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NCT06204380 Clinical Trial

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

Mixed Dyslipidemia Clinical Trial

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06204380
Other study ID # HL-STAF-401
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 21, 2021
Est. completion date November 30, 2024

Study information
Verified date January 2024
Source Hanlim Pharm. Co., Ltd.
Contact Heebaek Park
Phone 01055279616
Email thyroid62@hanmail.net
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 4000
Est. completion date November 30, 2024
Est. primary completion date November 30, 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Delphoe Clinic Gangneung-si

Sponsors (1)
Lead Sponsor Collaborator
Hanlim Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Target triglyceride rate at 6 months of STAFEN capsule prescription compared to baseline Target triglyceride rate at 6 months of STAFEN capsule prescription compared to baseline at 6 months of STAFEN capsule prescription compared to baseline
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