Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:17 AM
Study NCT ID:
NCT07374861
Status:
RECRUITING
Last Update Posted:
2026-01-29
First Post:
2026-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Bempedoic Acid in Italy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C581236', 'term': '8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-21', 'studyFirstSubmitDate': '2026-01-21', 'studyFirstSubmitQcDate': '2026-01-21', 'lastUpdatePostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Description of adherence to treatment with Bempedoic acid in a real-life Italian population', 'timeFrame': '6-12-24-36 months', 'description': 'Adherence will be assessed in terms of Medical Possession Ratio (MPR), which is defined as the ratio between the treatment units dispensed during the treatment period and the duration of the treatment period itself.'}, {'measure': 'Description of efficacy of treatment with Bempedoic acid in a real-life Italian population', 'timeFrame': '6-12-24-36 months', 'description': 'Efficacy of treatment will be evaluated as a change in the LDL (deltaLDL) value from the start of treatment (percentage and absolute value).'}, {'measure': 'Description of persistence to treatment with Bempedoic acid in a real-life Italian population', 'timeFrame': '6-12-24-36 months', 'description': 'Persistence will be assessed in terms of therapeutic continuity from the start of treatment to enrollment.'}], 'secondaryOutcomes': [{'measure': 'Description of safety of treatment with Bempedoic acid in a real-life Italian population', 'timeFrame': '6-12-24-36 months', 'description': 'Safety will be evaluated in terms of adverse reactions or intolerance to the drug.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypercholesterolemia']}, 'descriptionModule': {'briefSummary': 'Evaluation of adherence, persistence, and efficacy of treatment with Bempedoic acid in a real-life Italian population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population includes patients from Italy who have received Bempedoic acid as part of routine clinical management of their hyperlipidaemia, based on national reimbursement criteria at the time of enrollment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients under Bempedoic acid treatment\n\nExclusion Criteria:\n\n* Age \\< 18 years o \\> 80 years\n* Patients who refuse to participate and to sign informed consent'}, 'identificationModule': {'nctId': 'NCT07374861', 'acronym': 'BEMPENET', 'briefTitle': 'Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Bempedoic Acid in Italy', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Bempedoic Acid in Italy', 'orgStudyIdInfo': {'id': 'Prot. 28/2025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects with hyperlipidaemia under Bempedoic acid treatment', 'interventionNames': ['Drug: Bempedoic acid']}], 'interventions': [{'name': 'Bempedoic acid', 'type': 'DRUG', 'description': 'film-coated tablets', 'armGroupLabels': ['Subjects with hyperlipidaemia under Bempedoic acid treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Naples', 'state': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Pasquale Perrone Filardi', 'role': 'CONTACT', 'email': 'fpperron@unina.it', 'phone': '+39081/7462224'}], 'facility': 'Federico II University of Naples, Department of Advanced Biomedical Sciences', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}], 'centralContacts': [{'name': 'Pasquale Perrone Filardi', 'role': 'CONTACT', 'email': 'fpperron@unina.it', 'phone': '+39081/7462224'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pasquale Perrone Filardi', 'investigatorAffiliation': 'Federico II University'}}}}