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NCT03051100 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Hypercholesterolemia, sponsored by Esperion Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
- 11
- Study locations
NCT03051100: Completed Phase 2 study of Hypercholesterolemia, sponsored by Esperion Therapeutics.
NCT03051100 is a Phase 2 study of Hypercholesterolemia that has completed, run by Esperion Therapeutics. The registered enrollment target is 63 participants, below the 816-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (92% lower). The trial reports 11 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03051100, a Phase 2 study of Hypercholesterolemia, has completed, sponsored by Esperion Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
- 11
- Study locations
Study Summary
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.
Primary Outcome
Percent change from Baseline is calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value ) x 100. Baseline is defined as the mean of the values from Week -1 (Screening Visit 2) and predose Day 1/Week 0 (Treatment Visit 1). Percent change from Baseline in LDL-C was analyzed using analysis of covariance (ANCOVA) with treatment group as a factor and Baseline value as a covariate. Missing LDL-C values were imputed using last observation carried forward (LOCF)
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Atorvastatin 20mg
- DRUG Bempedoic acid 180mg
- DRUG Ezetimibe 10mg
Study Locations (11)
North Carolina
- PMG Research of Cary - Cary
- PMG Research of Charlotte - Charlotte
- Sensenbrenner Primary Care - Charlotte
- PMG Research of Hickory - Hickory
- PMG Research of Raleigh - Raleigh
- PMG Research of Rocky Mount - Rocky Mount
- PMG Research Salisbury - Salisbury
- PMG Research of Wilmington - Wilmington
Illinois
- PMG Research of Christie Clinic - Champaign
South Carolina
- PMG Research of Charleston - Mt. Pleasant
Virginia
- Hampton Roads Center for Clinical Research - Virginia Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2017-01-19 |
| Est. Completion | 2017-07-05 |
| Phase | Phase 2 |
What the finished NCT03051100 record still lists
NCT03051100 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 816-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Hypercholesterolemia appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT03051100 lists 11 locations in 4 states (North Carolina, Illinois, South Carolina).
Frequently Asked Questions
What is clinical trial NCT03051100 about?
NCT03051100 is a clinical study titled "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". 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.
What is the current status of trial NCT03051100?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2017-01-19. Estimated completion is 2017-07-05.
What conditions does trial NCT03051100 study?
This clinical trial studies the following conditions: Hypercholesterolemia.
What interventions are being tested in trial NCT03051100?
The interventions under investigation include: Placebo (OTHER), Atorvastatin 20mg (DRUG), Bempedoic acid 180mg (DRUG), Ezetimibe 10mg (DRUG).
Who is sponsoring clinical trial NCT03051100?
This trial is sponsored by Esperion Therapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03051100 being conducted?
This trial has 11 study locations across Illinois, North Carolina, South Carolina, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03051100's enrollment target sits among peer trials
63 49th of 62 higher than 14 of 62 other Hypercholesterolemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypercholesterolemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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