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NCT03337308 · ClinicalTrials.gov registry record · Phase 3
A Study Evaluating the Safety and Efficacy of Bempedoic Acid Plus Ezetimibe Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo in Patients Treated With Maximally Tolerated Statin Therapy
A Phase 3 study, sponsored by Esperion Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 382
- Enrollment target
NCT03337308: Completed Phase 3 study, sponsored by Esperion Therapeutics.
NCT03337308 is a Phase 3 study that has completed, run by Esperion Therapeutics. The registered enrollment target is 382 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03337308, a Phase 3 study, has completed, sponsored by Esperion Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 382 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if Bempedoic Acid (BA) + Ezetimibe (EZE) in a fixed-dose combination (FDC) is effective and safe versus its individual components and placebo in patients with elevated LDL cholesterol treated with maximally tolerated statin therapy.
Primary Outcome
Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the mean of the LDL-C values from Week -2 and predose Day 1/Week 0. Percent change from baseline in LDL-C was analyzed using analysis of covariance (ANCOVA) with treatment group and randomization stratification as a factors and baseline LDL-C as a covariate. Percent change from baseline was calculated as: (\[LDL-C value at We
Interventions
- DRUG Placebos
- DRUG Bempedoic Acid
- DRUG Ezetimibe
- COMBINATION_PRODUCT Bempedoic Acid + Ezetimibe Fixed-Dose Combination
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 382 participants |
| Start Date | 2017-10-23 |
| Est. Completion | 2018-07-18 |
| Phase | Phase 3 |
What the finished NCT03337308 record still lists
NCT03337308 is an interventional study that assigns participants to a tested intervention. The registered 382 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebos is the first listed.
NCT03337308 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03337308 about?
NCT03337308 is a clinical study titled "A Study Evaluating the Safety and Efficacy of Bempedoic Acid Plus Ezetimibe Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo in Patients Treated With Maximally Tolerated Statin Therapy". The purpose of this study is to determine if Bempedoic Acid (BA) + Ezetimibe (EZE) in a fixed-dose combination (FDC) is effective and safe versus its individual components and placebo in patients with elevated LDL cholesterol treated with maximally tolerated statin therapy.
What is the current status of trial NCT03337308?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 382 participants. The study started on 2017-10-23. Estimated completion is 2018-07-18.
What interventions are being tested in trial NCT03337308?
The interventions under investigation include: Placebos (DRUG), Bempedoic Acid (DRUG), Ezetimibe (DRUG), Bempedoic Acid + Ezetimibe Fixed-Dose Combination (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03337308?
This trial is sponsored by Esperion Therapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03337308's enrollment target sits among peer trials
382 978th of 2000 higher than 1,019 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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