Trial · NCT03001076
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)
NCT03001076, Phase 3, Completed, Esperion Therapeutics, Inc.; results first posted 2020-04-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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). Trials, record NCT03001076. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03001076
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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)
- NCT number
- NCT03001076
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 269 participants, actual
- Lead sponsor
- Esperion Therapeutics, Inc.
- Conditions
- Hypercholesterolemia, Atherosclerosis, Statin Adverse Reaction
- Interventions
- Bempedoic acid, Ezetimibe, Placebo
- First posted
- 2016-12-22
- Last updated
- 2020-05-11
- Results first posted
- 2020-04-03
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C) | Week 12 | 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 the last two non-missing values on or prior to Day 1. Percent change from baseline was calculated as: (\[LDL-C value at Week 12 minus Baseline value\] divided by \[Baseline Value\]) multiplied by 100. Bempedoic Acid = BA. Percent change from Baseline in LDL-C was analyzed using an analysis of covariance (ANCOVA) model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate. In the ANCOVA model, missing LDL-C data at Week 12 were imputed using multiple imputation method taking into account adherence to treatment. |
| Secondary | Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 12 | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analysed for non-HDL-C. Baseline was defined as the mean of the non-HDL-C values from the last two non-missing values on or prior to Day 1. Percent change from baseline was calculated as: (\[non-HDL-C value at Week 12 minus Baseline value\] divided by \[Baseline Value\]) multiplied by 100. Percent change from Baseline in non-HDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate. In the ANCOVA model, missing non-HDL-C data at Week 12 were imputed using multiple imputation method taking into account adherence to treatment. |
| Secondary | Percent Change From Baseline to Week 12 in Total Cholesterol (TC) | Week 12 | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analysed for TC. Baseline was defined as the mean of the TC values from the last two non-missing values on or prior to Day 1. Percent change from baseline was calculated as: (\[TC value at Week 12 minus Baseline value\] divided by \[Baseline Value\]) multiplied by 100. Percent change from Baseline in TC was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate. In the ANCOVA model, missing TC data at Week 12 were imputed using multiple imputation method taking into account adherence to treatment. |
| Secondary | Percent Change From Baseline to Week 12 in Apolipoprotein B (apoB) | Week 12 | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analysed for apoB. Baseline was defined as the last non-missing value on or prior to Day 1. Percent change from baseline was calculated as: \[(apoB value at Week 12 minus Baseline value) divided by (Baseline Value)\] multiplied by 100. Percent change from Baseline in apoB was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate. In the ANCOVA model, missing apoB data at Week 12 were imputed using multiple imputation method taking into account adherence to treatment. |
| Secondary | Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP) | Week 12 | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analysed for hsCRP. Baseline was defined as the last non-missing value on or prior to Day 1. Percent change from baseline was calculated as: \[(hsCRP value at Week 12 minus Baseline value) divided by (Baseline Value)\] multiplied by 100. |
| Secondary | Percent Change From Baseline to Week 12 in Triglycerides (TGs) | Week 12 | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for TGs. Baseline was defined as the mean of the TGs values from the last two non-missing values on or prior to D 1. Percent change from baseline was calculated as: \[(TGs value at Week 12 minus Baseline value) divided by (Baseline Value)\] multiplied by 100. Percent change from Baseline in TGs was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate. |
| Secondary | Percent Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (HDL-C) | Week 12 | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for HDL-C. Baseline was defined as the mean of the HDL-C values from the last two non-missing values on or prior to Day 1. Percent change from baseline was calculated as: \[(HDL-C value at Week 12 minus Baseline value) divided by (Baseline Value)\] multiplied by 100. Percent change from Baseline in HDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to approximately 16 weeks | TEAEs, defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported. |
| Other | Percent Change From Baseline to Weeks 4 and 8 in LDL-C | Week 4 and Week 8 | 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 the last two non-missing values on or prior to Day 1. Percent change from baseline was calculated as: \[(LDL-C value at Week 4 or 8 minus Baseline value) divided by (Baseline Value)\] multiplied by 100. Percent change from Baseline in LDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate. |
| Other | Percent Change From Baseline to Weeks 4 and 8 in Non-HDL-C | Week 4 and Week 8 | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for Non-HDL-C. Baseline was defined as the mean of the Non-HDL-C values from the last two non-missing values on or prior to Day 1. Percent change from baseline was calculated as: \[(Non-HDL-C value at Week 4 or 8 minus Baseline value) divided by (Baseline Value)\] multiplied by 100. Percent change from Baseline in non-HDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C) | Week 12 | Full Analysis Set: all randomized participants | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Week 12 | Full Analysis Set | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline to Week 12 in Total Cholesterol (TC) | Week 12 | Full Analysis Set | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline to Week 12 in Apolipoprotein B (apoB) | Week 12 | Full Analysis Set | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP) | Week 12 | Full Analysis Set. Only participants with available data were analyzed. | Percent change | MEDIAN |
| SECONDARY | Percent Change From Baseline to Week 12 in Triglycerides (TGs) | Week 12 | Full Analysis Set. Only participants with available data were analyzed. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (HDL-C) | Week 12 | Full Analysis Set. Only participants with available data were analyzed. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to approximately 16 weeks | Safety Analysis Set: all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group that they actually received, regardless of their randomized treatment. | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Percent Change From Baseline to Weeks 4 and 8 in LDL-C | Week 4 and Week 8 | Full Analysis Set. Only participants with available data were analyzed. | Percent change | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Percent Change From Baseline to Weeks 4 and 8 in Non-HDL-C | Week 4 and Week 8 | Full Analysis Set. Only participants with available data were analyzed. | Percent change | LEAST_SQUARES_MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C) | Placebo | 4.99 | Standard Error 2.299 | percent change | |
| Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C) | Bempedoic Acid | -23.46 | Standard Error 1.945 | percent change | |
| Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Placebo | 5.19 | Standard Error 2.202 | percent change | |
| Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Bempedoic Acid | -18.38 | Standard Error 1.668 | percent change | |
| Percent Change From Baseline to Week 12 in Total Cholesterol (TC) | Placebo | 2.88 | Standard Error 1.553 | Percent change | |
| Percent Change From Baseline to Week 12 in Total Cholesterol (TC) | Bempedoic Acid | -15.11 | Standard Error 1.282 | Percent change | |
| Percent Change From Baseline to Week 12 in Apolipoprotein B (apoB) | Placebo | 4.74 | Standard Error 1.786 | Percent change | |
| Percent Change From Baseline to Week 12 in Apolipoprotein B (apoB) | Bempedoic Acid | -14.58 | Standard Error 1.497 | Percent change | |
| Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP) | Placebo | 2.088 | Inter-Quartile Range -32.143 to 49.224 | Percent change | |
| Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP) | Bempedoic Acid | -32.521 | Inter-Quartile Range -55.556 to 10.714 | Percent change |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 88 | |
| Overall Study | STARTED | Bempedoic Acid | 181 | |
| Overall Study | COMPLETED | Placebo | 81 | |
| Overall Study | COMPLETED | Bempedoic Acid | 176 | |
| Overall Study | NOT COMPLETED | Placebo | 7 | |
| Overall Study | NOT COMPLETED | Bempedoic Acid | 5 |
Source ClinicalTrials.gov
Adverse events48
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vertigo | Ear and labyrinth disorders | Placebo | 2 | 87 | |
| other | Vertigo | Ear and labyrinth disorders | Bempedoic Acid | 0 | 181 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 0 | 87 | |
| other | Nausea | Gastrointestinal disorders | Bempedoic Acid | 5 | 181 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 1 | 87 | |
| other | Nasopharyngitis | Infections and infestations | Bempedoic Acid | 4 | 181 | |
| other | Urinary tract infection | Infections and infestations | Placebo | 5 | 87 | |
| other | Urinary tract infection | Infections and infestations | Bempedoic Acid | 5 | 181 | |
| other | Sinusitis | Infections and infestations | Placebo | 0 | 87 | |
| other | Sinusitis | Infections and infestations | Bempedoic Acid | 5 | 181 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 87 |
| Total, all-cause mortality | Bempedoic Acid | 0 | 181 |
| Total, other adverse events | Placebo | 18 | 87 |
| Total, other adverse events | Bempedoic Acid | 46 | 181 |
| Total, serious adverse events | Placebo | 3 | 87 |
| Total, serious adverse events | Bempedoic Acid | 5 | 181 |
Source ClinicalTrials.gov
Papers8
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Bempedoic Acid vs Placebo: deaths from any cause | Trial comparisons |
| Bempedoic Acid vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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