Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2025-12-31 @ 8:19 AM
Study NCT ID:
NCT05870657
Status:
COMPLETED
Last Update Posted:
2023-05-23
First Post:
2023-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adherence and Persistence to Inclisiran Among Early Users in Germany
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1109}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-12', 'studyFirstSubmitDate': '2023-05-12', 'studyFirstSubmitQcDate': '2023-05-12', 'lastUpdatePostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number and percentage of patients with at least 5 months of potential follow-up who were prescribed a second dose of inclisiran', 'timeFrame': '8 months'}, {'measure': 'Percentage of patients who were prescribed a second dose of inclisiran between 1 and 6 months after prescription of first dose', 'timeFrame': '8 months'}, {'measure': 'Median time between first and second prescribed doses', 'timeFrame': '8 months'}], 'secondaryOutcomes': [{'measure': 'Age and gender characteristics', 'timeFrame': '6 months'}, {'measure': 'Age and gender distribution', 'timeFrame': '6 months'}, {'measure': 'Prescriber specialty distribution for patients', 'timeFrame': '6 months'}]}, 'conditionsModule': {'conditions': ['High Levels of Low-density Lipoprotein Cholesterol']}, 'descriptionModule': {'briefSummary': 'The present study was a descriptive, non-interventional, retrospective cohort study aimed at evaluating early data on adherence, persistence, and treatment patterns among patients receiving inclisiran and other lipid-lowering therapies (LLT) in a real-world setting in Germany. Analysis was carried out using the IQVIA™ LRx database.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This was a retrospective, noninterventional cohort study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Study subjects ≥18 years old who were prescribed an inclisiran dose.\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT05870657', 'briefTitle': 'Adherence and Persistence to Inclisiran Among Early Users in Germany', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Adherence and Persistence to Inclisiran Among Early Users in Germany', 'orgStudyIdInfo': {'id': 'CKJX839A12013'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Overall cohort', 'description': 'Patients receiving inclisiran'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Basel', 'country': 'Switzerland', 'facility': 'Novartis', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}