Observing prescription patterns and effects of STAFEN Cap in 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
This study looks at how well STAFEN capsules work for Korean patients with mixed dyslipidemia and checks for any side effects related to muscle pain while they take the medication.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4000 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Hanlim Pharm. Co., Ltd. Industry-sponsored |
| Locations | 1 site (Gangneung-si) |
| Trial ID | NCT06204380 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on Korean patients diagnosed with mixed dyslipidemia who have been prescribed STAFEN capsules. It aims to monitor changes in blood lipid concentrations and assess the safety of the treatment, particularly regarding statin-related muscle symptoms. The study will analyze prescription patterns and the overall effectiveness of STAFEN under real-world clinical conditions. Participants will be observed over time to gather data on their health outcomes related to the medication.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 19 years old who have been diagnosed with mixed dyslipidemia and are starting treatment with STAFEN capsules.
Not a fit: Patients who are pregnant, lactating, or planning to conceive will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness and safety of STAFEN capsules for managing mixed dyslipidemia.
How similar studies have performed: While this study focuses on a specific medication and population, similar observational studies have shown success in identifying prescription patterns and treatment outcomes in dyslipidemia management.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Gangneung-si
- Delphoe Clinic — Gangneung-si, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Heebaek Park — delphoe clinic
- Study coordinator: Heebaek Park
- Email: thyroid62@hanmail.net
- Phone: 01055279616
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.