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

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daewon Pharmaceutical Co., Ltd.
• Treatments: Rosuvastatin Calcium

Criteria

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