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: Daiichi Sankyo, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05120895
• Collaborator: Daiichi Sankyo Korea Co., Ltd. (Industry)
• Enrollment: 1,237
• Locations: 56
• Anticipated Duration (Months): 19.7
• Patients Per Site: 22.1
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemia	Drug: Mevalotin

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 Design

• Study Type: Observational
• Anticipated Enrollment: 1237 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Aug 10, 2021
• Anticipated Primary Completion Date: Apr 1, 2023
• Anticipated Study Completion Date: Apr 1, 2023

Arms and Interventions

Arm	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)

Outcome Measures

Primary Outcome Measures

1. Change from baseline in low-density lipoprotein cholesterol at Week 24 after Mevalotin® Tablet administration [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.

Secondary Outcome Measures

1. Change from baseline in total cholesterol, triglyceride, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol at Week 24 after Mevalotin® Tablet administration [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.

2. 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 [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.

3. 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 [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.

4. 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 [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.

5. Number of participants with treatment-emergent adverse events after Mevalotin® Tablet administration [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Soon Chun Hyang University Hospital Bucheon	Bucheon-si		Korea, Republic of	14584
2	Bucheon Sejong Hospital	Bucheon		Korea, Republic of	14754
3	Inje University Busan Paik Hospital	Busan		Korea, Republic of	47392
4	Inje University Haeundae Paik Hospital - Site 0011	Busan		Korea, Republic of	48108
5	Inje University Haeundae Paik Hospital - Site 0031	Busan		Korea, Republic of	48108
6	Pusan National University Hospital - Site 0013	Busan		Korea, Republic of	49241
7	Pusan National University Hospital - Site 0033	Busan		Korea, Republic of	49241
8	Chungbuk National University Hospital	Cheongju-si		Korea, Republic of	28644
9	Hallym University Medical Center - Chuncheon	Chuncheon		Korea, Republic of	24253
10	Kangwon National University Hospital - Site 0050	Chuncheon		Korea, Republic of	24289
11	Kangwon National University Hospital	Chuncheon		Korea, Republic of	24289
12	Keimyung University Dongsan Hospital	Daegu		Korea, Republic of	41931
13	Eulji University Hospital - Site 0004	Daejeon		Korea, Republic of	35233
14	Eulji University Hospital - Site 0040	Daejeon		Korea, Republic of	35233
15	Inje University Ilsan Paik Hospital	Goyang-si		Korea, Republic of	10380
16	Myongji Hospital	Goyang-si		Korea, Republic of	10475
17	Hanyang University Guri Hospital - Site 0022	Guri		Korea, Republic of	11923
18	Hanyang University Guri Hospital - Site 0044	Guri		Korea, Republic of	11923
19	Hanyang University Guri Hospital - Site 0049	Guri		Korea, Republic of	11923
20	Chonnam National University Hospital Hwasun Hospital	Gwangju		Korea, Republic of	58128
21	Chosun University Hospital	Gwangju		Korea, Republic of	61453
22	The Catholic University of Korea, Incheon St. Mary's Hospital	Incheon		Korea, Republic of	21431
23	Gachon University Gil Medical Center	Incheon		Korea, Republic of	21565
24	Inha University Hospital	Incheon		Korea, Republic of	22332
25	Gyeongsang National University Hospital	Jinju		Korea, Republic of	52727
26	Pohang St. Mary's Hospital	Pohang		Korea, Republic of	37661
27	Bundang Jesaeng Hospital	Seongnam-si		Korea, Republic of	13590
28	Seoul National University Bundang Hospital - Site 0001	Seongnam-si		Korea, Republic of	13620
29	Seoul National University Bundang Hospital - Site 0019	Seongnam-si		Korea, Republic of	13620
30	Korea University Anam Hospital	Seoul		Korea, Republic of	02841
31	Seoul National University Hospital	Seoul		Korea, Republic of	03080
32	Kangbuk Samsung Medical Center	Seoul		Korea, Republic of	03181
33	The Catholic University of Korea, Eunpyeong St. Mary's Hospital	Seoul		Korea, Republic of	03312
34	Yonsei University Health System, Severance Hospital	Seoul		Korea, Republic of	03722
35	Soon Chun Hyang University Hospital Seoul	Seoul		Korea, Republic of	04401
36	Hanyang University Seoul Hospital	Seoul		Korea, Republic of	04763
37	Kyung Hee University Hospital at Gangdong	Seoul		Korea, Republic of	05278
38	VHS Medical Center - Site 0020	Seoul		Korea, Republic of	05368
39	VHS Medical Center - Site 0039	Seoul		Korea, Republic of	05368
40	The Catholic University of Korea, Seoul St. Mary's Hospital - Site 0018	Seoul		Korea, Republic of	06591
41	The Catholic University of Korea, Seoul St. Mary's Hospital - Site 0024	Seoul		Korea, Republic of	06591
42	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul		Korea, Republic of	06591
43	Chung-Ang University Gwangmyeong Hospital	Seoul		Korea, Republic of	06973
44	The Catholic University of Korea, Yeouido St. Mary's Hospital	Seoul		Korea, Republic of	07345
45	Hallym University Medical Center-Kangnam	Seoul		Korea, Republic of	07441
46	Ajou University Hospital	Suwon-si		Korea, Republic of	16500
47	The Catholic University of Korea, St. Vincent's Hospital	Suwon		Korea, Republic of	16247
48	Ajou University Hospital	Suwon		Korea, Republic of	16500
49	Uijeongbu Eulji Medical Center, Eulji University - Site 0053	Uijeongbu		Korea, Republic of	11759
50	Uijeongbu Eulji Medical Center, Eulji University	Uijeongbu		Korea, Republic of	11759
51	The Catholic University of Korea, Uijeongbu St. Mary's Hospital	Uijeongbu		Korea, Republic of	11765
52	Ulsan Univeristy Hospital	Ulsan		Korea, Republic of	44033
53	Yonsei University, Wonju Severance Christian Hospital - Site 0051	Wŏnju		Korea, Republic of	26426
54	Yonsei University, Wonju Severance Christian Hospital	Wŏnju		Korea, Republic of	26426
55	Pusan National University Yangsan Hospital	Yangsan		Korea, Republic of	50612
56	Yonsei University Yongin Severance Hospital	Yongin		Korea, Republic of	16995

Sponsors and Collaborators

• Daiichi Sankyo, Inc.
• Daiichi Sankyo Korea Co., Ltd.

Investigators

• Study Director: Global Clinical Leader, Daiichi Sankyo, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daiichi Sankyo, Inc.
• ClinicalTrials.gov Identifier: NCT05120895
• Other Study ID Numbers: MVT-OS-21-01
• First Posted: Nov 15, 2021
• Last Update Posted: Jul 6, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Daiichi Sankyo, Inc.: Dyslipidemia; Mevalotin®; Menopause; Blood cholesterol
• Additional relevant MeSH terms: Dyslipidemias; Pravastatin

Study Results

No Results Posted as of Jul 6, 2022