Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 11:34 PM
Study NCT ID:
NCT00367094
Status:
COMPLETED
Last Update Posted:
2007-07-09
First Post:
2006-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of Benazepril Plus Hydrochlorothiazide in Chinese Patients With Mild to Moderate Essential 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': 'C044946', 'term': 'benazepril'}, {'id': 'D006852', 'term': 'Hydrochlorothiazide'}], 'ancestors': [{'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': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 296}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'lastUpdateSubmitDate': '2007-07-06', 'studyFirstSubmitDate': '2006-08-21', 'studyFirstSubmitQcDate': '2006-08-21', 'lastUpdatePostDateStruct': {'date': '2007-07-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in diastolic blood pressure from baseline to week 8'}], 'secondaryOutcomes': [{'measure': 'Change in systolic blood pressure from baseline to week 8'}, {'measure': 'Proportion of patients with blood pressure less than 140/90 mmHg at week 8'}, {'measure': 'Ambulant blood pressure monitoring profiles at baseline and week 8'}]}, 'conditionsModule': {'keywords': ['Hypertension, benazepril, hydrochlorothiazide, fixed combination'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'This study will evaluate efficacy and safety data for benazepril/hydrochlorothiazide in adult Chinese patients with mild to moderate essential hypertension. Patients whose blood pressure is not adequately controlled with benazepril monotherapy during a 4 week run-in period will be randomly allocated to double blind treatment over 8 weeks with either a combination of benazepril/hydrochlorothiazide per day or continuation of benazepril per day.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients, age 18 or older\n* Given informed consent\n* Diagnosed as having mild to moderate essential hypertension\n\nExclusion Criteria:\n\n* Severe hypertension\n* Significant preexisting cardiovascular and cerebrovascular disease\n* Diabetes mellitus type 1 or poorly controlled diabetes mellitus type II\n* Advanced renal impairment\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00367094', 'briefTitle': 'Combination of Benazepril Plus Hydrochlorothiazide in Chinese Patients With Mild to Moderate Essential Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Efficacy and Safety of the Combination of Benazepril Plus Hydrochlorothiazide in Chinese Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Benazepril', 'orgStudyIdInfo': {'id': 'CLHT344ACN01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Benazepril plus hydrochlorothiazide', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Novartis', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}}}}