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

NCT04829149 | Completed

• 1 other identifier: HM-ROZ-OS-01
• Study Type: observational
• Target: 5,717
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyslipidemias

Keywords

Statin; Rosuvastatin; New onset DM; LDL-C

Outcome Measures

Primary Outcomes (1)

• Lipid profiles

  LDL-C percentage of change in Statin therapy group and Rosuzet group from baseline

  12 months

Secondary Outcomes (6)

• Lipid profiles

  6 months

• Lipid profiles

  6, 12 months

• Occurrence and aspect of new onset diabetes and adverse events

  12 months

• Prescription rate

  12 months

• Reason for medication change

  12 months

Study Arms (2)

Statin therapy group (No interventional)

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

Other: Observational

Rosuzet tablet group (No interventional)

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

Other: Observational

Interventions

Observational OTHER

Statin therapy group and Rosuzet tablet group

Rosuzet tablet group (No interventional); Statin therapy group (No interventional)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A Korean dyslipidemia patient who is taking or is scheduled to take statins therapy or Rosuzet tablets

You may qualify if:

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

You may not qualify if:

• 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)
• A pregnant or nursing woman

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Hanmi Pharmaceutical Company Limited

Seoul, 05545, South Korea

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Mi-Jeung KIM

  Hanmi Pharmaceutical Company Limited

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: April 2, 2021
• Study Start: June 14, 2016
• Primary Completion: June 1, 2019
• Study Completion: August 29, 2019
• Last Updated: April 2, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)