Statin Monotherapy and Rosuzet Tab.(Rosuvastatin/Ezetimibe) Administration in Patients With Dyslipidemia in Korea

Completed

• Conditions: Dyslipidemias

• Registration Number: NCT04829149
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

A Cohort Study for Comparison of Statin Monotherapy and Rosuzet Tab.(Rosuvastatin/Ezetimibe) Administration and Statin Prescription Patterns in Patients With Dyslipidemia in Korea.

Detailed Description

The main objective of this study is to evaluate the effect of reducing LDL-C levels after 12 months of administration of Statin Monotherapy or Rosuzet Tab.(Rosuvastatin/Ezetimibe) in patients with dyslipidemia in Korea

Study Timeline

• Study Start: 2016-06-14
• Primary Completion: 2019-06-01
• Study Completion: 2019-08-29
• Study First Submitted: 2021-03-22
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-01
• Last Update Submitted: 2021-04-01
• Study First Posted: 2021-04-02
• Last Update Posted: 2021-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5717

Inclusion Criteria

1. Age≥19
2. Subject who is taking or is scheduled to take Statins therapy or Rosuzet Tab.
3. Not diagnosed with diabetes
4. Subject who can written informed consent voluntarily
5. Subject can continue to participate for 12 months on Study

Exclusion Criteria

1. Patients for whom use of Rosuzet Tab. and Statin therapy is prohibited (e.g. patient who are hypersensitive to the main or compositional component of this drug, patient with active liver disease, patient with severe renal failure, patient using combinations with cyclosporin)
2. A pregnant or nursing woman

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lipid profiles	12 months	LDL-C percentage of change in Statin therapy group and Rosuzet group from baseline

Secondary Outcome Measures

Name	Time	Method
Prescription rate	12 months	Prescription rate of Statin therapy group and Rosuzet group during the study period
Medication compliance	12 months	MPR(medication possession ratio) of Statin therapy group and Rosuzet group during the study period
Occurrence and aspect of new onset diabetes and adverse events	12 months	Occurrence and aspect of new onset diabetes and adverse events in Statin therapy group and Rosuzet group during the study period
Reason for medication change	12 months	Evaluation of Rate on reason for medication change in Statin therapy group and Rosuzet group during the study period
Lipid profiles	6, 12 months	Triglyceride, HDL-C, Total Cholesterol percentage of change in Statin therapy group and Rosuzet group from baseline

Trial Locations

Locations (1)

Hanmi Pharmaceutical Company Limited; 🇰🇷 Seoul, Korea, Republic of