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

July 18, 2025 updated by: Daiichi Sankyo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

3060

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Bucheon, Korea, Republic of, 14754
        • Bucheon Sejong Hospital
      • Bucheon-si, Korea, Republic of, 14584
        • Soon Chun Hyang University Hospital Bucheon
      • Busan, Korea, Republic of, 47392
        • Inje University Busan Paik Hospital
      • Busan, Korea, Republic of, 48108
        • Inje University Haeundae Paik Hospital - Site 0011
      • Busan, Korea, Republic of, 48108
        • Inje University Haeundae Paik Hospital - Site 0031
      • Busan, Korea, Republic of, 48775
        • Boneseng Memorial Hospital
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital - Site 0013
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital - Site 0033
      • Cheongju-si, Korea, Republic of, 28644
        • Chungbuk National University Hospital
      • Chuncheon, Korea, Republic of, 24289
        • Kangwon National University Hospital
      • Chuncheon, Korea, Republic of, 24253
        • Hallym University Medical Center - Chuncheon
      • Chuncheon, Korea, Republic of, 24289
        • Kangwon National University Hospital - Site 0050
      • Daegu, Korea, Republic of, 41931
        • Keimyung University Dongsan Hospital
      • Daejeon, Korea, Republic of, 35365
        • Konyang University Hospital
      • Daejeon, Korea, Republic of, 35233
        • Eulji University Hospital - Site 0004
      • Daejeon, Korea, Republic of, 35233
        • Eulji University Hospital - Site 0040
      • Goyang-si, Korea, Republic of, 10380
        • Inje University Ilsan Paik Hospital
      • Goyang-si, Korea, Republic of, 10475
        • Myongji Hospital
      • Guri, Korea, Republic of, 11923
        • Hanyang University Guri Hospital - Site 0022
      • Guri, Korea, Republic of, 11923
        • Hanyang University Guri Hospital - Site 0044
      • Guri, Korea, Republic of, 11923
        • Hanyang University Guri Hospital - Site 0049
      • Gwangju, Korea, Republic of, 61453
        • Chosun university hospital
      • Gwangju, Korea, Republic of, 58128
        • Chonnam National University Hospital Hwasun Hospital
      • Incheon, Korea, Republic of, 21565
        • Gachon University Gil Medical Center
      • Incheon, Korea, Republic of, 22332
        • Inha University Hospital
      • Incheon, Korea, Republic of, 21431
        • The Catholic University of Korea, Incheon St. Mary's Hospital
      • Jinju, Korea, Republic of, 52727
        • Gyeongsang National University Hospital
      • Pohang, Korea, Republic of, 37661
        • Pohang St. Mary's Hospital
      • Pohang, Korea, Republic of, 37816
        • SM Christianity Hospital
      • Seongnam-si, Korea, Republic of, 13590
        • Bundang Jesaeng Hospital
      • Seongnam-si, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital - Site 0001
      • Seongnam-si, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital - Site 0019
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 06591
        • The Catholic University of Korea, Seoul St. Mary's Hospital
      • Seoul, Korea, Republic of, 04763
        • Hanyang University Seoul Hospital
      • Seoul, Korea, Republic of, 05278
        • Kyung Hee University Hospital at Gangdong
      • Seoul, Korea, Republic of, 03181
        • Kangbuk Samsung Medical Center
      • Seoul, Korea, Republic of, 03722
        • Yonsei University Health System, Severance Hospital
      • Seoul, Korea, Republic of, 07345
        • The Catholic University of Korea, Yeouido St. Mary's Hospital
      • Seoul, Korea, Republic of, 07441
        • Hallym University Medical Center-Kangnam
      • Seoul, Korea, Republic of, 04401
        • Soon Chun Hyang University Hospital Seoul
      • Seoul, Korea, Republic of, 03312
        • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
      • Seoul, Korea, Republic of, 05368
        • VHS Medical Center - Site 0020
      • Seoul, Korea, Republic of, 05368
        • VHS Medical Center - Site 0039
      • Seoul, Korea, Republic of, 06591
        • The Catholic University of Korea, Seoul St. Mary's Hospital - Site 0018
      • Seoul, Korea, Republic of, 06591
        • The Catholic University of Korea, Seoul St. Mary's Hospital - Site 0024
      • Seoul, Korea, Republic of, 06973
        • Chung-Ang University Gwangmyeong Hospital
      • Suwon, Korea, Republic of, 16247
        • The Catholic university of Korea, St. Vincent's Hospital
      • Suwon, Korea, Republic of, 16500
        • Ajou University Hospital
      • Suwon-si, Korea, Republic of, 16500
        • Ajou University Hospital
      • Uijeongbu, Korea, Republic of, 11759
        • Uijeongbu Eulji Medical Center, Eulji University - Site 0053
      • Uijeongbu, Korea, Republic of, 11759
        • Uijeongbu Eulji Medical Center, Eulji University
      • Uijeongbu, Korea, Republic of, 11765
        • The Catholic University of Korea, Uijeongbu St. Mary's Hospital
      • Ulsan, Korea, Republic of, 44033
        • Ulsan Univeristy Hospital
      • Wŏnju, Korea, Republic of, 26426
        • Yonsei University, Wonju Severance Christian Hospital
      • Wŏnju, Korea, Republic of, 26426
        • Yonsei University, Wonju Severance Christian Hospital - Site 0051
      • Yangsan, Korea, Republic of, 50612
        • Pusan National University Yangsan Hospital
      • Yongin, Korea, Republic of, 16995
        • Yonsei University Yongin Severance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • Menopausal women aged 50 years or more diagnosed with dyslipidemia

    • 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).
  • 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)
  • Patients who provided voluntary written consent to take part in this observational study

Exclusion Criteria:

  • 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.)
  • Patients who received hormone replacement therapy within 1 year of enrollment
  • Patients who are determined to be ineligible for participation in this observational study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mevalotin
Korean menopausal women aged 50 years or more who required treatment of dyslipidemia and received Mevalotin® tablets.
Drug: Mevalotin
Oral tablets (starting dose 5 mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in low-density lipoprotein cholesterol at Week 24 after Mevalotin® Tablet administration
Time Frame: Week 24 post-dose
The change from baseline (mg/dL) in low-density lipoprotein cholesterol (LDL-C) will be assessed at Week 24 from blood plasma samples.
Week 24 post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in total cholesterol, triglyceride, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol at Week 24 after Mevalotin® Tablet administration
Time Frame: Week 24 post-dose
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.
Week 24 post-dose
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
Time Frame: Week 24 post-dose
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.
Week 24 post-dose
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
Time Frame: Week 48 post-dose
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.
Week 48 post-dose
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
Time Frame: Week 48 post-dose
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.
Week 48 post-dose
Number of participants with treatment-emergent adverse events after Mevalotin® Tablet administration
Time Frame: Week 48 post-dose
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.
Week 48 post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo

Collaborators

Daiichi Sankyo Korea Co., Ltd.

Investigators

  • Study Director: Global Clinical Leader, Daiichi Sankyo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2021

Primary Completion (Actual)

September 2, 2024

Study Completion (Actual)

December 27, 2024

Study Registration Dates

First Submitted

November 2, 2021

First Submitted That Met QC Criteria

November 2, 2021

First Posted (Actual)

November 15, 2021

Study Record Updates

Last Update Posted (Actual)

July 23, 2025

Last Update Submitted That Met QC Criteria

July 18, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MVT-OS-21-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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