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

• Sponsor: Hanmi Pharmaceutical Company Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05555238
• Collaborator: (none)
• Enrollment: 1,716
• Location: 1
• Actual Duration (Months): 24.4
• Patients Per Site Per Month: 70.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemia	Drug: single arm, single group(No interventional)

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 1716 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: An Observational Study to Evaluate the Safety and Effectiveness of Newvast Tab(Atorvastatin) in Korean Dyslipidemia Patients
• Actual Study Start Date: Jan 16, 2020
• Actual Primary Completion Date: Jan 27, 2022
• Actual Study Completion Date: Jan 27, 2022

Outcome Measures

Primary Outcome Measures

1. The incidence of myalgia [6 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hanmi Pharmaceutical Company Limited	Seoul		Korea, Republic of	05545

Sponsors and Collaborators

• Hanmi Pharmaceutical Company Limited

Investigators

• Study Director: Ji-yeon Hong, PM, Hanmi Pharmaceutical Company Limited

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hanmi Pharmaceutical Company Limited
• ClinicalTrials.gov Identifier: NCT05555238
• Other Study ID Numbers: HM-NEW-OS-1901
• First Posted: Sep 26, 2022
• Last Update Posted: Sep 26, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hanmi Pharmaceutical Company Limited: Dyslipidemia; Atorvastatin; Statin
• Additional relevant MeSH terms: Dyslipidemias

Study Results

No Results Posted as of Sep 26, 2022