Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg, Ezetimibe 10mg, and Atorvastatin 20 mg Triplet Therapy in Patients With Elevated LDL-C
Part of paid clinical trials in Champaign, Illinois.
- Sponsor
- Esperion Therapeutics, Inc.
- Study ID
- NCT03051100
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Bempedoic acid 180mg — DRUGbempedoic acid 180 mg
- Ezetimibe 10mg — DRUGezetimibe 10 mg
- Atorvastatin 20mg — DRUGatorvastatin 20 mg
- Placebo — OTHERplacebo
Study Details
The purpose of this study is to determine if triplet therapy with bempedoic acid (ETC-1002) 180mg, ezetimibe 10mg, and atorvastatin 20mg is effective and safe versus placebo in patients with elevated LDL cholesterol.
Key Dates
- Start date
- Jan 19, 2017
- Status verified
- Mar 2020
- Primary completion
- Jun 1, 2017
- Completion
- Jul 5, 2017
Study Design
- Enrollment
- 63 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Triplet TherapyBempedoic acid 180 mg, ezetimibe 10 mg, and atorvastatin 20 mg taken orally, daily.
- Placebo Comparator: placeboMatching placebos taken orally, daily.
Primary Outcome Measure
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 6 [ Time Frame: Baseline; Week 6 ]
Locations (11)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| PMG Research of Christie Clinic | Champaign | Illinois | 61820 | - |
| PMG Research of Cary | Cary | North Carolina | 27518 | - |
| PMG Research of Charlotte | Charlotte | North Carolina | 28209 | - |
| Sensenbrenner Primary Care | Charlotte | North Carolina | 28277 | - |
| PMG Research of Hickory | Hickory | North Carolina | 28601 | - |
| PMG Research of Raleigh | Raleigh | North Carolina | 27609 | - |
| PMG Research of Rocky Mount | Rocky Mount | North Carolina | 27804 | - |
| PMG Research Salisbury | Salisbury | North Carolina | 28144 | - |
| PMG Research of Wilmington | Wilmington | North Carolina | 28401 | - |
| PMG Research of Charleston | Mt. Pleasant | South Carolina | 29464 | - |
| Hampton Roads Center for Clinical Research | Virginia Beach | Virginia | 23451 | - |
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