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

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

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

Study Overview

• Status: Recruiting
• Conditions: Mixed Dyslipidemia

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

• Study Contact: Name: Heebaek Park; Phone Number: 01055279616; Email: thyroid62@hanmail.net

Study Locations

• Korea, Republic of
  • Gangneung-si, Korea, Republic of
    • Recruiting
    • Delphoe Clinic
    • Contact: Heebaek NA Park; Phone Number: 01055279616

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients Prescribed STAFEN Cap. for the Treatment of Mixed Dyslipidemia

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hanlim Pharm. Co., Ltd.
• Investigators: Principal Investigator: Heebaek Park, Delphoe Clinic

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2021
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: January 3, 2024
• First Submitted That Met QC Criteria: January 11, 2024
• First Posted (Actual): January 12, 2024

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 15, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: HL-STAF-401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No