NCT05555238

An Observational Study to Evaluate the Treatment of Newvast® Tab(Atorvastatin) in Korean Patients With Dyslipidemia

An Observational Study to Evaluate the Safety and Effectiveness of Newvast Tab(Atorvastatin) in Korean Dyslipidemia Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,716 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

In this study, dyslipidemia patients visited the institutions during the study period and the effectiveness and safety of the treatment of Newvast® Tab(Atorvastatin) in real-practice. During the routine medical visit, according to the investigator's judgment, with diagnosis that the Newvast® Tab(Atorvastatin) prescription is appropriate, regardless of medical history and concomitant-medication, and after deciding to start treatment, patients with Dyslipidemia who agreed to participate in the study were administered Newvast® Tab(Atorvastatin). As this study is a non-interventional observational study, all subjects received prescriptions according to the routine treatment procedure, and there were no visits or procedures required according to the observational study protocol.

Detailed description

This study is a multicenter, prospective, non-interventional, observational study of patients administering Atorvastatin(Newvast® Tab) to treat Dyslipidemia. Data will be collected from patients receiving routine treatment at hospitals in South Korea. Each subject visits the institution according to the protocol that designed the follow-up visits for six months to examine the effectiveness and safety of Atorvastatin(Newvast® Tab). This study will approved by the institutions' IRBs and is in compliance with clinical research ethics regulations.

Conditions

• Dyslipidemia

Interventions

Type	Name	Description
DRUG	single arm, single group(No interventional)	(Newvast® Tab, 10 to 80 mg daily administered per the locally approved product information)

Timeline

• Start date: 2020-01-16
• Primary completion: 2022-01-27
• Completion: 2022-01-27
• First posted: 2022-09-26
• Last updated: 2022-09-26

Locations

1 site across 1 country: South Korea