Phase 3 Study to Evaluate the Efficacy and Safety of the DW0929 in Patients With Primary Hypercholesterolemia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02390375

Enrollment

348

Registered

2015-03-17

Start date

2014-11-30

Completion date

2016-05-31

Last updated

2016-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Brief summary

The purpose of this study is to evaluate the efficacy and safety of the DW0929 in patients with primary hypercholesterolemia

Interventions

DRUGDW-0929

5/10mg

DRUGRosuvastatin

5mg F/U study: DW-0929 5/10mg

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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 * Those who have been geunyukbyeong or rhabdomyolysis caused by using statin or have hypersensitivity to ezetimibe * Combined cyclosporine -treated patients * HbA1c ≥ 9% * TSH ≥ 1.5 X ULN * HIV-positive person * Congestive heart failure patients classified as NYHA Class III or IV * Patients with uncontrolled arrhythmias * Patients who have malignant tumors needed chemotherapy, radiation therapy, etc. * Blood clotting disorders * Patients who had a myocardial infarction within 6 months or cardiovascular bypass surgery, patients who have underwent angioplasty * Patients who had a history of anxiety or severe typical peripheral arterial disease within three months * Women of childbearing age who don't agree with contraception during this clinical trials * Pregnant women or nursing mothers * Those who take the drug in combination taboo * Who have been treated for another investigational drug within 30 days * Unsuitable characters in a clinical trial to test self- determination

Design outcomes

Primary

Measure	Time frame
LDL-C level	8 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026