NCT05555238

Completed

An Observational Study to Evaluate the Treatment of Newvast®...

Hanmi Pharmaceutical Company Limited Source

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Other study identifiers

Sponsor study identifier

HM-NEW-OS-1901

Study Type

observational

Actual enrollment (reported)

1,716

Locations

1 country

Sites

1

Timeline

Study Start

January 16, 2020

Actual (reported)

Primary Completion

January 27, 2022

Actual (reported)

Study Completion

January 27, 2022

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 1,716 participants
Study completion date: January 27, 2022
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 16, 2020
Actual (reported)
Primary Completion
January 27, 2022
Actual (reported)
Study Completion
January 27, 2022
Actual (reported)
First Submitted
September 22, 2022
Actual (reported)
First Posted
September 26, 2022
Actual (reported)

Last Updated: September 26, 2022
Status Verified: August 2022
Last Update Submitted: September 22, 2022

Conditions

Dyslipidemia

Keywords

DyslipidemiaAtorvastatinStatin

Outcome Measures

Primary Outcomes (1)

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

Interventions

single arm, single group(No interventional)Drug

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

Also known as: Observational

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Dyslipidemia

You may qualify if:

Patient was diagnosed with Dyslipidemia

Sponsors & Collaborators

Hanmi Pharmaceutical Company Limited
Industrylead

Study Sites (1)

Hanmi Pharmaceutical Company Limited

Seoul, 05545, South Korea

MeSH Terms

Conditions

Dyslipidemias

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

Ji-yeon Hong, PM
Hanmi Pharmaceutical Company Limited
STUDY DIRECTOR

Enrollment

1,716 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: OTHER
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 22, 2022

First Posted

September 26, 2022

Study Start

January 16, 2020

Actual (reported)

NCT05614765

Evaluation of Dyslipidemia Management After Statin and Ezetimibe Complex Treatment

Active Not Recruiting

NCT03730038

Effects of Pitavastatin Treatments on the Plasma Lgi3 Level in the Patients With Dyslipidemia

Not ApplicableCompleted

NCT04874142

Phase 1 to Evaluate the Safety and Pharmacokinetic Durg-drug Interaction of YYC506-T and YYC506-A

Phase 1Completed

NCT03773315

Ulmus Macrocarpa Hance Extract and Lipid Profile

Not ApplicableCompleted

NCT04772443

Evaluate the Efficacy and Safety of DWJ1506 and DWJ1507

Phase 3Unknown

NCT04874129

Phase 1 to Evaluate the Safety and Pharmacokinetic Characteristics of Fixed-dose Combination of YYC506

Phase 1Unknown

Those who voluntarily consented in writing to this study

You may not qualify if:

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

Contact the study team to confirm eligibility.

Primary Completion

January 27, 2022

Actual (reported)

Study Completion

January 27, 2022

Actual (reported)

Last Updated

September 26, 2022

Record last verified: 2022-08

Source record

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Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05555238
Data provider: ClinicalTrials.gov
Source updated: 2022-09-26
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:19:01 UTC

Locations

KR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations