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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00001154 -
Lipoprotein Metabolism in Normal Volunteers and Patients With High Levels of Lipoproteins
|
||
Not yet recruiting |
NCT06405880 -
Pharmacist Case Finding and Intervention for Vascular Prevention Trial
|
N/A | |
Recruiting |
NCT02837367 -
Use of Nutrigenomic Models for the Personalized Treatment With Medical Foods in Obese People
|
N/A | |
Active, not recruiting |
NCT02223793 -
Vascular Lifestyle-Intervention and Screening in Pharmacy
|
N/A | |
Active, not recruiting |
NCT02600338 -
Meta-analyses of the Effect of Legumes on Blood Pressure
|
N/A | |
Completed |
NCT02163044 -
The Hellenic Postprandial Lipemia Study (HPLS)
|
||
Recruiting |
NCT01972113 -
Vitamin K and Glucose Metabolism in Children at Risk for Diabetes (Vita-K 'n' Kids Study)
|
N/A | |
Recruiting |
NCT01705873 -
Analysis on the Risk of Cardiovascular Events in HIV- Infected Subjects Treated With LPV/r Based HAART Regimen vs. an EFV Based Regimen
|
N/A | |
Completed |
NCT01764295 -
Clinical Study for Patients With Hypertension Associated With Dyslipidemia
|
Phase 3 | |
Completed |
NCT01990391 -
Brazil Nut Consumption in Microvascular Endothelial Function, Oxidative Stress and Metabolic Abnormalities
|
N/A | |
Terminated |
NCT01414166 -
Niacin/Laropiprant Tablet for South and Southeast Asians With Low High-Density Lipoprotein Cholesterol (LDL-C) at Risk for Cardiovascular Disease (MK-0524A-108)
|
Phase 3 | |
Completed |
NCT01531062 -
Effect of Nigella Sativa on Lipid Profiles in Elderly
|
Phase 2 | |
Recruiting |
NCT01670968 -
HIV Reverse Cholesterol Transport Study
|
||
Completed |
NCT00977288 -
A Study of Safety and Efficacy of MK0859 (Anacetrapib) in Japanese Patients With Dyslipidemia (0859-029)
|
Phase 2 | |
Withdrawn |
NCT00664287 -
Extended Release (ER) Niacin/Laropiprant Add on Study (0524A-082)
|
Phase 3 | |
Completed |
NCT01285544 -
The Efficacy and Tolerability of Two Formulations of Atorvastatin In Korean Adult With Hypercholesterolemia
|
Phase 4 | |
Completed |
NCT00768274 -
Safety, Pharmacokinetic Study of RVX000222 in Healthy Subjects and Subjects With Low HDL Cholesterol
|
Phase 1/Phase 2 | |
Completed |
NCT00300430 -
Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia.
|
Phase 3 | |
Completed |
NCT01483235 -
Reduced Cardiac Rehabilitation Program
|
N/A | |
Completed |
NCT00143663 -
Effect of Lapaquistat Acetate on Blood Cholesterol Levels in Subjects With Elevated Cholesterol
|
Phase 3 |