Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) as Add-on to Ezetimibe Therapy… (NCT03001076) | Clinical Trial Compass
CompletedPhase 3
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)
United States269 participantsStarted 2016-11-29
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C)