Mixed Dyslipidemia Clinical Trial
Official title:
A Randomized, Double-blinded, Active-controlled, Multicenter Phase 3 Clinical Trial and Open-label, Extension Study to Evaluate the Efficacy and Safety of AD-218 in Patients With Mixed Dyslipidemia
The purpose of this study is to evaluate the efficacy and safety of AD-218
| Status | Recruiting |
| Enrollment | 520 |
| Est. completion date | June 30, 2025 |
| Est. primary completion date | March 31, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years and older |
| Eligibility | Inclusion Criteria: - A man or woman over 19 years old. - Sign on ICF prior to study participation Exclusion Criteria: - History of Fibromyalgia, Myopathy etc (CK = 2 X ULN) - Other exclusions applied |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Yeongnam University Hospital | Daegu | Nam-gu |
| Lead Sponsor | Collaborator |
|---|---|
| Addpharma Inc. |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percent change (%) of non-HDL-C from baseline at week 12 | non-HDL-C at week 12 compared AD-218 with AD-218A | from baseline at 12 weeks | |
| Secondary | Percent change (%) of non-HDL-C from baseline at week 4, 8 | non-HDL-C at week 4,8 compared AD-218 with AD-218A | from baseline at week 4,8 | |
| Secondary | Percent change (%) of Lipid panel from baseline at week 4, 8, 12 | Lipid panel at week 4, 8, 12 compared AD-218 with AD-218A | from baseline at week 4, 8, 12 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04998201 -
Study of ARO-APOC3 in Adults With Mixed Dyslipidemia
|
Phase 2 | |
| Not yet recruiting |
NCT03648788 -
A Post-marketing Surveillance to Assess Safety and Efficacy of Rosuvatatin/Ezetimibe
|
||
| 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 | |
| Recruiting |
NCT05399992 -
Study Evaluating Effectiveness and Adherence of Inclisiran Plus Standard of Care (SoC) Lipid-lowering Therapy Compared to SoC in ASCVD
|
||
| Withdrawn |
NCT05798390 -
Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe in Routine Clinical Practice in Patients With Primary Hypercholesterolemia Or Mixed Dyslipidemia
|
||
| Completed |
NCT01256476 -
Prevail-Us: A Study Of Pitavastatin 4 mg Vs. Pravastatin 40 mg In Patients With Primary Hyperlipidemia Or Mixed Dyslipidemia
|
Phase 4 | |
| Completed |
NCT00171236 -
Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia
|
Phase 3 | |
| Completed |
NCT00487591 -
An Evaluation of Simvastatin Plus Omacor Compared to Simvastatin Plus Placebo in Subjects With Mixed Dyslipidemia
|
Phase 4 | |
| Terminated |
NCT03433755 -
Safety and Efficacy of Evolocumab in Addition to Optimal Stable Background Statin Therapy in Chinese Participants With Primary Hypercholesterolemia and Mixed Dyslipidemia
|
Phase 3 | |
| Completed |
NCT02739984 -
Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed Dyslipidemia
|
Phase 3 | |
| Not yet recruiting |
NCT06386419 -
A Clinical Study to Evaluate the Safety and Effectiveness of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
|
Phase 4 | |
| Terminated |
NCT01335997 -
Efficacy and Safety of Extended-Release Niacin/ Laropiprant/Simvastatin Tablets in Participants With Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-143)
|
Phase 3 | |
| Completed |
NCT00300456 -
Evaluate Safety and Efficacy of ABT-335 in Combination With Simvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood
|
Phase 3 | |
| Completed |
NCT00300482 -
Evaluate Safety and Efficacy of ABT-335 in Combination With Rosuvastatin Calcium in Subjects With Multiple Abnormal Lipid Levels in the Blood
|
Phase 3 | |
| Completed |
NCT00300469 -
Evaluate Safety and Efficacy of ABT-335 in Combination With Atorvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood
|
Phase 3 | |
| Recruiting |
NCT06314919 -
A Study to Evaluate the Efficacy and Safety of Fixed-Dose Combination of Pitavastatin/Ezetimib
|
||
| Terminated |
NCT01274559 -
Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Patients With High Cholesterol or Abnormal Lipid Levels (MK-0524A-133)
|
Phase 3 | |
| Active, not recruiting |
NCT04832971 -
Study of ARO-ANG3 in Adults With Mixed Dyslipidemia
|
Phase 2 | |
| Completed |
NCT00491530 -
A Year 2, Safety Extension Study of the Combination of ABT-335 and Statin Therapy for Subjects With Mixed Dyslipidemia
|
Phase 3 | |
| Completed |
NCT00136799 -
Efficacy and Safety of Fluvastatin in Different Doses in Adults With Mixed Dyslipidemia or Primary Hypercholesterolemia
|
Phase 3 |