To Evaluate the Safety and Efficacy of NVP-2203 Tablet in Patients

A Multicenter, Randomized, Double-blind, Parallel-group, Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of NVP-2203 Tablet in Patients

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05856487

Enrollment

228

Registered

2023-05-12

Start date

2023-06-30

Completion date

2024-10-31

Last updated

2024-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

Brief summary

The purpose of this study is to evaluate the efficacy and safety NVP-2203 in patients

Detailed description

This study is a multicenter, randomized, double-blind, parallel-group, phase 3 clinical trial to evaluate efficacy and safety of NVP-2203 in patients

Interventions

Take it once daily for 8 weeks orally.

DRUGNVP-2203-R1

Take it once daily for 8 weeks orally.

DRUGNVP-2203-R2

Take it once daily for 8 weeks orally.

DRUGNVP-2203-R3

Take it once daily for 8 weeks orally.

DRUGNVP-2203 Placebo

Take it once daily for 8 weeks orally.

DRUGNVP-2203-R1 Placebo

Take it once daily for 8 weeks orally.

DRUGNVP-2203-R2 Placebo

Take it once daily for 8 weeks orally.

DRUGNVP-2203-R3 Placebo

Take it once daily for 8 weeks orally.

Sponsors

NVP Healthcare

Lead SponsorINDUSTRY

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Adults ≥ 19 years of age * Primary hypercholesterolemia * Subjects who have ability to comprehend the contents of study and before participating in trial and have willingness to sign of informed consent in writing

Exclusion criteria

* The subject not meet the specified LDL-C level * Patients who were diagnosed with a malignant tumor within five years before Visit * Inadequate subject for the clinical trial by the investigator's decision

Design outcomes

Primary

Measure	Time frame	Description
% change in LDL-C level from baseline	Week 8	change in LDL-C level

Secondary

Measure	Time frame	Description
% change in lipid panel from baseline	Week 4, 8	change in lipid panel

Countries

South Korea

Contacts

Primary ContactHR Lim

hrlim@nvp-healthcare.com+82-31-547-9781

Backup ContactAY Ji

jay94@nvp-healthcare.com+82-31-895-4636

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026