Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg When Added to PCSK9 Inhibitor Therapy
NCT03193047 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59
Last updated 2020-04-03
Summary
The purpose of this study is to determine if bempedoic acid (ETC-1002) 180mg added to PCSK9 inhibitor (evolocumab) therapy is effective and safe in patients with elevated LDL cholesterol.
Conditions
Interventions
- DRUG
-
bempedoic acid 180mg
Daily bempedoic acid 180mg tablet in addition to monthly PCSK9i (evolocumab) background therapy
- OTHER
-
placebo
Daily matching placebo tablet in addition to monthly PCSK9i (evolocumab) background therapy
- DRUG
-
evolocumab
Monthly PCSK9i (evolocumab) background therapy
Sponsors & Collaborators
-
Esperion Therapeutics, Inc.
lead INDUSTRY
Principal Investigators
-
Ron Haberman, MD · Esperion Therapeutics, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-04-07
- Primary Completion
- 2018-01-29
- Completion
- 2018-02-19
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study-2
NCT01763918 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase II Study To Evaluate the Efficacy And Safety Of HRS-1301 In Participants With Dyslipidemia
NCT07229937 ·Status: RECRUITING ·Phase: PHASE2
-
Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Liposomal siRNA in Subjects With High Cholesterol
NCT00927459 ·Status: TERMINATED ·Phase: PHASE1
-
To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia (0653A-091)(COMPLETED)
NCT00271817 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Investigate the Effectiveness and Safety of Bempedoic Acid in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia in Taiwan
NCT06925100 ·Status: COMPLETED ·Phase: PHASE4
-
An Experimental Medicine Study to Evaluate Serum Biomarkers of Lipid Metabolism
NCT00847782 ·Status: COMPLETED ·Phase: NA
-
Comparison of SLx-4090 Combined With Statin Therapy Versus Statin Alone in Reducing LDL-C in Patients With Hyperlipidemia
NCT00810979 ·Status: COMPLETED ·Phase: PHASE2
-
Safety Study of BMS-770767 in Subjects With Hypercholesterolemia
NCT01058083 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety Study of ISIS 301012 (Mipomersen) as Add-on in Familial Hypercholesterolemic Patients With Coronary Artery Disease
NCT00706849 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Assess the Safety and Efficacy of ISIS 301012 (Mipomersen) in Homozygous Familial Hypercholesterolemia
NCT00607373 ·Status: COMPLETED ·Phase: PHASE3
-
Lipid Efficacy/Tolerability Study (0524A-020)
NCT00269204 ·Status: COMPLETED ·Phase: PHASE3
-
Assessment of Interaction Between Vytorin and Niaspan in Healthy Subjects (P04955AM2)
NCT00652431 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of Alirocumab on Postprandial Hyperlipemia in Patients With Type 2 Diabetes
NCT03344692 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia
NCT05621070 ·Status: RECRUITING ·Phase: PHASE3
-
A Safety Study of BMS-852927 in Subjects With Hypercholesterolemia
NCT01651273 ·Status: TERMINATED ·Phase: PHASE1
-
Efficacy of Lapaquistat Acetate Co-Administered With Current Lipid-Lowering Treatment on Blood Cholesterol Levels in Subjects With Homozygous Familial Hypercholesterolemia
NCT00263081 ·Status: TERMINATED ·Phase: PHASE3
-
A Study to Evaluate the Effects of Extended Release (ER) Niacin/Laropiprant, Laropiprant, ER Niacin, and Placebo on Urinary Prostanoid Metabolites in Subjects With High Cholesterol (0524A-075)(COMPLETED)
NCT00769132 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate LDL-cholesterol Lowering With Inclisiran Compared to Bempedoic Acid in Patients With Atherosclerotic Cardiovascular Disease.
NCT06431763 ·Status: COMPLETED ·Phase: PHASE4
-
Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemic
NCT06109831 ·Status: COMPLETED ·Phase: PHASE2
-
INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers
NCT03273972 ·Status: COMPLETED ·Phase: NA
-
Lipid Efficacy of the Extended Release Niacin/Laropiprant Combination in Patients With Cardiovascular Disease
NCT01308203 ·Status: TERMINATED ·Phase: PHASE4
-
the Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects in Adult Subjects With Elevated LDL-C
NCT06132360 ·Status: COMPLETED ·Phase: PHASE1
-
Treatment of HDL to Reduce the Incidence of Vascular Events HPS2-THRIVE
NCT00461630 ·Status: COMPLETED ·Phase: PHASE3
-
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia
NCT06723652 ·Status: COMPLETED ·Phase: PHASE3
-
Lp(a) Lowering Study of Pelacarsen (TQJ230) in US Black/African American and Hispanic Participants With Elevated Lp(a) and Established ASCVD
NCT06267560 ·Status: COMPLETED ·Phase: PHASE3