Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2026-02-26 @ 8:11 PM
Study NCT ID:
NCT01835418
Status:
UNKNOWN
Last Update Posted:
2013-04-19
First Post:
2013-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bedtime Administration of Amlodipine Versus Lisinopril
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-11-23', 'releaseDate': '2016-10-05'}, {'resetDate': '2017-07-25', 'releaseDate': '2017-06-26'}, {'resetDate': '2022-12-28', 'releaseDate': '2022-12-05'}, {'resetDate': '2023-01-23', 'releaseDate': '2022-12-29'}, {'resetDate': '2023-02-21', 'releaseDate': '2023-01-30'}, {'resetDate': '2023-04-05', 'releaseDate': '2023-03-15'}, {'resetDate': '2023-06-12', 'releaseDate': '2023-05-22'}], 'estimatedResultsFirstSubmitDate': '2016-10-05'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017311', 'term': 'Amlodipine'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'lastUpdateSubmitDate': '2013-04-18', 'studyFirstSubmitDate': '2013-02-21', 'studyFirstSubmitQcDate': '2013-04-18', 'lastUpdatePostDateStruct': {'date': '2013-04-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in mean sleep-time systolic blood pressure after addition of a bedtime dose of amlodipine versus lisinopril', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Changes in mean sleep-time diastolic, awake systolic and diastolic blood pressures, including comparison of % achieving target BP', 'timeFrame': '1 year'}, {'measure': 'Impact of individual medications on sleep-time blood pressure drop (dipping status)', 'timeFrame': '1 year'}, {'measure': 'Association of baseline renin levels to sleep-time blood pressure drop', 'timeFrame': '1 year'}, {'measure': 'Association of baseline renin levels with response to amlodipine versus lisinopril', 'timeFrame': '1 year'}, {'measure': 'Association of baseline dipping status with response to amlodipine versus lisinopril', 'timeFrame': '1 year'}, {'measure': 'Association of age and response to amlodipine versus lisinopril', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['managed with bedtime administration of lisinopril versus amlodipine'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'This study seeks to compare the differences in effectiveness among individual patients treated at for hypertension with bedtime administration of amlodipine versus lisinopril. There will be an analysis of whether one medication was more effective than another and whether specific patient factors could predict who responded better to which one.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 40 to 80\n* Newly diagnosed hypertension based on 24 hour ambulatory blood pressure monitor criteria.\n* Minimum Asleep SBP mean of ≥ 120mmHg for inclusion.\n\nExclusion Criteria:\n\n* Current antihypertensive medication use\n* Baseline GFR \\< 45\n* Preexisting macroproteinuria\n* Chronic congestive heart failure\n* History of CVA\n* Diabetes Mellitus\n* Pregnancy\n* Night-shift work\n* Other preexisting contraindication to amlodipine or lisinopril'}, 'identificationModule': {'nctId': 'NCT01835418', 'acronym': 'BAVLART', 'briefTitle': 'Bedtime Administration of Amlodipine Versus Lisinopril', 'organization': {'class': 'OTHER', 'fullName': 'Allina Health System'}, 'officialTitle': 'Bedtime Administration of Amlodipine Versus Lisinopril: a Randomized Trial', 'orgStudyIdInfo': {'id': '9529148100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lisinopril', 'description': 'bedtime administration of lisinopril 20mg', 'interventionNames': ['Drug: Amlodipine']}, {'type': 'EXPERIMENTAL', 'label': 'Amlodipine', 'description': 'Bedtime administration of amlodipine 5mg', 'interventionNames': ['Drug: Amlodipine']}], 'interventions': [{'name': 'Amlodipine', 'type': 'DRUG', 'description': 'crossover comparison of amlodipine vs lisinopril', 'armGroupLabels': ['Amlodipine', 'Lisinopril']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allina Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'David Ingham', 'investigatorAffiliation': 'Allina Health System'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-10-05', 'type': 'RELEASE'}, {'date': '2016-11-23', 'type': 'RESET'}, {'date': '2017-06-26', 'type': 'RELEASE'}, {'date': '2017-07-25', 'type': 'RESET'}, {'date': '2022-12-05', 'type': 'RELEASE'}, {'date': '2022-12-28', 'type': 'RESET'}, {'date': '2022-12-29', 'type': 'RELEASE'}, {'date': '2023-01-23', 'type': 'RESET'}, {'date': '2023-01-30', 'type': 'RELEASE'}, {'date': '2023-02-21', 'type': 'RESET'}, {'date': '2023-03-15', 'type': 'RELEASE'}, {'date': '2023-04-05', 'type': 'RESET'}, {'date': '2023-05-22', 'type': 'RELEASE'}, {'date': '2023-06-12', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Allina Health System'}}}}