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

Hanmi Pharmaceutical

Status: Completed

Conditions: Dyslipidemias

Treatments: Other: Observational

Study type: Observational

Funder types: Industry

Identifiers

NCT04829149

HM-ROZ-OS-01

Details and patient eligibility

About

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

Full 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

Enrollment: 5,717 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

5,717 participants in 2 patient groups

Statin therapy group (No interventional)

Description:

Observational. Statin therapy group: Once daily administered per the locally approved product information of rosuvastatin, simvastatin, atorvastatin, pitavastatin etc,. (except Rosuzet Tab.)

Treatment:

Other: Observational

Rosuzet tablet group (No interventional)

Description:

Observational. Rosuzet Tab.(ezetimibe/rosuvastatin) group: once daily administered per the locally approved product information of Rosuzet Tab. 10/5mg, 10/10mg, 10/20mg

Treatment:

Other: Observational