Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2025-12-27 @ 9:53 PM
Study NCT ID:
NCT05120895
Status:
COMPLETED
Last Update Posted:
2025-07-23
First Post:
2021-11-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study Investigating the Change in Blood Cholesterol With Mevalotin® Tablet Administration in Korean Menopausal Women Aged 50 Years or More Who Require Treatment of Dyslipidemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017035', 'term': 'Pravastatin'}], 'ancestors': [{'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3060}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-18', 'studyFirstSubmitDate': '2021-11-02', 'studyFirstSubmitQcDate': '2021-11-02', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in low-density lipoprotein cholesterol at Week 24 after Mevalotin® Tablet administration', 'timeFrame': 'Week 24 post-dose', 'description': 'The change from baseline (mg/dL) in low-density lipoprotein cholesterol (LDL-C) will be assessed at Week 24 from blood plasma samples.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in total cholesterol, triglyceride, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol at Week 24 after Mevalotin® Tablet administration', 'timeFrame': 'Week 24 post-dose', 'description': 'The change from baseline (mg/dL) in total cholesterol, triglyceride, high-density lipoprotein, and non-high-density lipoprotein cholesterol will be assessed at Week 24 from blood plasma samples.'}, {'measure': 'Percent change from baseline in low-density lipoprotein, total cholesterol, triglyceride, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol at Week 24 after Mevalotin® Tablet administration', 'timeFrame': 'Week 24 post-dose', 'description': 'The percent change from baseline (%) in low-density lipoprotein, total cholesterol, triglyceride, high-density lipoprotein, and non-high-density lipoprotein cholesterol will be assessed at Week 24 from blood plasma samples.'}, {'measure': 'Change from baseline in low-density lipoprotein, total cholesterol, triglyceride, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol at Week 48 after Mevalotin® Tablet administration', 'timeFrame': 'Week 48 post-dose', 'description': 'The change from baseline (mg/dL) in total cholesterol, triglyceride, high-density lipoprotein, and non-high-density lipoprotein cholesterol will be assessed at Week 48 from blood plasma samples.'}, {'measure': 'Percent change from baseline in low-density lipoprotein, total cholesterol, triglyceride, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol at Week 48 after Mevalotin® Tablet administration', 'timeFrame': 'Week 48 post-dose', 'description': 'The percent change from baseline (%) in low-density lipoprotein, total cholesterol, triglyceride, high-density lipoprotein, and non-high-density lipoprotein cholesterol will be assessed at Week 48 from blood plasma samples.'}, {'measure': 'Number of participants with treatment-emergent adverse events after Mevalotin® Tablet administration', 'timeFrame': 'Week 48 post-dose', 'description': 'Treatment-emergent adverse event (TEAE) is defined as an event that emerges during treatment, having been absent pretreatment, or worsens relative to the pretreatment state.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dyslipidemia', 'Mevalotin®', 'Menopause', 'Blood cholesterol'], 'conditions': ['Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'This study will investigate the efficacy and safety based on the observation of the blood cholesterol change with Mevalotin® Tablet administration in Korean menopausal women aged 50 years or more who require treatment of dyslipidemia.', 'detailedDescription': 'In this prospective, observational study, patient data (eg, clinical outcomes in actual clinical settings, demographic information, medical treatment-related information, Mevalotin® Tablet administration start date \\[Index date\\], and the lipid profile results at Week 24 after Mevalotin® Tablet administration start date) will be collected from medical records. No study drug will be administered in this study.\n\nPatient data will be used to determine the change in blood cholesterol with Mevalotin® Tablet administration (5 mg, 10 mg, 20 mg, 40 mg as determined by Investigator in clinical practice) in Korean menopausal women aged 50 years or more who require treatment of dyslipidemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include Korean menopausal women aged 50 years or more who are prescribed with Mevalotin® Tablet at the medical discretion of an investigator as part of routine medical practice.', 'genderDescription': 'Only Korean women are eligible for this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Menopausal women aged 50 years or more diagnosed with dyslipidemia\n\n * Menopause was defined as the condition of not having menstruation for 1 year with no specific cause or being diagnosed with menopause at the discretion of an investigator (except for the case of being diagnosed with menopause for a surgical reason within 5 years), and the menopausal status is confirmed as of the Mevalotin® Tablet administration start date (Index date).\n* Patients who are determined to be prescribed with Mevalotin® Tablet at the discretion of an investigator or patients who started Mevalotin® Tablet administration within 6 weeks prior to enrollment in this observational study (however, in case of patients switching from statins to Mevalotin® Tablet, only those who receive from low/intermediate intensity statins treatment to low/intermediate intensity statins treatment can be enrolled in this study)\n* Patients who provided voluntary written consent to take part in this observational study\n\nExclusion Criteria:\n\n* Patients with a history of cancer within 5 years (however, patients with a history of brain tumor, breast cancer, uterine cancer, ovarian cancer, or endometrial cancer are excluded from enrollment regardless of duration.)\n* Patients who received hormone replacement therapy within 1 year of enrollment\n* Patients who are determined to be ineligible for participation in this observational study'}, 'identificationModule': {'nctId': 'NCT05120895', 'briefTitle': 'An Observational Study Investigating the Change in Blood Cholesterol With Mevalotin® Tablet Administration in Korean Menopausal Women Aged 50 Years or More Who Require Treatment of Dyslipidemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'A Multicenter, Prospective, Non-interventional Observational Study to Investigate the Change in Blood Cholesterol With Mevalotin® Tablet Administration in Korean Menopausal Women Aged 50 Years or More Who Require Treatment of Dyslipidemia', 'orgStudyIdInfo': {'id': 'MVT-OS-21-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mevalotin', 'description': 'Korean menopausal women aged 50 years or more who required treatment of dyslipidemia and received Mevalotin® tablets.', 'interventionNames': ['Drug: Mevalotin']}], 'interventions': [{'name': 'Mevalotin', 'type': 'DRUG', 'description': 'Oral tablets (starting dose 5 mg)', 'armGroupLabels': ['Mevalotin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14584', 'city': 'Bucheon-si', 'country': 'South Korea', 'facility': 'Soon Chun Hyang University Hospital Bucheon', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'zip': '14754', 'city': 'Bucheon-si', 'country': 'South Korea', 'facility': 'Bucheon Sejong Hospital', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'zip': '47392', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Inje University Busan Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '48108', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Inje University Haeundae Paik Hospital - Site 0011', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '48108', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Inje University Haeundae Paik Hospital - Site 0031', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '48775', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Boneseng Memorial Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '49241', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Pusan National University Hospital - Site 0013', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '49241', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Pusan National University Hospital - Site 0033', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '28644', 'city': 'Cheongju-si', 'country': 'South Korea', 'facility': 'Chungbuk National University Hospital', 'geoPoint': {'lat': 36.63722, 'lon': 127.48972}}, {'zip': '24253', 'city': 'Chuncheon', 'country': 'South Korea', 'facility': 'Hallym University Medical Center - Chuncheon', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}, {'zip': '24289', 'city': 'Chuncheon', 'country': 'South Korea', 'facility': 'Kangwon National University Hospital - Site 0050', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}, {'zip': '24289', 'city': 'Chuncheon', 'country': 'South Korea', 'facility': 'Kangwon National University Hospital', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}, {'zip': '41931', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Keimyung University Dongsan Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '35233', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Eulji University Hospital - Site 0004', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '35233', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Eulji University Hospital - Site 0040', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '35365', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Konyang University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '10380', 'city': 'Goyang-si', 'country': 'South Korea', 'facility': 'Inje University Ilsan Paik Hospital', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'zip': '10475', 'city': 'Goyang-si', 'country': 'South Korea', 'facility': 'Myongji Hospital', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'zip': '11923', 'city': 'Guri-si', 'country': 'South Korea', 'facility': 'Hanyang University Guri Hospital - Site 0022', 'geoPoint': {'lat': 37.5986, 'lon': 127.1394}}, {'zip': '11923', 'city': 'Guri-si', 'country': 'South Korea', 'facility': 'Hanyang University Guri Hospital - Site 0044', 'geoPoint': {'lat': 37.5986, 'lon': 127.1394}}, {'zip': '11923', 'city': 'Guri-si', 'country': 'South Korea', 'facility': 'Hanyang University Guri Hospital - Site 0049', 'geoPoint': {'lat': 37.5986, 'lon': 127.1394}}, {'zip': '58128', 'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Chonnam National University Hospital Hwasun Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '61453', 'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Chosun University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '21431', 'city': 'Incheon', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Incheon St. Mary's Hospital", 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '21565', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Gachon University Gil Medical Center', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '22332', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Inha University Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '52727', 'city': 'Jinju', 'country': 'South Korea', 'facility': 'Gyeongsang National University Hospital', 'geoPoint': {'lat': 35.19278, 'lon': 128.08472}}, {'zip': '37661', 'city': 'Pohang', 'country': 'South Korea', 'facility': "Pohang St. Mary's Hospital", 'geoPoint': {'lat': 36.02917, 'lon': 129.36481}}, {'zip': '37816', 'city': 'Pohang', 'country': 'South Korea', 'facility': 'SM Christianity Hospital', 'geoPoint': {'lat': 36.02917, 'lon': 129.36481}}, {'zip': '13590', 'city': 'Seongnam-si', 'country': 'South Korea', 'facility': 'Bundang Jesaeng Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '13620', 'city': 'Seongnam-si', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital - Site 0001', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '13620', 'city': 'Seongnam-si', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital - Site 0019', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '02841', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03181', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kangbuk Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03312', 'city': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Eunpyeong St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Yonsei University Health System, Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '04401', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Soon Chun Hyang University Hospital Seoul', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '04763', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hanyang University Seoul Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05278', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyung Hee University Hospital at Gangdong', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05368', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'VHS Medical Center - Site 0020', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05368', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'VHS Medical Center - Site 0039', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06591', 'city': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Seoul St. Mary's Hospital - Site 0018", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06591', 'city': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Seoul St. Mary's Hospital - Site 0024", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06591', 'city': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Seoul St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06973', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Chung-Ang University Gwangmyeong Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '07345', 'city': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Yeouido St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '07441', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hallym University Medical Center-Kangnam', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '16247', 'city': 'Suwon', 'country': 'South Korea', 'facility': "The Catholic University of Korea, St. Vincent's Hospital", 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'zip': '16500', 'city': 'Suwon', 'country': 'South Korea', 'facility': 'Ajou University Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'zip': '11759', 'city': 'Uijeongbu-si', 'country': 'South Korea', 'facility': 'Uijeongbu Eulji Medical Center, Eulji University - Site 0053', 'geoPoint': {'lat': 37.7415, 'lon': 127.0474}}, {'zip': '11759', 'city': 'Uijeongbu-si', 'country': 'South Korea', 'facility': 'Uijeongbu Eulji Medical Center, Eulji University', 'geoPoint': {'lat': 37.7415, 'lon': 127.0474}}, {'zip': '11765', 'city': 'Uijeongbu-si', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Uijeongbu St. Mary's Hospital", 'geoPoint': {'lat': 37.7415, 'lon': 127.0474}}, {'zip': '44033', 'city': 'Ulsan', 'country': 'South Korea', 'facility': 'Ulsan Univeristy Hospital', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}, {'zip': '26426', 'city': 'Wŏnju', 'country': 'South Korea', 'facility': 'Yonsei University, Wonju Severance Christian Hospital - Site 0051', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}, {'zip': '26426', 'city': 'Wŏnju', 'country': 'South Korea', 'facility': 'Yonsei University, Wonju Severance Christian Hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}, {'zip': '50612', 'city': 'Yangsan', 'country': 'South Korea', 'facility': 'Pusan National University Yangsan Hospital', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}, {'zip': '16995', 'city': 'Yŏngin', 'country': 'South Korea', 'facility': 'Yonsei University Yongin Severance Hospital', 'geoPoint': {'lat': 36.8553, 'lon': 126.9537}}], 'overallOfficials': [{'name': 'Global Clinical Leader', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Daiichi Sankyo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daiichi Sankyo', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Daiichi Sankyo Korea Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}