Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-03 @ 11:26 PM
Study NCT ID:
NCT00548067
Status:
COMPLETED
Last Update Posted:
2010-09-27
First Post:
2007-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Drug Interaction Study Following Co-administration of Valsartan, Hydrochlorothiazide 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': 'D000068756', 'term': 'Valsartan'}, {'id': 'D006852', 'term': 'Hydrochlorothiazide'}, {'id': 'D000068838', 'term': 'Amlodipine, Valsartan Drug Combination'}, {'id': 'D017311', 'term': 'Amlodipine'}], 'ancestors': [{'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'D002740', 'term': 'Chlorothiazide'}, {'id': 'D001581', 'term': 'Benzothiadiazines'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D049971', 'term': 'Thiazides'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'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': 111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-24', 'studyFirstSubmitDate': '2007-10-22', 'studyFirstSubmitQcDate': '2007-10-22', 'lastUpdatePostDateStruct': {'date': '2010-09-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Potential drug interaction and effect on blood level of drugs when co-administered for 17 days'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability of co-administered assessed by capturing adverse events and safety laboratory'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['High blood pressure, hypertension, drug interaction, steady state, valsartan, hydrochlorothiazide, amlodipine'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine potential pharmacokinetic drug-drug interaction when three drugs (valsartan, amlodipine, and hydrochlorothiazide) are co-administered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients diagnosed as hypertensive\n\n* Untreated confirmed hypertensive patients (consistent SBP \\>140 mm Hg or DBP \\>90 mm Hg)\n* Uncontrolled hypertensive patients (Consistent SBP \\>140 mm Hg or DBP \\>90 mm Hg) on one drug therapy.\n* Uncontrolled hypertensive patients (Consistent SBP \\>140 mm Hg or DBP \\>90 mm Hg) on two drug therapy.\n\nExclusion Criteria:\n\n* Inability to switch from all prior antihypertensive medications safely as required by the protocol.\n* Need for drugs other than study drugs at the time of baseline.\n* Patients with SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg at screening.\n* Patients on four or more antihypertensive drugs at screening.\n* Pregnant or nursing (lactating) women.\n* Patients with diabetes mellitus\n* Patients with heart diseases and any other disease\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00548067', 'briefTitle': 'Pharmacokinetic Drug Interaction Study Following Co-administration of Valsartan, Hydrochlorothiazide and Amlodipine in Patients With Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Multi-center, Multiple Dose, Open-label, Four-cohort, Parallel Study to Assess the Pharmacokinetic Drug Interaction Following Co-administration of Valsartan, Hydrochlorothiazide and Amlodipine in Patients With Hypertension.', 'orgStudyIdInfo': {'id': 'CVEA489A2104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: Valsartan/hydrochlorothiazide (HCTZ)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Valsartan/amlodipine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'interventionNames': ['Drug: Amlodipine/hydrochlorothiazide(HCTZ)']}, {'type': 'EXPERIMENTAL', 'label': '4', 'interventionNames': ['Drug: Valsartan/amlodipine/hydrochlorothiazide(HCTZ)']}], 'interventions': [{'name': 'Valsartan/hydrochlorothiazide (HCTZ)', 'type': 'DRUG', 'armGroupLabels': ['1']}, {'name': 'Valsartan/amlodipine', 'type': 'DRUG', 'armGroupLabels': ['2']}, {'name': 'Amlodipine/hydrochlorothiazide(HCTZ)', 'type': 'DRUG', 'armGroupLabels': ['3']}, {'name': 'Valsartan/amlodipine/hydrochlorothiazide(HCTZ)', 'type': 'DRUG', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ahmedabad', 'country': 'India', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'city': 'Bangalore', 'country': 'India', 'facility': 'Novartis investigative site', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'city': 'Hyderabad', 'country': 'India', 'facility': 'Novartis Investigative site', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'city': 'Mangalore', 'country': 'India', 'facility': 'Novartis Investigative site', 'geoPoint': {'lat': 12.91723, 'lon': 74.85603}}, {'city': 'Mehasana', 'country': 'India', 'facility': 'Novartis investigative site'}], 'overallOfficials': [{'name': 'Novartis', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Novartis investigative site'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'External Affairs', 'oldOrganization': 'Novartis'}}}}