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NCT05856487 Clinical Trial

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

Cardiovascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05856487
Other study ID # NVP-2203_P3
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date June 30, 2023
Est. completion date October 31, 2024

Study information
Verified date May 2023
Source NVP Healthcare
Contact HR Lim
Phone +82-31-547-9781
Email hrlim@nvp-healthcare.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Recruiting
Enrollment 228
Est. completion date October 31, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• NVP-2203
Take it once daily for 8 weeks orally.
• NVP-2203-R1
Take it once daily for 8 weeks orally.
• NVP-2203-R2
Take it once daily for 8 weeks orally.
• NVP-2203-R3
Take it once daily for 8 weeks orally.
• NVP-2203 Placebo
Take it once daily for 8 weeks orally.
• NVP-2203-R1 Placebo
Take it once daily for 8 weeks orally.
• NVP-2203-R2 Placebo
Take it once daily for 8 weeks orally.
• NVP-2203-R3 Placebo
Take it once daily for 8 weeks orally.

Locations
Country Name City State
Korea, Republic of NVPhealthcare Suwon-si Gyeonggi-do

Sponsors (1)
Lead Sponsor Collaborator
NVP Healthcare

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary % change in LDL-C level from baseline change in LDL-C level Week 8
Secondary % change in lipid panel from baseline change in lipid panel Week 4, 8
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