Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2025-12-29 @ 11:20 PM
Study NCT ID:
NCT01658657
Status:
COMPLETED
Last Update Posted:
2015-08-27
First Post:
2012-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Pilot Study of Plasma Renin Activity Guided vs Generic Combination Therapy for Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D006852', 'term': 'Hydrochlorothiazide'}, {'id': 'D017706', 'term': 'Lisinopril'}, {'id': 'D017311', 'term': 'Amlodipine'}, {'id': 'D008790', 'term': 'Metoprolol'}, {'id': 'C091365', 'term': 'hydrochlorothiazide, lisinopril drug combination'}], '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'}, {'id': 'D004151', 'term': 'Dipeptides'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'viera@med.unc.edu', 'phone': '919-966-0758', 'title': 'Anthony Viera', 'organization': 'UNC Chapel Hil'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'PRA-guided Therapy', 'description': 'Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.\n\nHydrochlorothiazide\n\nLisinopril\n\nAmlodipine\n\nmetoprolol', 'otherNumAtRisk': 7, 'otherNumAffected': 3, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Fixed-dose Combination Treatment-guided Therapy', 'description': 'Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level.\n\nAmlodipine\n\nmetoprolol\n\nlisinopril/hydrochlorothiazide', 'otherNumAtRisk': 10, 'otherNumAffected': 4, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Electrolyte disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lightheadedness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Blood Pressure Control, as Defined as Office BP Measurement of <140 mmHg Systolic and <90 mmHg Diastolic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PRA-guided Therapy', 'description': 'Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.\n\nHydrochlorothiazide\n\nLisinopril\n\nAmlodipine\n\nmetoprolol'}, {'id': 'OG001', 'title': 'Fixed-dose Combination Treatment-guided Therapy', 'description': 'Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level.\n\nAmlodipine\n\nmetoprolol\n\nlisinopril/hydrochlorothiazide'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 months', 'description': "At each study visit (approximately every 30 days), participants' BP will be checked. If BP is controlled (\\<140mmHG systolic and \\<90mmHG diastolic), then current medication will continue. If BP is uncontrolled, medication will be revised every 30 days (up to 120) until BP control is achieved.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '6 participants withdrawn before study completion'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PRA-guided Therapy', 'description': 'Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.\n\nHydrochlorothiazide\n\nLisinopril\n\nAmlodipine\n\nmetoprolol'}, {'id': 'FG001', 'title': 'Fixed-dose Combination Treatment-guided Therapy', 'description': 'Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level.\n\nAmlodipine\n\nmetoprolol\n\nlisinopril/hydrochlorothiazide'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PRA-guided Therapy', 'description': 'Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.\n\nHydrochlorothiazide\n\nLisinopril\n\nAmlodipine\n\nmetoprolol'}, {'id': 'BG001', 'title': 'Fixed-dose Combination Treatment-guided Therapy', 'description': 'Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level.\n\nAmlodipine\n\nmetoprolol\n\nlisinopril/hydrochlorothiazide'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.6', 'groupId': 'BG000', 'lowerLimit': '35', 'upperLimit': '59'}, {'value': '46.7', 'groupId': 'BG001', 'lowerLimit': '27', 'upperLimit': '67'}, {'value': '47', 'groupId': 'BG002', 'lowerLimit': '27', 'upperLimit': '67'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-17', 'studyFirstSubmitDate': '2012-07-31', 'resultsFirstSubmitDate': '2015-06-03', 'studyFirstSubmitQcDate': '2012-08-02', 'lastUpdatePostDateStruct': {'date': '2015-08-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-06-03', 'studyFirstPostDateStruct': {'date': '2012-08-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Pressure Control, as Defined as Office BP Measurement of <140 mmHg Systolic and <90 mmHg Diastolic', 'timeFrame': '4 months', 'description': "At each study visit (approximately every 30 days), participants' BP will be checked. If BP is controlled (\\<140mmHG systolic and \\<90mmHG diastolic), then current medication will continue. If BP is uncontrolled, medication will be revised every 30 days (up to 120) until BP control is achieved."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertension', 'Plasma Renin Activity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of plasma renin activity-guided therapy for determining hypertension treatment. Plasma renin is an enzyme in your blood that can be measured to determine your hypertension subtype. Once the subtype is known, doctors can prescribe specific medications to target your specific hypertension subtype. This study will investigate whether targeting the specific hypertension subtype helps to achieve blood pressure control sooner and with fewer medications compared to a standard fixed dose combination therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Systolic BP average during at least one recent (within 1 month) clinic or emergency room visit ≥ 150 mmHg, or diastolic BP average during at least one recent (within 1 month) clinic or emergency room visit ≥ 95 mmHg\n* Not currently taking BP-lowering medication\n* Clinician recommends pharmacologic treatment\n* Willing to make necessary study visits\n* Able to be contacted by phone\n* Has a primary care clinician\n* At least 18 years old\n\nExclusion Criteria:\n\n* Known secondary cause of hypertension\n* Pregnancy\n* Known diabetes, coronary artery disease or renal disease\n* Known sulfonamide allergy or history of gout\n* Participant's clinician recommends he/she not enroll\n* Hyponatremia, hypokalemia, hypernatremia, or hyperglycemia at baseline visit\n* Baseline visit systolic visit BP average \\< 140 mmHg and diastolic BP average \\< 90 mm Hg\n* Resting heart rate \\< 55 beats per minute"}, 'identificationModule': {'nctId': 'NCT01658657', 'briefTitle': 'A Pilot Study of Plasma Renin Activity Guided vs Generic Combination Therapy for Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'A Pilot Study of Plasma Renin Activity Guided vs Generic Combination Therapy for Hypertension', 'orgStudyIdInfo': {'id': '12-1133'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRA-guided therapy', 'description': 'Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.', 'interventionNames': ['Drug: Hydrochlorothiazide', 'Drug: Lisinopril', 'Drug: Amlodipine', 'Drug: metoprolol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fixed-dose combination treatment-guided therapy', 'description': 'Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level.', 'interventionNames': ['Drug: Amlodipine', 'Drug: metoprolol', 'Drug: lisinopril/hydrochlorothiazide']}], 'interventions': [{'name': 'Hydrochlorothiazide', 'type': 'DRUG', 'armGroupLabels': ['PRA-guided therapy']}, {'name': 'Lisinopril', 'type': 'DRUG', 'armGroupLabels': ['PRA-guided therapy']}, {'name': 'Amlodipine', 'type': 'DRUG', 'armGroupLabels': ['Fixed-dose combination treatment-guided therapy', 'PRA-guided therapy']}, {'name': 'metoprolol', 'type': 'DRUG', 'armGroupLabels': ['Fixed-dose combination treatment-guided therapy', 'PRA-guided therapy']}, {'name': 'lisinopril/hydrochlorothiazide', 'type': 'DRUG', 'description': 'This is a combination pill', 'armGroupLabels': ['Fixed-dose combination treatment-guided therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Anthony Viera, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Distinguished Associate Professor, Family Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cornell University', 'class': 'OTHER'}, {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Distinguished Associate Professor', 'investigatorFullName': 'Anthony J Viera, MD, MPH', 'investigatorAffiliation': 'University of North Carolina, Chapel Hill'}}}}