An Observational Study on the Identification of Prescript... | NCT06204380

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

NCT06204380

Sponsor

Hanlim Pharm. Co., Ltd.

Status

Unknown status

Last Update Posted

Jan 17, 2024Actual

Enrollment

4,000Estimated

Phase

Not provided

Conditions

Mixed Dyslipidemia

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 21, 2021Actual

Primary Completion Date

Nov 30, 2024Estimated

Completion Date

Nov 30, 2024Estimated

First Submitted Date

Jan 3, 2024

First Submission Date that Met QC Criteria

Jan 11, 2024

First Posted Date

Jan 12, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2024

Last Update Posted Date

Jan 17, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,000Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients Prescribed STAFEN Cap. for the Treatment of Mixed Dyslipidemia

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Heebaek Park	Contact	01055279616		thyroid62@hanmail.net

Overall Officials

Name	Affiliation	Role
Heebaek Park	delphoe clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Delphoe Clinic	Recruiting	Gangneung-si			South Korea