Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT00409851
Status:
COMPLETED
Last Update Posted:
2011-11-08
First Post:
2006-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
One Year Study to Evaluate the Safety of the Combination of Valsartan and Amlodipine in Patients With 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': 'D000068838', 'term': 'Amlodipine, Valsartan Drug Combination'}], 'ancestors': [{'id': 'D000068756', 'term': 'Valsartan'}, {'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D017311', 'term': 'Amlodipine'}, {'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D014633', 'term': 'Valine'}, {'id': 'D000597', 'term': 'Amino Acids, Branched-Chain'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1293}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-07', 'studyFirstSubmitDate': '2006-12-07', 'studyFirstSubmitQcDate': '2006-12-07', 'lastUpdatePostDateStruct': {'date': '2011-11-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline (Visit 2) in mean sitting diastolic blood pressure at trough.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline (Visit 2) in mean sitting systolic blood pressure at trough'}, {'measure': 'Change from baseline (Visit 2) in standing diastolic and systolic blood pressure at trough'}, {'measure': 'Sitting and standing pulse'}]}, 'conditionsModule': {'keywords': ['HYPERTENSION, VALSARTAN, AMLODIPINE,SAFETY'], 'conditions': ['Hypertension']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.novartisclinicaltrials.com/webapp/etrials/home.do', 'label': 'NOVARTIS PATIENT RECRUITMENT WEBSITE'}]}, 'descriptionModule': {'briefSummary': 'A ONE YEAR SAFETY STUDY FOR PATIENTS WHO COMPLETE STUDY VAA489A2201.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* SUCCESSFUL COMPLETION OF VAA489A2201 CORE TRIAL\n* VISIT 7 BLOOD PRESSURE MUST BE MSDBP ≤ 95 mmHg AND MSSBP ≤ 150 mmHg\n\nExclusion Criteria:\n\n* PATIENTS WHO EXPERIENCED ANY ADVERSE EVENTS CONSIDERED SERIOUS AND DRUG RELATED IN VAA489A2201 CORE\n* Other protocol-defined exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00409851', 'briefTitle': 'One Year Study to Evaluate the Safety of the Combination of Valsartan and Amlodipine in Patients With Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 52 Week, Open Label Extension to the Randomized, Double-blind, Multicenter, Multifactorial, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Valsartan and Amlodipine Combined and Alone in Hypertensive Patients.', 'orgStudyIdInfo': {'id': 'CVAA489A2201E1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'valsartan+amlodipine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07936', 'city': 'East Hanover', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novartis Pharmaceuticals', 'geoPoint': {'lat': 40.8201, 'lon': -74.36487}}, {'city': 'Sites in Germany', 'country': 'Germany'}], 'overallOfficials': [{'name': 'Novartis pharmaceuticals', 'role': 'STUDY_CHAIR', 'affiliation': 'Sponsor GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}