NCT05555238

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,716

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 16, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2022

Completed
Last Updated

September 26, 2022

Status Verified

August 1, 2022

Enrollment Period

2 years

First QC Date

September 22, 2022

Last Update Submit

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

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
  • 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.

Sponsors & Collaborators

Study Sites (1)

Hanmi Pharmaceutical Company Limited

Seoul, 05545, South Korea

Location

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

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

Primary Completion

January 27, 2022

Study Completion

January 27, 2022

Last Updated

September 26, 2022

Record last verified: 2022-08

Locations

KR(1)