Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-27 @ 8:13 AM
Study NCT ID:
NCT00803660
Status:
COMPLETED
Last Update Posted:
2009-07-09
First Post:
2008-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Survey on the Treatment of Hypertension in Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1060}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-08', 'studyFirstSubmitDate': '2008-12-03', 'studyFirstSubmitQcDate': '2008-12-04', 'lastUpdatePostDateStruct': {'date': '2009-07-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of patients achieving the BP<130/80 mmHg'}, {'measure': 'The percentage of patients achieving the BP<130/80 mmHg'}], 'secondaryOutcomes': [{'measure': 'The number and percentage of patients achieving the BP<130/80 mmHg by treatment groups'}, {'measure': 'The number and percentage of patients achieving HbA1c=<7%'}, {'measure': 'The number and percentage of patients achieving the FPG<110 mg%'}, {'measure': 'The association between unachievement of BP<130/80 mmHg and other factors (age, gender, CV risk factors, CV and diabetes history, duration of type of treatment...)'}, {'measure': 'The number and percentage of patients with positive proteinuria by treatment groups'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hypertension', 'BP', 'diabetes', 'anti-hypertensive treatment', 'ACE-I', 'ARB'], 'conditions': ['Hypertension', 'Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'Multi-centre survey of type 2 diabetic patients who are currently on anti-hypertensive treatment. Data collection for each patient will take place at one visit. To observe the proportion of diabetic patients on antihypertensive treatment reaching the BP\\<130/80 mmHg. To observe the proportion of diabetic patients on antihypertensive treatment reaching the BP\\<130/80 mmHg by treatment groups. To observe the proportion of patients achieving a therapeutic glycemic response defined as HbA1c=\\<7%. To observe the proportion of patients achieving fasting plasma glucose\\<110 mg%. To identify factors for not achieving BP\\<130/80 mmHg. To describe percentage of patients with positive proteinuria (including microalbuminuria) by treatment groups .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'type 2 diabetic patients who are currently using antihypertensive treatment for at least 3 months, with same regimen for a minimum of 4 weeks prior to the survey', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of written informed consent\n* Patient was diagnosed with type 2 diabetes\n* Patient is on antihypertensive treatments for at least 3 months, with the same regimen for a minimum of 4 weeks prior to survey\n\nExclusion Criteria:\n\n* Patients are critically ill, had mental health problems or difficulty in communication\n* Patients who are unwilling or unable to provide informed consent\n* Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site).'}, 'identificationModule': {'nctId': 'NCT00803660', 'briefTitle': 'Survey on the Treatment of Hypertension in Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'In Practice Survey on the Treatment of Hypertension in Patients With Type 2 Diabetes.', 'orgStudyIdInfo': {'id': 'NIS-CVN-DUM-2008/1'}}, 'contactsLocationsModule': {'locations': [{'city': 'Châu Đốc', 'state': 'An Giang', 'country': 'Vietnam', 'facility': 'Research Site', 'geoPoint': {'lat': 10.7, 'lon': 105.11667}}, {'city': 'Bạc Liêu', 'state': 'Bac Lieu', 'country': 'Vietnam', 'facility': 'Research Site', 'geoPoint': {'lat': 9.29414, 'lon': 105.72776}}, {'city': 'Qui Nhon', 'state': 'Binh Dinh', 'country': 'Vietnam', 'facility': 'Research Site', 'geoPoint': {'lat': 13.77648, 'lon': 109.22367}}, {'city': 'Cà Mau', 'state': 'Ca Mau', 'country': 'Vietnam', 'facility': 'Research Site', 'geoPoint': {'lat': 9.17682, 'lon': 105.15242}}, {'city': 'Can Tho', 'state': 'Can Tho City', 'country': 'Vietnam', 'facility': 'Research Site', 'geoPoint': {'lat': 10.03711, 'lon': 105.78825}}, {'city': 'Da Nang', 'state': 'Da Nang', 'country': 'Vietnam', 'facility': 'Research Site', 'geoPoint': {'lat': 16.06778, 'lon': 108.22083}}, {'city': 'Buon Me Thuoc', 'state': 'Dak Lak', 'country': 'Vietnam', 'facility': 'Research Site'}, {'city': 'Biên Hòa', 'state': 'Dong Nai', 'country': 'Vietnam', 'facility': 'Research Site', 'geoPoint': {'lat': 10.94469, 'lon': 106.82432}}, {'city': 'Thống Nhất', 'state': 'Dong Nai', 'country': 'Vietnam', 'facility': 'Research Site', 'geoPoint': {'lat': 10.95055, 'lon': 107.14571}}, {'city': 'Dong Thap', 'state': 'Dong Thap', 'country': 'Vietnam', 'facility': 'Research Site'}, {'city': 'Hanoi', 'state': 'Hanoi', 'country': 'Vietnam', 'facility': 'Research Site', 'geoPoint': {'lat': 21.0245, 'lon': 105.84117}}, {'city': 'Nha Trang', 'state': 'Khanh Hoa', 'country': 'Vietnam', 'facility': 'Research Site', 'geoPoint': {'lat': 12.24507, 'lon': 109.19432}}, {'city': 'Kiến Giang', 'state': 'Kien Giang', 'country': 'Vietnam', 'facility': 'Research Site', 'geoPoint': {'lat': 17.22328, 'lon': 106.79011}}, {'city': 'Nam Định', 'state': 'Nam Dinh', 'country': 'Vietnam', 'facility': 'Research Site', 'geoPoint': {'lat': 20.43389, 'lon': 106.17729}}, {'city': 'Thái Bình', 'state': 'Thai Binh', 'country': 'Vietnam', 'facility': 'Research Site', 'geoPoint': {'lat': 20.45, 'lon': 106.34002}}, {'city': 'Huế', 'state': 'Thua Thien', 'country': 'Vietnam', 'facility': 'Research Site', 'geoPoint': {'lat': 16.4619, 'lon': 107.59546}}, {'city': 'Tiền Giang', 'state': 'Tien Giang', 'country': 'Vietnam', 'facility': 'Research Site', 'geoPoint': {'lat': 18.33814, 'lon': 105.90892}}, {'city': 'Haiphong', 'country': 'Vietnam', 'facility': 'Research Site', 'geoPoint': {'lat': 20.86481, 'lon': 106.68345}}, {'city': 'Ho Chi Minh City', 'country': 'Vietnam', 'facility': 'Research Site', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}], 'overallOfficials': [{'name': 'Dang Van Phuoc, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Medicine and Pharmacy of HCMC'}, {'name': 'Pham Nguyen Vinh, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tam Duc Heart Hospital'}, {'name': 'Pham Gia Khai, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vietnam Heart Association'}, {'name': 'Nguyen Thy Khue, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Endocrinology and Diabetes Association of HCMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Vo Viet Tuan', 'oldOrganization': 'AstraZeneca Pharmaceuticals'}}}}