Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
Study NCT ID:
NCT00353912
Status:
COMPLETED
Last Update Posted:
2016-11-18
First Post:
2006-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy & Safety of Orally Administered Valsartan/Amlodipine Combo Therapy vs Amlodipine Monotherapy in Black Patients With Stage II Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D054160', 'term': 'Systolic Murmurs'}, {'id': 'D006337', 'term': 'Heart Murmurs'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 571}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-16', 'studyFirstSubmitDate': '2006-07-17', 'studyFirstSubmitQcDate': '2006-07-17', 'lastUpdatePostDateStruct': {'date': '2016-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in MSSBP at week 8'}], 'secondaryOutcomes': [{'measure': 'change from baseline MSSBP after 2, 4 and 12 weeks of treatment'}, {'measure': 'change from baseline MSDBP after 2, 4, 8 and 12 weeks of treatment'}, {'measure': 'proportion of patients reaching overall BP control (MSSBP < 140 mmHg and MSDBP < 90mmHg) after 12 weeks of treatment'}, {'measure': 'evaluation of safety and tolerability after 12 weeks of treatment'}]}, 'conditionsModule': {'keywords': ['Blood', 'Venous', 'Systolic', 'Diastolic', 'Pulse', 'Pressure'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '19190658', 'type': 'RESULT', 'citation': 'Flack JM, Calhoun DA, Satlin L, Barbier M, Hilkert R, Brunel P. Efficacy and safety of initial combination therapy with amlodipine/valsartan compared with amlodipine monotherapy in black patients with stage 2 hypertension: the EX-STAND study. J Hum Hypertens. 2009 Jul;23(7):479-89. doi: 10.1038/jhh.2008.153. Epub 2009 Jan 29.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the blood pressure lowering effects of a valsartan/amlodipine combination treatment and amlodipine monotherapy for the treatment of Black stage II hypertensive patients (MSSBP ≥ 160 mmHg).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older.\n* Moderate to severe high blood pressure. This is defined as a systolic pressure (the top number) greater than or equal to 160 mmHg and less than 200 mmHg.\n\nExclusion Criteria:\n\n* History of allergy or hypersensitivity to ARBs, CCBs, thiazide diuretics\n* Inability to stop all prior blood pressure medications safely\n* Systolic BP ≥ 200 mmHg and/or diastolic BP ≥ 120 mmHg\n* Controlled blood pressure (systolic BP \\< 140 mmHg) taking more than 3 antihypertensive medications at screening\n* Systolic BP ≥ 140 mmHg and \\< 180 mmHg taking more than two antihypertensive medications at screening\n* Systolic BP ≥ 180 mmHg taking more than one antihypertensive medication at screening\n* History of autoimmune diseases\n* History of multiple drug allergies\n* Liver disease\n* Pancreatic injury within 1 year of screening\n* Evidence of kidney impairment or history of dialysis\n* Any surgical or medical condition which might alter the absorption, distribution, metabolism, or excretion of any drug. This could include currently active gastritis, ulcers, or gastrointestinal/rectal bleeding, or urinary tract obstruction.\n* Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, would be excluded UNLESS they are post-menopausal, surgically sterile OR are using acceptable methods of contraception. The use of hormonal contraceptives is not allowed\n* Pregnant or nursing (lactating) women\n* History of malignancy of any organ system within the past five years\n* Any severe, life-threatening disease within the past five years\n* History of drug or alcohol abuse within the last 2 years.\n* History of stroke, angioplasty, coronary artery bypass graft surgery, heart attack or unstable angina\n* Type 1 diabetes\n* Poorly controlled Type 2 diabetes\n* History of heart failure\n* Arrhythmia\n* Significant valvular heart disease\n* Active gout\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00353912', 'briefTitle': 'Efficacy & Safety of Orally Administered Valsartan/Amlodipine Combo Therapy vs Amlodipine Monotherapy in Black Patients With Stage II Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 12-week, Multicenter Study to Evaluate the Efficacy and Safety of Orally Administered Valsartan/Amlodipine Combo Based Therapy vs Amlodipine Monotherapy in Black Patients With Stage II Hypertension', 'orgStudyIdInfo': {'id': 'CVAA489A2402'}}, '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}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}