DyslipidemiaNCT05120895

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

An observational study of Dyslipidemia, run by Daiichi Sankyo at 58 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Dyslipidemia
What is being tested?: Mevalotin
Type of treatment: Pill or oral medicine
How many people: 3,060 participants
Where: 58 sitesSouth Korea
Study dates: 10 Aug 2021to 27 Dec 2024
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

58 sites in 1 country.

City, postcode or hospital

58 sites in 1 country

South Korea58 sites

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

Other trials in South Korea

About this study

Official title: 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

Read the 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.

Conditions: Dyslipidemia
Being tested: Mevalotin
Keywords: Dyslipidemia, Mevalotin®, Menopause, Blood cholesterol
Medical subject headings: Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MevalotinDrug
Oral tablets (starting dose 5 mg)

Study groups in NCT05120895
Study group	Role	What they receive
Mevalotin		Korean menopausal women aged 50 years or more who required treatment of dyslipidemia and received Mevalotin® tablets. Receives: Drug: Mevalotin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Aug 202127 Dec 2024

First posted15 Nov 2021
Study start10 Aug 2021
Primary completion2 Sep 2024
Study completion27 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for DyslipidemiaStudies of the same condition, open and under way.
More trials run by Daiichi SankyoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 3,060 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05120895
Sponsor's protocol ID: MVT-OS-21-01
Status last verified: Jul 2025
First submitted: 2 Nov 2021
Last updated: 23 Jul 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease

All Dyslipidemia trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05120895
Acronym / sponsor ID: MVT-OS-21-01
Conditions: Dyslipidemia
Keywords: Dyslipidemia, Mevalotin®, Menopause, Blood cholesterol
Study type: Observational
Recruitment status: Completed
Enrolment: 3,060 participants (actual)
Lead sponsor: Daiichi SankyoIndustry (pharma, biotech, devices)
Collaborators: Daiichi Sankyo Korea Co., Ltd.
Study start: 10 Aug 2021 (actual)
Primary completion: 2 Sep 2024 (actual)
Study completion: 27 Dec 2024 (actual)
First posted: 15 Nov 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Mevalotin	–	Drug: MevalotinKorean menopausal women aged 50 years or more who required treatment of dyslipidemia and received Mevalotin® tablets.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (4 listed)

Menopausal women aged 50 years or more diagnosed with dyslipidemia
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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MevalotinOral tablets (starting dose 5 mg)	Drug	Mevalotin

Primary outcome

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.

5 secondary outcomes

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
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
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
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
Number of participants with treatment-emergent adverse events after Mevalotin® Tablet administration
Time frame: Week 48 post-dose

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
Individual participant dataSharing planned: No

Related trials for Dyslipidemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Leader study director

Daiichi Sankyo

58 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Dyslipidemia, run by Daiichi Sankyo at 58 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in low-density lipoprotein cholesterol at Week 24 after Mevalotin® Tablet administration (time frame: Week 24 post-dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05120895.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.