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

Dyslipidemias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04829149
• Other study ID #: HM-ROZ-OS-01
• Status: Completed
• Start date: June 14, 2016
• Est. completion date: August 29, 2019

Study information

• Verified date: April 2021
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5717
• Est. completion date: August 29, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

Other:
• Observational
Statin therapy group and Rosuzet tablet group

Locations

Country	Name	City	State
Korea, Republic of	Hanmi Pharmaceutical Company Limited	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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