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

NCT ID: NCT05856487

Last Updated: 2024-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-30

Study Completion Date

2024-10-31

Brief Summary

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

Detailed Description

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

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NVP-2203

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

Group Type EXPERIMENTAL

NVP-2203

Intervention Type DRUG

Take it once daily for 8 weeks orally.

NVP-2203-R1 Placebo

Intervention Type DRUG

Take it once daily for 8 weeks orally.

NVP-2203-R2 Placebo

Intervention Type DRUG

Take it once daily for 8 weeks orally.

NVP-2203-R3 Placebo

Intervention Type DRUG

Take it once daily for 8 weeks orally.

NVP-2203-R1

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

Group Type ACTIVE_COMPARATOR

NVP-2203-R1

Intervention Type DRUG

Take it once daily for 8 weeks orally.

NVP-2203 Placebo

Intervention Type DRUG

Take it once daily for 8 weeks orally.

NVP-2203-R2 Placebo

Intervention Type DRUG

Take it once daily for 8 weeks orally.

NVP-2203-R2

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

Group Type ACTIVE_COMPARATOR

NVP-2203-R2

Intervention Type DRUG

Take it once daily for 8 weeks orally.

NVP-2203 Placebo

Intervention Type DRUG

Take it once daily for 8 weeks orally.

NVP-2203-R1 Placebo

Intervention Type DRUG

Take it once daily for 8 weeks orally.

NVP-2203-R3 Placebo

Intervention Type DRUG

Take it once daily for 8 weeks orally.

NVP-2203-R3

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

Group Type ACTIVE_COMPARATOR

NVP-2203-R3

Intervention Type DRUG

Take it once daily for 8 weeks orally.

NVP-2203 Placebo

Intervention Type DRUG

Take it once daily for 8 weeks orally.

NVP-2203-R1 Placebo

Intervention Type DRUG

Take it once daily for 8 weeks orally.

NVP-2203-R2 Placebo

Intervention Type DRUG

Take it once daily for 8 weeks orally.

Interventions

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NVP-2203

Take it once daily for 8 weeks orally.

Intervention Type DRUG

NVP-2203-R1

Take it once daily for 8 weeks orally.

Intervention Type DRUG

NVP-2203-R2

Take it once daily for 8 weeks orally.

Intervention Type DRUG

NVP-2203-R3

Take it once daily for 8 weeks orally.

Intervention Type DRUG

NVP-2203 Placebo

Take it once daily for 8 weeks orally.

Intervention Type DRUG

NVP-2203-R1 Placebo

Take it once daily for 8 weeks orally.

Intervention Type DRUG

NVP-2203-R2 Placebo

Take it once daily for 8 weeks orally.

Intervention Type DRUG

NVP-2203-R3 Placebo

Take it once daily for 8 weeks orally.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NVP Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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SH Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

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NVPhealthcare

Suwon, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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HR Lim

Role: CONTACT

+82-31-547-9781

AY Ji

Role: CONTACT

+82-31-895-4636

Facility Contacts

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Role: primary

Other Identifiers

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NVP-2203_P3

Identifier Type: -

Identifier Source: org_study_id

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