\n* NYHA class 2\\~4\n* Patients who agreement with written informed consent\n\nExclusion Criteria:\n\n* above 110mmHg sitting DBP and/or 180mmHg sitting SBP\n* Patients who have difference values that above 20mmHg sitting SBP or 10mmHg sitting DBP in both arms on screening\n* Patients who have medical history that secondary hypertension or rule out secondary hypertension\n* malignant hypertension\n* symptomatic postural hypotension\n* right heart failure due to pulmonary disease\n* etc.'}, 'identificationModule': {'nctId': 'NCT01766505', 'briefTitle': 'The Study to Evaluate Efficacy and Safety of Candesartan vs Losartan in Hypertension With Heart Failure (HONOR)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'Randomized, Open-label, Phase 4 Study to Evaluate Efficacy and Safety of Candesartan and Losartan in the Patients With Hypertension and Heart Failure.', 'orgStudyIdInfo': {'id': 'm111HHF11F'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Candemore tablet', 'description': 'Candemore tablet: candesartan cilexetil 8mg, 16mg, 32mg/tab, orally, 1 tablet once a day during 16 weeks', 'interventionNames': ['Drug: Candemore tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cozzar tablet', 'description': 'Cozzar tablet: Losartan potassium 50mg, 100mg/cap, orally, 1 capsule once a day during 16 weeks', 'interventionNames': ['Drug: Cozzar tablet']}], 'interventions': [{'name': 'Candemore tablet', 'type': 'DRUG', 'description': 'Candemore tablet 8, 16, or 32mg/tab, per oral, a tablet once a day during 16 weeks.\n\ndosage is depends on the sitting blood pressure.', 'armGroupLabels': ['Candemore tablet']}, {'name': 'Cozzar tablet', 'type': 'DRUG', 'description': 'Cozzar tablet: 8mg, 16mg, 32mg/tablet, per oral, a tablet a day during 16 weeks dosage depends on sitting blood pressure', 'armGroupLabels': ['Cozzar tablet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '301-721', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Chungnam national university hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '301-723', 'city': 'Daejeon', 'country': 'South Korea', 'facility': "The catholic university of Korea, Daejeon st. Mary's Hospital", 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '302-718', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Konyang university hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '302-799', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Eulji University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '501-757', 'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Chunnam National University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '503-715', 'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Kwangju Christian Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '560-750', 'city': 'Jeonju', 'country': 'South Korea', 'facility': 'Presbyterian Medical Center', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'zip': '561-712', 'city': 'Jeonju', 'country': 'South Korea', 'facility': 'Chunbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'zip': '540-719', 'city': 'Suncheon', 'country': 'South Korea', 'facility': 'ST.Carollo hospital', 'geoPoint': {'lat': 34.9505, 'lon': 127.48784}}], 'overallOfficials': [{'name': 'Myungho Jeong, phD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chonnam National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}