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

Last updated: July 3, 2024
Sponsor: Daiichi Sankyo
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Dyslipidemia

Treatment

Mevalotin

Clinical Study ID

NCT05120895
MVT-OS-21-01
  • Ages > 50
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Menopausal women aged 50 years or more diagnosed with dyslipidemia

  • Menopause was defined as the condition of not having menstruation for 1 yearwith no specific cause or being diagnosed with menopause at the discretion ofan investigator (except for the case of being diagnosed with menopause for asurgical reason within 5 years), and the menopausal status is confirmed as ofthe Mevalotin® Tablet administration start date (Index date).

  • Patients who are determined to be prescribed with Mevalotin® Tablet at thediscretion of an investigator or patients who started Mevalotin® Tabletadministration within 6 weeks prior to enrollment in this observational study (however, in case of patients switching from statins to Mevalotin® Tablet, onlythose who receive from low/intermediate intensity statins treatment tolow/intermediate intensity statins treatment can be enrolled in this study)

  • Patients who provided voluntary written consent to take part in this observationalstudy

Exclusion

Exclusion Criteria:

  • Patients with a history of cancer within 5 years (however, patients with a historyof brain tumor, breast cancer, uterine cancer, ovarian cancer, or endometrial cancerare excluded from enrollment regardless of duration.)

  • Patients who received hormone replacement therapy within 1 year of enrollment

  • Patients who are determined to be ineligible for participation in this observationalstudy

Study Design

Total Participants: 3300
Treatment Group(s): 1
Primary Treatment: Mevalotin
Phase:
Study Start date:
August 10, 2021
Estimated Completion Date:
April 30, 2025

Study Description

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.

Patient 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.

Connect with a study center

  • Bucheon Sejong Hospital

    Bucheon, 14754
    Korea, Republic of

    Site Not Available

  • Soon Chun Hyang University Hospital Bucheon

    Bucheon-si, 14584
    Korea, Republic of

    Site Not Available

  • Boneseng Memorial Hospital

    Busan, 48775
    Korea, Republic of

    Site Not Available

  • Inje University Busan Paik Hospital

    Busan, 47392
    Korea, Republic of

    Site Not Available

  • Inje University Haeundae Paik Hospital - Site 0011

    Busan, 48108
    Korea, Republic of

    Site Not Available

  • Inje University Haeundae Paik Hospital - Site 0031

    Busan, 48108
    Korea, Republic of

    Site Not Available

  • Pusan National University Hospital - Site 0013

    Busan, 49241
    Korea, Republic of

    Site Not Available

  • Pusan National University Hospital - Site 0033

    Busan, 49241
    Korea, Republic of

    Site Not Available

  • Chungbuk National University Hospital

    Cheongju-si, 28644
    Korea, Republic of

    Site Not Available

  • Hallym University Medical Center - Chuncheon

    Chuncheon, 24253
    Korea, Republic of

    Site Not Available

  • Kangwon National University Hospital

    Chuncheon, 24289
    Korea, Republic of

    Site Not Available

  • Kangwon National University Hospital - Site 0050

    Chuncheon, 24289
    Korea, Republic of

    Site Not Available

  • Keimyung University Dongsan Hospital

    Daegu, 41931
    Korea, Republic of

    Site Not Available

  • Eulji University Hospital - Site 0004

    Daejeon, 35233
    Korea, Republic of

    Site Not Available

  • Eulji University Hospital - Site 0040

    Daejeon, 35233
    Korea, Republic of

    Site Not Available

  • Konyang University Hospital

    Daejeon, 35365
    Korea, Republic of

    Site Not Available

  • Inje University Ilsan Paik Hospital

    Goyang-si, 10380
    Korea, Republic of

    Site Not Available

  • Myongji Hospital

    Goyang-si, 10475
    Korea, Republic of

    Site Not Available

  • Hanyang University Guri Hospital - Site 0022

    Guri, 11923
    Korea, Republic of

    Site Not Available

  • Hanyang University Guri Hospital - Site 0044

    Guri, 11923
    Korea, Republic of

    Site Not Available

  • Hanyang University Guri Hospital - Site 0049

    Guri, 11923
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hospital Hwasun Hospital

    Gwangju, 58128
    Korea, Republic of

    Site Not Available

  • Chosun University Hospital

    Gwangju, 61453
    Korea, Republic of

    Site Not Available

  • Gachon University Gil Medical Center

    Incheon, 21565
    Korea, Republic of

    Site Not Available

  • Inha University Hospital

    Incheon, 22332
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Incheon St. Mary's Hospital

    Incheon, 21431
    Korea, Republic of

    Site Not Available

  • Gyeongsang National University Hospital

    Jinju, 52727
    Korea, Republic of

    Site Not Available

  • Pohang St. Mary's Hospital

    Pohang, 37661
    Korea, Republic of

    Site Not Available

  • SM Christianity Hospital

    Pohang, 37816
    Korea, Republic of

    Site Not Available

  • Bundang Jesaeng Hospital

    Seongnam-si, 13590
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital - Site 0001

    Seongnam-si, 13620
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital - Site 0019

    Seongnam-si, 13620
    Korea, Republic of

    Site Not Available

  • Chung-Ang University Gwangmyeong Hospital

    Seoul, 06973
    Korea, Republic of

    Site Not Available

  • Hallym University Medical Center-Kangnam

    Seoul, 07441
    Korea, Republic of

    Site Not Available

  • Hanyang University Seoul Hospital

    Seoul, 04763
    Korea, Republic of

    Site Not Available

  • Kangbuk Samsung Medical Center

    Seoul, 03181
    Korea, Republic of

    Site Not Available

  • Korea University Anam Hospital

    Seoul, 02841
    Korea, Republic of

    Site Not Available

  • Kyung Hee University Hospital at Gangdong

    Seoul, 05278
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Soon Chun Hyang University Hospital Seoul

    Seoul, 04401
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital

    Seoul, 03312
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Seoul St. Mary's Hospital - Site 0018

    Seoul, 06591
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Seoul St. Mary's Hospital - Site 0024

    Seoul, 06591
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Yeouido St. Mary's Hospital

    Seoul, 07345
    Korea, Republic of

    Site Not Available

  • VHS Medical Center - Site 0020

    Seoul, 05368
    Korea, Republic of

    Site Not Available

  • VHS Medical Center - Site 0039

    Seoul, 05368
    Korea, Republic of

    Site Not Available

  • Yonsei University Health System, Severance Hospital

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • Ajou University Hospital

    Suwon, 16500
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon, 16247
    Korea, Republic of

    Site Not Available

  • Ajou University Hospital

    Suwon-si, 16500
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Uijeongbu St. Mary's Hospital

    Uijeongbu, 11765
    Korea, Republic of

    Site Not Available

  • Uijeongbu Eulji Medical Center, Eulji University

    Uijeongbu, 11759
    Korea, Republic of

    Site Not Available

  • Uijeongbu Eulji Medical Center, Eulji University - Site 0053

    Uijeongbu, 11759
    Korea, Republic of

    Site Not Available

  • Ulsan Univeristy Hospital

    Ulsan, 44033
    Korea, Republic of

    Site Not Available

  • Yonsei University, Wonju Severance Christian Hospital

    Wŏnju, 26426
    Korea, Republic of

    Site Not Available

  • Yonsei University, Wonju Severance Christian Hospital - Site 0051

    Wŏnju, 26426
    Korea, Republic of

    Site Not Available

  • Pusan National University Yangsan Hospital

    Yangsan, 50612
    Korea, Republic of

    Site Not Available

  • Yonsei University Yongin Severance Hospital

    Yongin, 16995
    Korea, Republic of

    Site Not Available

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