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

NCT ID: NCT05555238

Last Updated: 2022-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1716 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-16

Study Completion Date

2022-01-27

Brief Summary

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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.

Detailed Description

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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

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Dyslipidemia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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single arm, single group(No interventional)

(Newvast® Tab, 10 to 80 mg daily administered per the locally approved product information)

Intervention Type DRUG

Other Intervention Names

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Observational

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ji-yeon Hong, PM

Role: STUDY_DIRECTOR

Hanmi Pharmaceutical Company Limited

Locations

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Hanmi Pharmaceutical Company Limited

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HM-NEW-OS-1901

Identifier Type: -

Identifier Source: org_study_id

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