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NCT05555238 Clinical Trial

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

Dyslipidemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05555238
Other study ID # HM-NEW-OS-1901
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 16, 2020
Est. completion date January 27, 2022

Study information
Verified date August 2022
Source Hanmi Pharmaceutical Company Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1716
Est. completion date January 27, 2022
Est. primary completion date January 27, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• single arm, single group(No interventional)
(Newvast® Tab, 10 to 80 mg daily administered per the locally approved product information)

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