Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-28 @ 2:00 AM
Study NCT ID:
NCT00219050
Status:
COMPLETED
Last Update Posted:
2011-02-25
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study to Compare the Safety and Efficacy of an Aliskiren-based Regimen With a Lisinopril Based Regimen in Patients With Severe Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular 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': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-24', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-14', 'lastUpdatePostDateStruct': {'date': '2011-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate safety through adverse events and laboratory abnormalities after 8 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in diastolic blood pressure after 8 weeks'}, {'measure': 'Change from baseline in systolic blood pressure after 8 weeks'}, {'measure': 'Change from baseline in standing systolic blood and diastolic pressure after 8 weeks'}, {'measure': 'Diastolic blood pressure is less than 90 mmHg or reduction of 10 mmHg or greater from baseline after 8 weeks'}]}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '40013543', 'type': 'DERIVED', 'citation': 'Wang GM, Li LJ, Fan L, Xu M, Tang WL, Wright JM. Renin inhibitors versus angiotensin receptor blockers for primary hypertension. Cochrane Database Syst Rev. 2025 Feb 27;2(2):CD012570. doi: 10.1002/14651858.CD012570.pub2.'}, {'pmid': '33089502', 'type': 'DERIVED', 'citation': 'Wang GM, Li LJ, Tang WL, Wright JM. Renin inhibitors versus angiotensin converting enzyme (ACE) inhibitors for primary hypertension. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD012569. doi: 10.1002/14651858.CD012569.pub2.'}]}, 'descriptionModule': {'briefSummary': 'To compare the safety and efficacy of an aliskiren-based regimen to a lisinopril-based regimen in the treatment of severe hypertension'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Patients with essential severe hypertension Exclusion Criteria\n* History or evidence of a secondary form of hypertension\n* History of hypertensive encephalopathy or cerebrovascular accident.\n* Diabetic patients requiring insulin Other protocol-defined inclusion/exclusion criteria also apply'}, 'identificationModule': {'nctId': 'NCT00219050', 'briefTitle': 'A Clinical Study to Compare the Safety and Efficacy of an Aliskiren-based Regimen With a Lisinopril Based Regimen in Patients With Severe Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'An Eight-week, Randomized, Double-blind, Multi-center, Active-controlled, Parallel Group Study to Evaluate the Safety and Efficacy of an Aliskiren-based Regimen Compared to a Lisinopril-based Regimen in Patients With Uncomplicated Severe Hypertension', 'orgStudyIdInfo': {'id': 'CSPP100A2303'}}, 'armsInterventionsModule': {'interventions': [{'name': 'aliskiren', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': 'Investigative Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Investigative Site', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Investigative Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Basel', 'country': 'Switzerland', 'facility': 'Novartis Pharmaceuticals', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'External Affairs', 'oldOrganization': 'Novartis'}}}}