Dyslipidemia Clinical Trial
Official title:
Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Trial to Evaluate the Safety and Efficacy of YH14755 in Subjects With Dyslipidemia and Type II Diabetes
Verified date | October 2018 |
Source | Yuhan Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Randomized, double-blind, active-controlled, multicenter phase 3 trial to evaluate the safety and efficacy of YH14755 in subjects with dyslipidemia and Type II Diabetes.
Status | Completed |
Enrollment | 249 |
Est. completion date | July 7, 2017 |
Est. primary completion date | July 7, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Signed Informed Consent - 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: - Pregnant women, nursing mothers or subject who does not agree to assigned contraception in the study - 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National Universitiy Bundang Hospital | Seongnam-Si | Gyeonggi-Do |
Lead Sponsor | Collaborator |
---|---|
Yuhan Corporation |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in LDL Cholesterol | Change from baseline at 16 weeks | ||
Primary | Change in HbA1c | Change from baseline at 16 weeks |
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