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

Phase 3

Recruiting

• Conditions: Cardiovascular Diseases
• Interventions: Drug: NVP-2203-R3; Drug: NVP-2203; Drug: NVP-2203-R2; Drug: NVP-2203-R1; Drug: NVP-2203-R1 Placebo; Drug: NVP-2203 Placebo; Drug: NVP-2203-R3 Placebo; Drug: NVP-2203-R2 Placebo

• Registration Number: NCT05856487
• Lead Sponsor: NVP Healthcare

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

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-03
• Study First Submitted QC: 2023-05-03
• Study First Posted: 2023-05-12
• Study Start: 2023-06-30
• Last Update Submitted: 2024-03-21
• Last Update Posted: 2024-03-22
• Primary Completion: 2024-05-31
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 228

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NVP-2203	NVP-2203-R3 Placebo	NVP-2203 Plus other Placebo for up to 8 weeks, oral dose
NVP-2203	NVP-2203-R1 Placebo	NVP-2203 Plus other Placebo for up to 8 weeks, oral dose
NVP-2203-R2	NVP-2203-R1 Placebo	NVP-2203-R2 Plus other Placebo for up to 8 weeks, oral dose
NVP-2203-R3	NVP-2203 Placebo	NVP-2203-R3 Plus other Placebo for up to 8 weeks, oral dose
NVP-2203-R3	NVP-2203-R2 Placebo	NVP-2203-R3 Plus other Placebo for up to 8 weeks, oral dose
NVP-2203-R3	NVP-2203-R3	NVP-2203-R3 Plus other Placebo for up to 8 weeks, oral dose
NVP-2203-R1	NVP-2203 Placebo	NVP-2203-R1 Plus other Placebo for up to 8 weeks, oral dose
NVP-2203-R1	NVP-2203-R2 Placebo	NVP-2203-R1 Plus other Placebo for up to 8 weeks, oral dose
NVP-2203	NVP-2203-R2 Placebo	NVP-2203 Plus other Placebo for up to 8 weeks, oral dose
NVP-2203-R3	NVP-2203-R1 Placebo	NVP-2203-R3 Plus other Placebo for up to 8 weeks, oral dose
NVP-2203-R2	NVP-2203 Placebo	NVP-2203-R2 Plus other Placebo for up to 8 weeks, oral dose
NVP-2203	NVP-2203	NVP-2203 Plus other Placebo for up to 8 weeks, oral dose
NVP-2203-R2	NVP-2203-R3 Placebo	NVP-2203-R2 Plus other Placebo for up to 8 weeks, oral dose
NVP-2203-R2	NVP-2203-R2	NVP-2203-R2 Plus other Placebo for up to 8 weeks, oral dose
NVP-2203-R1	NVP-2203-R1	NVP-2203-R1 Plus other Placebo for up to 8 weeks, oral dose

Primary Outcome Measures

Name	Time	Method
% change in LDL-C level from baseline	Week 8	change in LDL-C level

Secondary Outcome Measures

Name	Time	Method
% change in lipid panel from baseline	Week 4, 8	change in lipid panel

Trial Locations

Locations (1)

NVPhealthcare; 🇰🇷 Suwon-si, Gyeonggi-do, Korea, Republic of