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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| single arm, single group(No interventional) | Drug | (Newvast® Tab, 10 to 80 mg daily administered per the locally approved product information) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of myalgia | The incidence of myalgia associated with Newvast® Tab(Atorvastatin) treatment | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
(1) Patients for whom use of Newvast® Tab is prohibited
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Dyslipidemia
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| Name | Affiliation | Role |
|---|---|---|
| Ji-yeon Hong, PM | Hanmi Pharmaceutical Company Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanmi Pharmaceutical Company Limited | Seoul | 05545 | South Korea |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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