Ignite Creation Date:
2025-12-24 @ 9:27 PM
Ignite Modification Date:
2026-02-23 @ 4:55 AM
Study NCT ID:
NCT00233532
Status:
COMPLETED
Last Update Posted:
2008-07-22
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Canadian Study of Trandolapril on Blood Pressure in Hypertensive Patients (TRAIL)
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': 'C052035', 'term': 'trandolapril'}, {'id': 'D014700', 'term': 'Verapamil'}], 'ancestors': [{'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'lastUpdateSubmitDate': '2008-07-18', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-10-05', 'lastUpdatePostDateStruct': {'date': '2008-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness of escalating dose regimen of trandolapril in controlling blood pressure', 'timeFrame': '14 weeks'}], 'secondaryOutcomes': [{'measure': 'Changes in blood pressure, safety.', 'timeFrame': '14 and 26 weeks'}, {'measure': 'BP mmHg incremental and absolute change', 'timeFrame': '14 and 26 weeks'}, {'measure': 'Adverse events', 'timeFrame': 'Throughout 26 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Trandolapril'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The TRAIL study was conducted to examine the effects of escalating doses of an ACE inhibitor, trandolapril, on lowering blood pressure in Stage 1-2 hypertensive patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stage 1 or 2 Hypertension\n\nExclusion Criteria:\n\n* Uncontrolled diabetes\n* Subject has a hypersensitivity to ACE inhibitor'}, 'identificationModule': {'nctId': 'NCT00233532', 'acronym': 'TRAIL', 'briefTitle': 'Canadian Study of Trandolapril on Blood Pressure in Hypertensive Patients (TRAIL)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'A Prospective, Open-Label Study to Evaluate the Effect of an Escalating Dose Regimen of Trandolapril on Blood Pressure in Treatment-Naïve and Concurrently Treated Hypertensive Patients (TRAIL)', 'orgStudyIdInfo': {'id': 'CANA-03-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'interventionNames': ['Drug: Trandolapril']}, {'type': 'OTHER', 'label': '2', 'interventionNames': ['Drug: Trandolapril']}, {'type': 'OTHER', 'label': '3', 'interventionNames': ['Drug: Trandolapril']}], 'interventions': [{'name': 'Trandolapril', 'type': 'DRUG', 'otherNames': ['ABT-TARKA', 'trandolapril/verapamil', 'TARKA'], 'description': '0.5, 1,2,4mg/once daily/ for 26 weeks (If BP was not controlled, dose was escalated to the next higher dosage every 4-5 weeks).', 'armGroupLabels': ['1', '2', '3']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Global Medical Information 1-800-633-9110', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Anita Vanjaka, Clinical Research Manager', 'oldOrganization': 'Abbott'}}}}