Phase 3 Study to Evaluate the Efficacy and Safety of the DW0929 in Patients With Primary Hypercholesterolemia
NCT ID: NCT02390375
Last Updated: 2016-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
348 participants
INTERVENTIONAL
2014-11-30
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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A
DW-0929
DW-0929
5/10mg
DW-0929
10/10mg
DW-0929
20/10mg
B
Rosuvastatin
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
ALL
No
Sponsors
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Daewon Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Boramae Hospital
Seoul, Dongjak-gu, South Korea
Countries
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Other Identifiers
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DW-0929_P301
Identifier Type: -
Identifier Source: org_study_id
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