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

Completed

• Conditions: Dyslipidemia

• Registration Number: NCT05555238
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief 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.

Study Timeline

• Study Start: 2020-01-16
• Primary Completion: 2022-01-27
• Study Completion: 2022-01-27
• Status Verified: 2022-08
• Study First Submitted: 2022-09-22
• Study First Submitted QC: 2022-09-22
• Last Update Submitted: 2022-09-22
• Study First Posted: 2022-09-26
• Last Update Posted: 2022-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1716

Inclusion Criteria

1. Patient was diagnosed with Dyslipidemia
2. Those who voluntarily consented in writing to this study

Exclusion Criteria

(1) Patients for whom use of Newvast® Tab is prohibited

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of myalgia	6 months	The incidence of myalgia associated with Newvast® Tab(Atorvastatin) treatment

Trial Locations

Locations (1)

Hanmi Pharmaceutical Company Limited; 🇰🇷 Seoul, Korea, Republic of