An Observational Study on the Identification of Prescription Patterns of STAFEN Cap

NCT ID: NCT06204380

Last Updated: 2024-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-21

Study Completion Date

2024-11-30

Brief Summary

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An observational study on the identification of prescription patterns of STAFEN Cap., changes in blood lipid concentration, and statin-related muscle symptoms in Korean patients with mixed dyslipidemia

Detailed Description

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This study aims to observe the effectiveness of STAFEN capsule such as changes in blood lipid concentration and safety including statin-related muscle symptoms, and prescription patterns under daily clinical treatment in patients who have been prescribed STAFEN capsules for the treatment of complex dyslipidemia.

Conditions

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Mixed Dyslipidemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Adults over 19 years of age
2. A patient diagnosed with mixed dyslipidemia
3. A patient who was first prescribed a STAFEN cap. for the purpose of treating mixed dyslipidemia according to the clinician's judgment
4. A patient who voluntarily agreed in writing to this study

Exclusion Criteria

1. Pregnant women, lactating women, or those planning to conceive
2. A person who is prohibited from administering the STAFEN cap. under the permit
3. If the person in charge of other clinical studies and the person in charge deems it inappropriate to be the subject of this clinical study
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hanlim Pharm. Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heebaek Park

Role: PRINCIPAL_INVESTIGATOR

delphoe clinic

Locations

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Delphoe Clinic

Gangneung-si, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Heebaek Park

Role: CONTACT

01055279616

Facility Contacts

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Heebaek NA Park

Role: primary

01055279616

Other Identifiers

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HL-STAF-401

Identifier Type: -

Identifier Source: org_study_id

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