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

Phase 3

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: DW-0929; Drug: Rosuvastatin

• Registration Number: NCT02390375
• Lead Sponsor: Daewon Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-03-11
• Study First Submitted QC: 2015-03-16
• Study First Posted: 2015-03-17
• Primary Completion: 2016-04
• Study Completion: 2016-05
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-07
• Last Update Posted: 2016-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 348

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
A	DW-0929	DW-0929
B	DW-0929	Rosuvastatin
B	Rosuvastatin	Rosuvastatin

Primary Outcome Measures

Name	Time	Method
LDL-C level	8 weeks

Trial Locations

Locations (1)

Boramae Hospital; 🇰🇷 Seoul, Dongjak-gu, Korea, Republic of