Trials Sponsors Conditions Drugs Pricing

Conditions

Dyslipidemia

Keywords

DyslipidemiaMevalotin®MenopauseBlood cholesterol

Outcome Measures

Primary Outcomes (1)

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

Study Arms (1)

Mevalotin

Korean menopausal women aged 50 years or more who required treatment of dyslipidemia and received Mevalotin® tablets.

Drug: Mevalotin

Interventions

MevalotinDrug

Oral tablets (starting dose 5 mg)

Mevalotin

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age50 Years+

Sexall(Gender-based eligibility)

Gender Eligibility DetailsOnly Korean women are eligible for this study.

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

You may qualify if:

Sponsors & Collaborators

Daiichi Sankyo Korea Co., Ltd.
Industrycollaborator
Daiichi Sankyo
Industrylead

Study Sites (58)

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, 14584, South Korea

Bucheon Sejong Hospital

Bucheon-si, 14754, South Korea

Inje University Busan Paik Hospital

Busan, 47392, South Korea

Inje University Haeundae Paik Hospital - Site 0011

Busan, 48108, South Korea

Inje University Haeundae Paik Hospital - Site 0031

Busan, 48108, South Korea

Boneseng Memorial Hospital

Busan, 48775, South Korea

Pusan National University Hospital - Site 0013

Busan, 49241, South Korea

MeSH Terms

Conditions

Dyslipidemias

Interventions

Pravastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

Global Clinical Leader
Daiichi Sankyo
STUDY DIRECTOR

Enrollment

3,060 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 2, 2021

First Posted

November 15, 2021

Study Start

August 10, 2021

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

Mevalotin

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (58)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

Mevalotin

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (58)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations