Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-27 @ 10:08 PM
Study NCT ID:
NCT01038895
Status:
UNKNOWN
Last Update Posted:
2009-12-24
First Post:
2009-12-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aliskiren Versus Ramipril on Antiproteinuric Effect in Hypertensive, Type 2 Diabetic Patients With Microalbuminuria
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017257', 'term': 'Ramipril'}], 'ancestors': [{'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-12-23', 'studyFirstSubmitDate': '2009-12-23', 'studyFirstSubmitQcDate': '2009-12-23', 'lastUpdatePostDateStruct': {'date': '2009-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antiproteinuric effect as well as antihypertensive effect of aliskiren 300 mg / daily versus ramipril 10 mg daily in hypertensive patients with type 2 diabetes and microalbuminuria.', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Average of 24 hours by ABPM, systolic and diastolic blood pressure', 'timeFrame': '3 months'}, {'measure': 'Average daytime, systolic and diastolic blood pressure', 'timeFrame': '3 months'}, {'measure': 'Average night, systolic and diastolic blood pressure', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertension', 'type 2 diabetes', 'aliskiren', 'ramipril', 'microalbuminuria', 'blood pressure> 130/80 <180/105 mmHg at the end of the wash-out', 'type 2 diabetes mellitus well controlled by medication and / or', 'compliance with diet (HbA1c <7%)', 'Microalbuminuria in the upper range of normal (> 200 <300 mg/24 h)'], 'conditions': ['Hypertension', 'Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to assess the extent and trend in time of antiproteinuric effect as well as that antihypertensive effect of aliskiren 300 mg / d versus ramipril 10 mg daily in hypertensive patients with type 2 diabetes and microalbuminuria. The investigators will also evaluate:\n\n1. Average of 24 hours, as determined by ABPM, systolic and diastolic blood pressure checks at various visits\n2. Average daytime, as determined by ABPM, systolic and diastolic blood pressure checks at various visits 3. Average night, as determined by ABPM, systolic and diastolic blood pressure checks at various visits'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* blood pressure \\> 130/80 \\<180/105 mmHg at the end of the wash-out\n* type 2 diabetes mellitus well controlled by medication and / or compliance with diet (HbA1c \\<7%)\n* microalbuminuria in the upper range of normal (\\> 200 \\<300 mg/24 h)\n\nExclusion Criteria:\n\n* Pregnancy, lactation or women of childbearing age\n* Sitting diastolic blood pressure e 105 mmHg or systolic pressure e 180 at the end of the period of wash-out\n* History of hypertensive encephalopathy or cerebrovascular accident within 6 months\n* Secondary hypertension\n* Heart Failure\n* Myocardial infarction within 6 months\n* Angina pectoris, clinically significant valvular disease or arrhythmia\n* Alteration indices of liver function or renal\n* Known hypersensitivity to ACE inhibitors\n* All other physiological or pathological condition in the opinion of the physician may affect the evaluation of the parameters under study'}, 'identificationModule': {'nctId': 'NCT01038895', 'briefTitle': 'Aliskiren Versus Ramipril on Antiproteinuric Effect in Hypertensive, Type 2 Diabetic Patients With Microalbuminuria', 'organization': {'class': 'OTHER', 'fullName': 'University of Pavia'}, 'orgStudyIdInfo': {'id': 'UNIPV002DIM2009'}, 'secondaryIdInfos': [{'id': '2009-016481-83', 'type': 'REGISTRY', 'domain': '2009-016481-83'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ramipril', 'description': '10 mg/daily', 'interventionNames': ['Drug: Ramipril']}, {'type': 'EXPERIMENTAL', 'label': 'Aliskiren', 'description': '300 mg/ daily', 'interventionNames': ['Drug: Experimental']}], 'interventions': [{'name': 'Ramipril', 'type': 'DRUG', 'description': 'tablet; 10 mg; od; 3 months', 'armGroupLabels': ['Ramipril']}, {'name': 'Experimental', 'type': 'DRUG', 'description': 'tablet; 300 mg; od; 3 months', 'armGroupLabels': ['Aliskiren']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'state': 'PV', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Amedeo Mugellini, MD', 'role': 'CONTACT', 'email': 'amedeo.mugellini@unipv.it', 'phone': '+39 0382 526217'}, {'name': 'Amedeo Mugellini, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Pavia', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'centralContacts': [{'name': 'Roberto Fogari, MD', 'role': 'CONTACT', 'email': 'r.fogari@unipv.it', 'phone': '+39 0382 526217'}], 'overallOfficials': [{'name': 'Roberto Fogari, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Pavia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pavia', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'University of Pavia', 'oldOrganization': 'University of Pavia'}}}}