Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-27 @ 11:59 PM
Study NCT ID:
NCT01393860
Status:
COMPLETED
Last Update Posted:
2011-07-14
First Post:
2011-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-world Aliskiren Use in Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'lastUpdateSubmitDate': '2011-07-13', 'studyFirstSubmitDate': '2011-07-11', 'studyFirstSubmitQcDate': '2011-07-12', 'lastUpdatePostDateStruct': {'date': '2011-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure: Change in blood pressure', 'timeFrame': 'baseline and 1 year'}], 'secondaryOutcomes': [{'measure': 'Measure: Change in urine microalbumin', 'timeFrame': 'baseline and 1 year'}, {'measure': 'Measure: Change in creatinine', 'timeFrame': 'baseline and 1 year'}, {'measure': 'Measure: Change in potassium levels', 'timeFrame': 'baseline and 1 year'}]}, 'conditionsModule': {'keywords': ['Diabetes', 'aliskiren', 'hypertension', 'renal impairment'], 'conditions': ['Diabetes', 'Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate real-world patterns of aliskiren use with a focus of change in renal function following aliskiren initiation as well as to identify "triggering events" that lead to aliskiren initiation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Diabetic patients with hypertension who were initiated on aliskiren', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes\n* Patients ages 18 yeras and older\n* Hypertension Diagnosis\n* Currently on at least 1 hypertensive medication\n* At least 2 lab measure before and after aliskiren initiation\n\nExclusion Criteria:\n\n* Inadequate chart records where microalbuminuria, serum creatinine and blood pressure data are not within 3-12 months prior to initiation of Aliskiren\n* Pregnancy\n* Development of secondary renal disease unrelated to diabetes (such as nephritis)\n* Terminal illness\n* AIDS/HIV Other protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01393860', 'briefTitle': 'Real-world Aliskiren Use in Diabetic Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': "Aliskiren Use in Diabetic Patients: Who's Using it, Why, and How is it Working ?", 'orgStudyIdInfo': {'id': 'HEORUS0081'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Aliskiren', 'description': 'Diabetic nephropathy'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'MD 21204', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'MODEL Clinical Research, Research Division of Bay Endocrinology Associates GBMC Physicians pavilion North', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Phamaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Clinical Disclosure Office', 'oldOrganization': 'Novartis Pharmaceuticals'}}}}