NCT06204380

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 21, 2021

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

3.6 years

First QC Date

January 3, 2024

Last Update Submit

January 15, 2024

Conditions

Mixed Dyslipidemia

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients Prescribed STAFEN Cap. for the Treatment of Mixed Dyslipidemia

You may qualify if:

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

You may not qualify if:

  • Pregnant women, lactating women, or those planning to conceive
  • A person who is prohibited from administering the STAFEN cap. under the permit
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Delphoe Clinic

Gangneung-si, South Korea

RECRUITING

Study Officials

  • Heebaek Park

    delphoe clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heebaek Park

CONTACT

01055279616thyroid62@hanmail.net

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2024

First Posted

January 12, 2024

Study Start

April 21, 2021

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

January 17, 2024

Record last verified: 2024-01

Locations

KR(1)