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NCT05809687 Clinical Trial

Phase 3 Trial to Evaluate the Efficacy and Safety of DKP21102_B Added on to DKP21102_A Compared With DKP21102_A

Dyslipidemias Clinical Trial

Official title:
Evaluate Efficacy and Safety of DKP21102_B Added on to DKP21102_A Compared With DKP21102_A in Mixed Dyslipidemia Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05809687
Other study ID # DKP21102_301
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date July 1, 2024
Est. completion date December 1, 2027

Study information
Verified date March 2023
Source Dongkwang Pharm. Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Phase 3 study to evaluate the efficacy and safety of DKP21102_B Added on to DKP21102_A Compared with DKP21102_A

Description:

Phase 3 study to evaluate the efficacy and safety of DKP21102 in patients with mixed dyslipidemia where LDL-C is properly controlled but triglyceride and HDL-C levels are not regulated by DKP21102_A alone.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 512
Est. completion date December 1, 2027
Est. primary completion date December 1, 2026
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - A man or woman over 19 years old. - Patients with coronary heart disease or risk of coronary heart disease Exclusion Criteria: - History of Unstable angina, myocardial infarction etc - Uncontrolled hypo-thyroidism (TSH=1.5XULN), Diabetes(HbA1c = 9.0%) - renal impairment (Creatinine clearance < 60 mL/min) etc.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• DKP21102_C
Placebo
• DKP21102_B
Treatment
• DKP21102_A
Active Control

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Dongkwang Pharm. Co., Ltd.

Outcome
Type Measure Description Time frame Safety issue
Primary Percent change (%) of non-HDL-C from baseline non-HDL-C from baseline at 12weeks
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