Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-04-03 @ 5:28 PM
Study NCT ID:
NCT01907958
Status:
UNKNOWN
Last Update Posted:
2013-07-25
First Post:
2013-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management of Albuminuria in Hypertensive Diabetics
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'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'urine whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 280}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-07-24', 'studyFirstSubmitDate': '2013-07-18', 'studyFirstSubmitQcDate': '2013-07-24', 'lastUpdatePostDateStruct': {'date': '2013-07-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Demographics, medical history and medication Diabetes and hypertension status Blood pressure measurements', 'timeFrame': '12 months'}], 'primaryOutcomes': [{'measure': 'Stabilisation or improvement of urine albumin excretion status by at least one stage', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Microalbuminuria (or further stages of CKD) after 12 months', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Microalbuminuria', 'Hypertensive', 'Diabetics', 'urine albumin'], 'conditions': ['Microalbuminuria', 'Hypertension', 'Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'Multicenter stepped wedge cluster randomized trial of family practice clinics in Quebec and Ontario comparing the effect of introducing a Point of Care testing (POCT) for urine albumin to usual practice on quality of care in hypertensive patients with Type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '18 years and older Uncontrolled blood pressure Type 2 diabetes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female 18 years and older and able to visit the study sites every 3 months\n* T2D patients with ongoing anti-diabetic therapy for at least 5 years\n* Uncontrolled hypertension according to 2012 CHEP recommendations for management of hypertension in diabetic patients ( i.e. BP\\> 130/80 mmHg)\n* Able and agreeing to provide informed consent.\n\nExclusion Criteria:\n\n* Type 1 diabetes patients\n* Ongoing therapy with perindopril,\n* Known hypersensitivity or allergies to ACEI or sulfonamide derivatives,\n* A history of angioedema related or not to previous treatment with ACEI,\n* Impaired renal function defined as serum creatinine levels \\> 177 µmol/L, eGFR \\<30 mL/min,\n* Hyperkalemia or hypokalemia,\n* Severe hepatic impairment,\n* Use of non-antiarrhythmic agents causing torsade de pointes,\n* Pregnant or lactating women, or who are planning to become pregnant,\n* Any conditions which may impact on participation according to treating physician.'}, 'identificationModule': {'nctId': 'NCT01907958', 'acronym': 'CLINPRADIA', 'briefTitle': 'Management of Albuminuria in Hypertensive Diabetics', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medpharmgene, Inc.'}, 'officialTitle': 'A Multicentre Study to Evaluate the Management of Microalbuminuria in Hypertensive Patients With Type 2 Diabetes: Improving Clinical Practice', 'orgStudyIdInfo': {'id': 'CLINPRADIA'}}, 'contactsLocationsModule': {'locations': [{'zip': 'H1Y 3L1', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Marie-Renée Guertin, Project manager', 'role': 'CONTACT', 'email': 'm-r.guertin@medpharmgene.ca', 'phone': '514 249 4209', 'phoneExt': '222'}, {'name': 'Pavel Hamet', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medpharmgene', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Marie-Renée GUERTIN, project manager', 'role': 'CONTACT', 'email': 'm-r.guertin@medpharmgene.ca', 'phone': '514 249 4209', 'phoneExt': '222'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medpharmgene, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}