Ignite Creation Date:
2025-12-24 @ 12:16 PM
Ignite Modification Date:
2025-12-27 @ 9:28 PM
Study NCT ID:
NCT07090161
Status:
RECRUITING
Last Update Posted:
2025-12-02
First Post:
2025-07-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Efficacy and Safety of Iloperidone for the Treatment of Participants With Uncontrolled 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': 'C081732', 'term': 'iloperidone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2025-07-22', 'studyFirstSubmitQcDate': '2025-07-22', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline to treatment week 4 in SiSBP', 'timeFrame': 'screening to treatment week 4'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['iloperidone', 'hypertension', 'uncontrolled hypertension'], 'conditions': ['Hypertension', 'Uncontrolled Hypertension']}, 'descriptionModule': {'briefSummary': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Iloperidone for the Treatment of Participants with Uncontrolled Hypertension'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* SiSBP \\>/= 130 mmHg despite \\>8 weeks treatment w/ 1 or more antihypertensive therapies\n\nExclusion Criteria:\n\n* Confirmed Grade 3/severe hypertension (SiSBP \\>/= 180 mmHg, SiDBP \\>/= 120 mmHg), unstable cardiac disease, renal insufficiency'}, 'identificationModule': {'nctId': 'NCT07090161', 'briefTitle': 'Evaluation of Efficacy and Safety of Iloperidone for the Treatment of Participants With Uncontrolled Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vanda Pharmaceuticals'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Iloperidone for the Treatment of Participants With Uncontrolled Hypertension', 'orgStudyIdInfo': {'id': 'VP-VYV-683-2401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental/Iloperidone', 'interventionNames': ['Drug: iloperidone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comparator', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'iloperidone', 'type': 'DRUG', 'otherNames': ['Fanapt'], 'description': 'iloperidone', 'armGroupLabels': ['Experimental/Iloperidone']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo comparator', 'armGroupLabels': ['Placebo Comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85053', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Vanda Investigative Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85281', 'city': 'Tempe', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Vanda Investigative Site', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '91910', 'city': 'Chula Vista', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Vanda Investigative Site', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '94568', 'city': 'Dublin', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Vanda Investigative Site', 'geoPoint': {'lat': 37.70215, 'lon': -121.93579}}, {'zip': '33912', 'city': 'Fort Myers', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Vanda Investigative Site', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '31904', 'city': 'Columbus', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Vanda Investigative Site', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '60477', 'city': 'Tinley Park', 'state': 'Illinois', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Vanda Investigative Site', 'geoPoint': {'lat': 41.57337, 'lon': -87.78449}}, {'zip': '67207', 'city': 'Wichita', 'state': 'Kansas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Vanda Investigative Site', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '63042', 'city': 'Hazelwood', 'state': 'Missouri', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Vanda Investigative Site', 'geoPoint': {'lat': 38.77144, 'lon': -90.37095}}, {'zip': '10549', 'city': 'Mount Kisco', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Vanda Investigative Site', 'geoPoint': {'lat': 41.20426, 'lon': -73.72708}}, {'zip': '28501', 'city': 'Kinston', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Vanda Investigative Site', 'geoPoint': {'lat': 35.26266, 'lon': -77.58164}}, {'zip': '45212', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Vanda Investigative Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '73069', 'city': 'Norman', 'state': 'Oklahoma', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Vanda Investigative Site', 'geoPoint': {'lat': 35.22257, 'lon': -97.43948}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Vanda Investigative Site', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '29414', 'city': 'Charleston', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Vanda Investigative Site', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '22015', 'city': 'Burke', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Vanda Investigative Site', 'geoPoint': {'lat': 38.79345, 'lon': -77.27165}}], 'centralContacts': [{'name': 'Vanda Pharmaceuticals, Inc.', 'role': 'CONTACT', 'email': 'clinicaltrials@vandapharma.com', 'phone': '202-734-3400'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanda Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}