Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
Study NCT ID:
NCT06214832
Status:
RECRUITING
Last Update Posted:
2024-01-22
First Post:
2024-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Observation Study on the Identification of Prescription Patterns of Lodient Tab(Telmisartan/S-amlodipine)
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4000}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-17', 'studyFirstSubmitDate': '2024-01-03', 'studyFirstSubmitQcDate': '2024-01-17', 'lastUpdatePostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percentage of patients who met target systolic blood pressure (less than 140mmHg) at 6 months of prescription for Lodient Tab compared to baseline', 'timeFrame': 'at 6 months of prescription for Lodient Tab compared to baseline', 'description': 'The percentage of patients who met target systolic blood pressure (less than 140mmHg) at 6 months of prescription for Lodient Tab compared to baseline'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'This study identify prescription patterns of Lodient Tab and evaluate the changes of the hypertension symptoms (BP pressure) who are first prescribed and taking Lodient Tab.', 'detailedDescription': 'This study aims to observe changes in symptoms according to the treatment effect of hypertension for 6 months after Lodient Tab prescription.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients Prescribed Lodient Tab for Hypertension Treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults over 19 years of age\n2. A person diagnosed with hypertension\n3. A person who has been first prescribed Lodient Tab within the past 4 months as of the IRB approval date or is scheduled to be prescribed Lodient Tab\n4. A person who voluntarily agreed in writing to this study\n\nExclusion Criteria:\n\n1. Pregnant women or nursing mothers\n2. Persons subject to prohibition according to the permission of the Lodient Tab\n3. Patients who in the judgement of the investigator, were inappropriate to participate in the study'}, 'identificationModule': {'nctId': 'NCT06214832', 'briefTitle': 'An Observation Study on the Identification of Prescription Patterns of Lodient Tab(Telmisartan/S-amlodipine)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hanlim Pharm. Co., Ltd.'}, 'officialTitle': 'An Observation Study on the Identification of Prescription Patterns of Lodient Tab(Telmisartan/S-amlodipine) and the Changes of Symptoms According to the Treatment Effect of Hypertension for Korean Hypertensive Patients', 'orgStudyIdInfo': {'id': 'HL-LDNT-401'}}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Minseop Song', 'role': 'CONTACT'}], 'facility': 'Seoul song clinic', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Minseob Song', 'role': 'CONTACT', 'email': 'song2you@naver.com', 'phone': '+820222737282'}], 'overallOfficials': [{'name': 'Minseob Song', 'role': 'STUDY_CHAIR', 'affiliation': 'Seoul song clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanlim Pharm. Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}