Clinical Trial of YH14755 in Subjects With Dyslipidemia and Type II Diabetes
NCT ID: NCT02586129
Last Updated: 2018-10-03
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
249 participants
INTERVENTIONAL
2015-11-04
2017-07-07
Brief Summary
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Detailed Description
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In YH14755 treatment group, 88 subjects will be assigned and the subjects administer YH14755 for 16 weeks.
In Metformin treatment group, 88 subjects will be assigned and the subjects administer Metformin for 16 weeks.
In Rosuvastatin treatment group, 88 subjects will be assigned and the subjects administer Rosuvastatin for 16 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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YH14755
PO, Once Daily, 16 weeks
YH14755
20/1500mg, QD
Metformin
PO, Once Daily, 16 weeks
Metformin
1500mg, QD
Rosuvastatin
PO, Once Daily, 16 weeks
Rosuvastatin
20mg, QD
Interventions
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YH14755
20/1500mg, QD
Metformin
1500mg, QD
Rosuvastatin
20mg, QD
Eligibility Criteria
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Inclusion Criteria
* Subjects with Dyslipidemia and Type II Diabetes
* 6.5% ≤ HbA1c level ≤ 9.0% and LDL-C level ≤ 250mg/dL(6.5 nmal/L) at screening
* BMI ≤ 45kg/m2
* Subjects who dose not administered diabetes treatment at least 4 weeks prior to screening visit.
* 19 years later, men and women under the age of 75
Exclusion Criteria
* Subject with type I Diabetes
* Subject with hypertension which does not controlled by treatment(have blood pressure \> 160/110mmHg)
* Have a known allergy to drugs
* Have administered Cyclosporine
* Have administered Obesity treatment within 12 weeks prior to screening visit
* Participated in any other clinical trials within 30 days prior to the first administration
* Subject who is judged to be ineligible by investigator
19 Years
75 Years
ALL
No
Sponsors
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Yuhan Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Hakcheol Jang, M.D., Ph.D.
Role: STUDY_CHAIR
Department of Internal Medicine, SNU Bundang Hospital
Locations
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Seoul National Universitiy Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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YH14755-301
Identifier Type: -
Identifier Source: org_study_id
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