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

• Sponsor: Hanmi Pharmaceutical Company Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04829149
• Collaborator: (none)
• Enrollment: 5,717
• Location: 1
• Actual Duration (Months): 38.5
• Patients Per Site Per Month: 148.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemias	Other: Observational

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 Design

• Study Type: Observational
• Actual Enrollment: 5717 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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.
• Actual Study Start Date: Jun 14, 2016
• Actual Primary Completion Date: Jun 1, 2019
• Actual Study Completion Date: Aug 29, 2019

Arms and Interventions

Arm	Intervention/Treatment
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; Statin therapy group and Rosuzet tablet group
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; Statin therapy group and Rosuzet tablet group

Outcome Measures

Primary Outcome Measures

1. Lipid profiles [12 months]

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

Secondary Outcome Measures

1. Lipid profiles [6 months]

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

2. Lipid profiles [6, 12 months]

   Triglyceride, HDL-C, Total Cholesterol percentage of change in Statin therapy group and Rosuzet group from baseline

3. 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

4. Prescription rate [12 months]

   Prescription rate of Statin therapy group and Rosuzet group during the study period

5. 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

6. Medication compliance [12 months]

   MPR(medication possession ratio) of Statin therapy group and Rosuzet group during the study period

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hanmi Pharmaceutical Company Limited	Seoul		Korea, Republic of	05545

Sponsors and Collaborators

• Hanmi Pharmaceutical Company Limited

Investigators

• Study Director: Mi-Jeung KIM, Hanmi Pharmaceutical Company Limited

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hanmi Pharmaceutical Company Limited
• ClinicalTrials.gov Identifier: NCT04829149
• Other Study ID Numbers: HM-ROZ-OS-01
• First Posted: Apr 2, 2021
• Last Update Posted: Apr 2, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hanmi Pharmaceutical Company Limited: Statin; Rosuvastatin; New onset DM; LDL-C
• Additional relevant MeSH terms: Dyslipidemias

Study Results

No Results Posted as of Apr 2, 2021