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

Hypercholesterolemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02390375
• Other study ID #: DW-0929_P301
• Status: Completed
• Phase: Phase 3
• First received: March 11, 2015
• Last updated: October 7, 2016
• Start date: November 2014
• Est. completion date: May 2016

Study information

• Verified date: October 2016
• Source: Daewon Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 348
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• DW-0929
5/10mg
• DW-0929
10/10mg
• DW-0929
20/10mg
• Rosuvastatin
5mg F/U study: DW-0929 5/10mg
• Rosuvastatin
10mg F/U study: DW-0929 10/10mg
• Rosuvastatin
20mg F/U study: DW-0929 20/10mg

Locations

Country	Name	City	State
Korea, Republic of	Boramae Hospital	Seoul	Dongjak-gu

Sponsors (1)

Lead Sponsor	Collaborator
Daewon Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL-C level		8 weeks	No