Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2025-12-25 @ 7:37 PM
Study NCT ID:
NCT00299832
Status:
COMPLETED
Last Update Posted:
2016-11-18
First Post:
2006-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SPP100 (Aliskiren) Regimen in Hypertensive Patients With Renal Dysfunction
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-16', 'studyFirstSubmitDate': '2006-03-03', 'studyFirstSubmitQcDate': '2006-03-03', 'lastUpdatePostDateStruct': {'date': '2016-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events after 8 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in mean sitting systolic blood pressure after 8 weeks'}, {'measure': 'Change from baseline in mean sitting diastolic blood pressure after 8 weeks'}, {'measure': 'Mean sitting systolic blood pressure is < 140 mmHg or a reduction of > 20 mmHg after 8 weeks'}, {'measure': 'Mean sitting diastolic blood pressure is < 90 mmHg or a reduction of > 10 mmHg after 8 weeks'}, {'measure': 'Blood pressure <140/90 after 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertension, aliskiren, blood pressure, rennin'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '19927154', 'type': 'RESULT', 'citation': 'Ito S, Nakura N, Le Breton S, Keefe D. Efficacy and safety of aliskiren in Japanese hypertensive patients with renal dysfunction. Hypertens Res. 2010 Jan;33(1):62-6. doi: 10.1038/hr.2009.175. Epub 2009 Nov 20.'}]}, 'descriptionModule': {'briefSummary': 'Assessing the safety, efficacy and pharmacokinetics of SPP100 (Aliskiren) regimen in hypertensive patients with renal dysfunction'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 20 - 80 years old\n* Gender: Male or female\n* Status: Outpatients\n* Elevated Serum Creatinine\n\nExclusion Criteria:\n\n* Patients suspected of malignant hypertension\n* Patients with a clinically significant allergy\n* Patients who have received other investigational drug Other protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00299832', 'briefTitle': 'SPP100 (Aliskiren) Regimen in Hypertensive Patients With Renal Dysfunction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': "A Multi-center, Open-label Study Assessing the Safety, Efficacy and Pharmacokinetics of 8 Week's Treatment of SPP100 (Aliskiren) Regimen in Hypertensive Patients With Renal Dysfunction", 'orgStudyIdInfo': {'id': 'CSPP100A1303'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Aliskiren', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Japan', 'country': 'Japan', 'facility': 'Novartis Pharmaceuticals'}], 'overallOfficials': [{'name': 'Novartis', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}