Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT00219102
Status:
COMPLETED
Last Update Posted:
2020-02-11
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Study to Evaluate Safety & Efficacy of the Combination of Aliskiren, Valsartan & Hydrochlorothiazide in Diabetic Hypertensive Nonresponder Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C446481', 'term': 'aliskiren'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 336}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-08', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-14', 'lastUpdatePostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in diastolic blood pressure after 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in systolic blood pressure after 12 weeks'}, {'measure': 'Change from baseline in systolic and diastolic blood pressure after 6 weeks'}, {'measure': 'Diastolic blood pressure of < 80 mmHg or a reduction from baseline of diastolic blood pressure of > 10 mmHg after 12 weeks'}, {'measure': 'Achieve mean sitting blood pressure control target of < 130/80 mmHg after 12 weeks'}]}, 'conditionsModule': {'keywords': ['Hypertension,', 'diabetes,', 'aliskiren,', 'blood pressure,', 'valsartan,', 'hydrochlorothiazide'], 'conditions': ['Hypertension', 'Diabetes']}, 'referencesModule': {'references': [{'pmid': '21846154', 'type': 'DERIVED', 'citation': 'Drummond W, Sirenko YM, Ramos E, Baek I, Keefe DL. Aliskiren as add-on therapy in the treatment of hypertensive diabetic patients inadequately controlled with valsartan/HCT combination: a placebo-controlled study. Am J Cardiovasc Drugs. 2011 Oct 1;11(5):327-33. doi: 10.2165/11591970-000000000-00000.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the blood pressure lowering effect and safety of aliskiren used in combination with valsartan/hydrochlorothiazide in diabetic patients with essential hypertension, not adequately responsive to the combination of valsartan and hydrochlorothiazide'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Patients with essential hypertension\n* Patients with a documented diagnosis of Type 1 or Type 2 diabetes mellitus.\n* Patients who are eligible and able to participate in the study\n\nExclusion Criteria\n\n* Severe hypertension\n* Uncontrolled diabetes type I and II\n* History or evidence of a secondary form of hypertension\n* History of Hypertensive encephalopathy or cerebrovascular accident.\n\nOther protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00219102', 'briefTitle': 'A Clinical Study to Evaluate Safety & Efficacy of the Combination of Aliskiren, Valsartan & Hydrochlorothiazide in Diabetic Hypertensive Nonresponder Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 12-week, Randomized, Double-blind, Placebo Controlled, Parallel Group Study Evaluating the Efficacy & Safety of Aliskiren in Patients With Diabetes & Hypertension Not Adequately Responsive to the Combination of Valsartan 160 mg & Hydrochlorothiazide 25 mg', 'orgStudyIdInfo': {'id': 'CSPP100A2310'}}, 'armsInterventionsModule': {'interventions': [{'name': 'aliskiren', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '28144', 'city': 'Salisbury', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 35.67097, 'lon': -80.47423}}, {'city': 'Kortrijk', 'country': 'Belgium', 'facility': 'Investigative Site', 'geoPoint': {'lat': 50.82803, 'lon': 3.26487}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Investigative Site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Investigative Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Investigative Site', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Basel', 'country': 'Switzerland', 'facility': 'Novartis Pharmaceuticals', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'city': 'Kiev', 'country': 'Ukraine', 'facility': 'Investigative Site', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}}}}