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

Daewon Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia

Treatments: Drug: Rosuvastatin; Drug: DW-0929

Study type: Interventional

Funder types: Industry

Identifiers

NCT02390375

DW-0929_P301

Details and patient eligibility

About

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

Enrollment: 348 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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348 participants in 2 patient groups

A

Experimental group

Description:

DW-0929

Treatment:

Drug: DW-0929

Drug: DW-0929

Drug: DW-0929

B

Active Comparator group

Description:

Rosuvastatin

Treatment:

Drug: Rosuvastatin

Drug: Rosuvastatin

Drug: Rosuvastatin

Drug: DW-0929

Drug: DW-0929

Drug: DW-0929