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)
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol, Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/31/2019 |
| Start Date: | November 29, 2016 |
| End Date: | February 12, 2018 |
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Bempedoic Acid (ETC 1002) 180 mg/Day as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C
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.
therapy is effective and safe versus placebo in patients with elevated LDL cholesterol.
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.
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