Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2026-01-02 @ 8:10 AM
Study NCT ID:
NCT00771069
Status:
COMPLETED
Last Update Posted:
2010-12-03
First Post:
2008-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypertensive Treatment Pattern Survey for Type II Diabetes Mellitus Patients With Complication and Hypertension
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-02', 'studyFirstSubmitDate': '2008-10-09', 'studyFirstSubmitQcDate': '2008-10-09', 'lastUpdatePostDateStruct': {'date': '2010-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Attainment rate to the target blood pressure.', 'timeFrame': 'After collecting all Patient Record Form.'}], 'secondaryOutcomes': [{'measure': 'Attainment to the target blood pressure will be investigated according to DM related complications.', 'timeFrame': 'After collecting all Patient Record Form.'}, {'measure': 'Change in the DBP/SBP value will be investigated according to the DM Complication', 'timeFrame': 'After collecting all Patient Record Form.'}, {'measure': 'Treatment pattern and factors that affect BP control', 'timeFrame': 'After collecting all Patient Record Form.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Type II DM', 'DM related complication', 'JNC7', '2007 ESH-ESC guidelines', 'survey'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'This study will address the treatment rate and control rate of hypertension, treatment pattern and factors to affect blood pressure control by examining (retrospective) medical records of Type II DM patients with DM related complication and hypertension, among outpatients coming to the Endocrinology Department in 20 general hospital settings nationwide.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Type II Diabetes Mellitus patients with Complication and Hypertension', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* After diagnosed type II DM, patients received treatment for a least 3 years\n* Type II DM patients with hypertension and its complication.\n* Visited out-patients to care center after 1 Jan. 2008\n\nExclusion Criteria:\n\n* Secondary hypertension patients\n* Patients not receiving hypertension medication\n* Patients stopping BP medication, by physician's order\n* Patients currently enrolled in other clinical studies"}, 'identificationModule': {'nctId': 'NCT00771069', 'acronym': 'CRYSTAL-CO', 'briefTitle': 'Hypertensive Treatment Pattern Survey for Type II Diabetes Mellitus Patients With Complication and Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Retrospective, Multi Centre, Non-interventional, Observational Study to Investigate Treatment Pattern of Blood Pressure in the Type II Diabetes Mellitus Patients With DM Related Complication and Hypertension.', 'orgStudyIdInfo': {'id': 'NIS-CKR-DUM-2008/3'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Type II Diabetes Mellitus patients with Complication and Hypertension'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wŏnju', 'state': 'Gangwon-do', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}, {'city': 'Bucheon-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'city': 'Guri-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.5986, 'lon': 127.1394}}, {'city': 'Sungnam', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Research Site'}, {'city': 'Suwon', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'city': 'Jeonju', 'state': 'Keollabuk', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Deagu', 'country': 'South Korea', 'facility': 'Research Site'}, {'city': 'Deajeon', 'country': 'South Korea', 'facility': 'Research Site'}, {'city': 'Incheon', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Kwangju', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 36.9122, 'lon': 127.1279}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Research Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Joonwoo Bahn', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astrazenca Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}}}}