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

NVP Healthcare

Status and phase: Enrolling; Phase 3

Conditions: Cardiovascular Diseases

Treatments: Drug: NVP-2203-R3 Placebo; Drug: NVP-2203-R2; Drug: NVP-2203 Placebo; Drug: NVP-2203-R2 Placebo; Drug: NVP-2203-R1; Drug: NVP-2203-R1 Placebo; Drug: NVP-2203-R3; Drug: NVP-2203

Study type: Interventional

Funder types: Industry

Identifiers

NCT05856487

NVP-2203_P3

Details and patient eligibility

About

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

Full 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

Enrollment: 228 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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228 participants in 4 patient groups

NVP-2203

Experimental group

Description:

NVP-2203 Plus other Placebo for up to 8 weeks, oral dose

Treatment:

Drug: NVP-2203-R1 Placebo

Drug: NVP-2203-R2 Placebo

Drug: NVP-2203

Drug: NVP-2203-R3 Placebo

NVP-2203-R1

Active Comparator group

Description:

NVP-2203-R1 Plus other Placebo for up to 8 weeks, oral dose

Treatment:

Drug: NVP-2203 Placebo

Drug: NVP-2203-R2 Placebo

Drug: NVP-2203-R1

NVP-2203-R2

Active Comparator group

Description:

NVP-2203-R2 Plus other Placebo for up to 8 weeks, oral dose

Treatment:

Drug: NVP-2203-R1 Placebo

Drug: NVP-2203 Placebo

Drug: NVP-2203-R2

Drug: NVP-2203-R3 Placebo

NVP-2203-R3

Active Comparator group

Description:

NVP-2203-R3 Plus other Placebo for up to 8 weeks, oral dose

Treatment:

Drug: NVP-2203-R1 Placebo

Drug: NVP-2203 Placebo

Drug: NVP-2203-R2 Placebo

Drug: NVP-2203-R3