Completed
Phase 3 Study to Evaluate the Efficacy and Safety of the DW0929 in Patients With Primary Hypercholesterolemia
What is being tested
DW-0929
+ Rosuvastatin
Drug
Who is being recruted
Hypercholesterolemia+3
+ Hyperlipidemias
+ Metabolic Diseases
Over 19 Years
+24 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Study Start: November 2014
Summary
Principal SponsorDaewon Pharmaceutical Co., Ltd.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: November 1, 2014
Actual date on which the first participant was enrolled.The purpose of this study is to evaluate the efficacy and safety of the DW0929 in patients with primary hypercholesterolemia
Official TitlePhase 3 Study to Evaluate the Efficacy and Safety of the DW0929 in Patients With Primary Hypercholesterolemia
Principal SponsorDaewon Pharmaceutical Co., Ltd.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
348 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 19 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
HypercholesterolemiaHyperlipidemiasMetabolic DiseasesNutritional and Metabolic DiseasesDyslipidemiasLipid Metabolism Disorders
Criteria
4 inclusion criteria required to participate
Adult over 19years
Patients with primary hypercholesterolemia whose LDL-C level is below 250mg/dL and TG level is below 350mg/dL
Patients whose LDL-C level is under 'Anti- dyslipidemia drug administration considered standard' of NCEP ATP III(2004)
Those who voluntarily written consent to participate in this clinical trial
20 exclusion criteria prevent from participating
Uncontrolled hypertension
Severe renal impairment(CrCl<30mL/min)
Those who have active liver disease and whose ALT, AST levels greater than twice the upper limit of normal
Serum creatinine > 2.0mg/dL
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalDW-0929
Group II
Active ComparatorRosuvastatin
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
CompletedOne Study Center