Phase 3
Completed N=269
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C (CLEAR Tranquility)
Hypercholesterolemia · Atherosclerosis · Statin Adverse Reaction
Source: ClinicalTrials.gov NCT03001076 ↗
Enrolled (actual)
269
Serious AEs
3.0%
Results posted
Apr 2020
Primary outcomePrimary: Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C) — 4.99; -23.46 percent change — p=<0.001
◆ Published Evidence
Highly cited
421citations · ~53 / year
Efficacy and safety of bempedoic acid added to ezetimibe in statin-intolerant patients with hypercholesterolemia: A randomized, placebo-controlled study.
Summary
The purpose of this study is to determine if bempedoic acid (ETC-1002) added-on to ezetimibe therapy is effective and safe versus placebo in patients with elevated LDL cholesterol.
Linked Publications (3)
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Efficacy and safety of bempedoic acid added to ezetimibe in statin-intolerant patients with hypercholesterolemia: A randomized, placebo-controlled study.
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Association of Bempedoic Acid Administration With Atherogenic Lipid Levels in Phase 3 Randomized Clinical Trials of Patients With Hypercholesterolemia.
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Factors Associated With Enhanced Low-Density Lipoprotein Cholesterol Lowering With Bempedoic Acid.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C) |
4.99; -23.46 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) |
5.19; -18.38 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 12 in Total Cholesterol (TC) |
2.88; -15.11 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 12 in Apolipoprotein B (apoB) |
4.74; -14.58 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP) |
2.088; -32.521 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 12 in Triglycerides (TGs) |
9.23; 4.70 | =0.388 |
| SECONDARY Percent Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (HDL-C) |
-1.38; -7.27 | =0.002 sig |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
39; 88; 18; 46; 3; 5 | — |
Eligibility Criteria
Inclusion Criteria
- Fasting LDL-cholesterol greater than or equal to 100 mg/dL at screening
- Men and nonpregnant, nonlactating women
- Use of stable lipid-modifying therapy for at least 4 weeks prior to screening that includes ezetimibe 10mg daily
Exclusion Criteria
- Fasting blood triglycerides greater than or equal to 500 mg/dL
- Body Mass Index (BMI) greater than or equal to 50 kg/m2
- Recent history of clinically significant cardiovascular disease
- Use of statin therapy where doses are greater than those defined as "low-dose" within 4 weeks prior to screening; where "low-dose" is defined as an average daily dose of rosuvastatin 5 mg, atorvastatin 10 mg, simvastatin 10 mg, lovastatin 20 mg, pravastatin 40 mg, fluvastatin 40 mg, or pitavastatin 2 mg.
Data sourced from ClinicalTrials.gov (NCT03001076) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.