Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:10 AM
Study NCT ID:
NCT05195827
Status:
WITHDRAWN
Last Update Posted:
2023-03-20
First Post:
2022-01-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of PRM-125 on Ambulatory Blood Pressure
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Sponsor', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-16', 'studyFirstSubmitDate': '2022-01-02', 'studyFirstSubmitQcDate': '2022-01-13', 'lastUpdatePostDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in 24 hour Systolic Blood Pressure', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in 24 hour Diastolic Blood Pressure', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'Evaluation of Once-Daily PRM125 On Ambulatory Blood Pressure in Adults with Hypertension', 'detailedDescription': 'Approximately 60 subjects with primary hypertension are treated for 8 weeks with PRM125 to determine if Ambulatory Blood Pressure is changed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary hypertension\n\nExclusion Criteria:\n\n* medical conditions that preclude evaluation and/or adversely effect subject safety'}, 'identificationModule': {'nctId': 'NCT05195827', 'briefTitle': 'Effect of PRM-125 on Ambulatory Blood Pressure', 'organization': {'class': 'INDUSTRY', 'fullName': 'PRM Pharma, LLC'}, 'officialTitle': 'Evaluation of Once-Daily PRM125 On Ambulatory Blood Pressure in Adults With Hypertension', 'orgStudyIdInfo': {'id': 'CTD-3001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRM125', 'description': 'PRM125', 'interventionNames': ['Drug: PRM-125']}], 'interventions': [{'name': 'PRM-125', 'type': 'DRUG', 'description': 'Antihypertensive', 'armGroupLabels': ['PRM125']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'AMR', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PRM Pharma, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}