Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-01-10 @ 12:53 AM
Study NCT ID:
NCT00171405
Status:
COMPLETED
Last Update Posted:
2016-11-18
First Post:
2005-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study to Evaluate the Long-term Safety (12 Months) of the Combination of Aliskiren 300 mg and Hydrochlorothiazide 25 mg
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': {'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-16', 'studyFirstSubmitDate': '2005-08-24', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2016-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of safety through reporting of adverse events and serious adverse events, including deaths, following a 12 month study'}], 'secondaryOutcomes': [{'measure': 'Change from baseline (following a 12 month study) in mean sitting diastolic blood pressure after 4 months'}, {'measure': 'Change from baseline (following a 12 month study) in mean sitting systolic blood pressure after 4 months'}, {'measure': 'Change from baseline (following a 12 month study) in mean standing blood pressure after 4 months'}, {'measure': 'Diastolic blood pressure less than 90 mmHg or 10 mmHg or greater change from baseline'}, {'measure': 'Blood pressure less than 140/90 mmHg'}]}, 'conditionsModule': {'keywords': ['hypertension', 'aliskiren', 'hydrochlorothiazide'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '22035463', 'type': 'RESULT', 'citation': 'Sica D, Gradman AH, Lederballe O, Kolloch RE, Zhang J, Keefe DL. Long-term safety and tolerability of the oral direct renin inhibitor aliskiren with optional add-on hydrochlorothiazide in patients with hypertension: a randomized, open-label, parallel-group, multicentre, dose-escalation study with an extension phase. Clin Drug Investig. 2011 Dec 1;31(12):825-37. doi: 10.1007/BF03256921.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to collect the long-term (12 months) safety data on aliskiren 300 mg when taken in combination with HCTZ 25 mg.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. their successful completion of the CSPP100A2302 core study with at least eight months combination treatment of aliskiren 300 mg and HCTZ 25 mg, i.e., patients who received aliskiren 300 mg and HCTZ 25 mg at Month 4 of the core study and complete the core study.\n2. absence of ongoing severe adverse events at Visit 10.'}, 'identificationModule': {'nctId': 'NCT00171405', 'briefTitle': 'A Clinical Study to Evaluate the Long-term Safety (12 Months) of the Combination of Aliskiren 300 mg and Hydrochlorothiazide 25 mg', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 4 Month Extension to a 12 Month, Randomized, Open-label, Multicenter, Study to Assess the Long-term Safety of Aliskiren 150 mg Alone and 300 mg Alone or With the Optional Addition of Hydrochlorothiazide (12.5 mg or 25 mg) in Patients With Essential Hypertension', 'orgStudyIdInfo': {'id': 'CSPP100A2302E1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'aliskiren', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'East Hanover', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 40.8201, 'lon': -74.36487}}, {'city': 'Deurne', 'country': 'Belgium', 'facility': 'Investigative Site', 'geoPoint': {'lat': 51.22134, 'lon': 4.46595}}, {'city': 'Ste-Fov', 'country': 'Canada', 'facility': 'Investigative Site'}, {'city': 'Krassel', 'country': 'Germany', 'facility': 'Investigative Site'}, {'city': 'Broni', 'country': 'Italy', 'facility': 'Investigative Site', 'geoPoint': {'lat': 45.06394, 'lon': 9.25993}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Investigative Site', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Lima', 'country': 'Peru', 'facility': 'Investigative Site', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Investigative Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Basel', 'country': 'Switzerland', 'facility': 'Investigative Site', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Investigative Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}}}}