To Evaluate the Safety and Efficacy of NVP-2203 Tablet in Patients
A Multicenter, Randomized, Double-blind, Parallel-group, Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of NVP-2203 Tablet in Patients
1 other identifier
interventional
228
1 country
1
Brief Summary
The purpose of this study is to evaluate the efficacy and safety NVP-2203 in patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 cardiovascular-diseases
Started Jun 2023
Shorter than P25 for phase_3 cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2023
CompletedFirst Posted
Study publicly available on registry
May 12, 2023
CompletedStudy Start
First participant enrolled
June 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2024
CompletedMarch 22, 2024
May 1, 2023
11 months
May 3, 2023
March 21, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
% change in LDL-C level from baseline
change in LDL-C level
Week 8
Secondary Outcomes (1)
% change in lipid panel from baseline
Week 4, 8
Study Arms (4)
NVP-2203
EXPERIMENTALNVP-2203 Plus other Placebo for up to 8 weeks, oral dose
NVP-2203-R1
ACTIVE COMPARATORNVP-2203-R1 Plus other Placebo for up to 8 weeks, oral dose
NVP-2203-R2
ACTIVE COMPARATORNVP-2203-R2 Plus other Placebo for up to 8 weeks, oral dose
NVP-2203-R3
ACTIVE COMPARATORNVP-2203-R3 Plus other Placebo for up to 8 weeks, oral dose
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NVP Healthcarelead
Study Sites (1)
NVPhealthcare
Suwon, Gyeonggi-do, 16209, South Korea
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
SH Lee, MD
Severance Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2023
First Posted
May 12, 2023
Study Start
June 30, 2023
Primary Completion
May 31, 2024
Study Completion
October 31, 2024
Last Updated
March 22, 2024
Record last verified: 2023-05