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

Sponsor

NVP Healthcare (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05856487

Collaborator

(none)

228

Enrollment

Arms

17.1

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases	Drug: NVP-2203 Drug: NVP-2203-R1 Drug: NVP-2203-R2 Drug: NVP-2203-R3 Drug: NVP-2203 Placebo Drug: NVP-2203-R1 Placebo Drug: NVP-2203-R2 Placebo Drug: NVP-2203-R3 Placebo	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

228 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 30, 2023

Anticipated Primary Completion Date :

Mar 31, 2024

Anticipated Study Completion Date :

Oct 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NVP-2203 NVP-2203 Plus other Placebo for up to 8 weeks, oral dose	Drug: NVP-2203 Take it once daily for 8 weeks orally. Drug: NVP-2203-R1 Placebo Take it once daily for 8 weeks orally. Drug: NVP-2203-R2 Placebo Take it once daily for 8 weeks orally. Drug: NVP-2203-R3 Placebo Take it once daily for 8 weeks orally.
Active Comparator: NVP-2203-R1 NVP-2203-R1 Plus other Placebo for up to 8 weeks, oral dose	Drug: NVP-2203-R1 Take it once daily for 8 weeks orally. Drug: NVP-2203 Placebo Take it once daily for 8 weeks orally. Drug: NVP-2203-R2 Placebo Take it once daily for 8 weeks orally.
Active Comparator: NVP-2203-R2 NVP-2203-R2 Plus other Placebo for up to 8 weeks, oral dose	Drug: NVP-2203-R2 Take it once daily for 8 weeks orally. Drug: NVP-2203 Placebo Take it once daily for 8 weeks orally. Drug: NVP-2203-R1 Placebo Take it once daily for 8 weeks orally. Drug: NVP-2203-R3 Placebo Take it once daily for 8 weeks orally.
Active Comparator: NVP-2203-R3 NVP-2203-R3 Plus other Placebo for up to 8 weeks, oral dose	Drug: NVP-2203-R3 Take it once daily for 8 weeks orally. Drug: NVP-2203 Placebo Take it once daily for 8 weeks orally. Drug: NVP-2203-R1 Placebo Take it once daily for 8 weeks orally. Drug: NVP-2203-R2 Placebo Take it once daily for 8 weeks orally.

Outcome Measures

Primary Outcome Measures

% change in LDL-C level from baseline [Week 8]
change in LDL-C level

Secondary Outcome Measures

% change in lipid panel from baseline [Week 4, 8]
change in lipid panel

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

NVP Healthcare

Investigators

Principal Investigator: SH Lee, MD, Severance Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NVP Healthcare

ClinicalTrials.gov Identifier:

NCT05856487

Other Study ID Numbers:

NVP-2203_P3

First Posted:

May 12, 2023

Last Update Posted:

May 12, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cardiovascular Diseases

Study Results

No Results Posted as of May 12, 2023