Trial · NCT03067441
Assessment of the Long-Term Safety and Efficacy of Bempedoic Acid (CLEAR Harmony OLE)
NCT03067441, Phase 3, Completed, Esperion Therapeutics, Inc.; results first posted 2020-12-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Assessment of the Long-Term Safety and Efficacy of Bempedoic Acid (CLEAR Harmony OLE). Trials, record NCT03067441. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03067441
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Assessment of the Long-Term Safety and Efficacy of Bempedoic Acid (CLEAR Harmony OLE)
- NCT number
- NCT03067441
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,462 participants, actual
- Lead sponsor
- Esperion Therapeutics, Inc.
- Conditions
- Hypercholesterolemia, Atherosclerotic Cardiovascular Disease
- Interventions
- bempedoic acid
- First posted
- 2017-03-01
- Last updated
- 2021-03-01
- Other registries' IDs
- eudract:2016-004115-12
- Results first posted
- 2020-12-22
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Up to Week 82 | TEAEs are defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) Study. |
| Secondary | Percent Change From Parent Study Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Weeks 52 and 78 | Baseline; Week 52 and Week 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: LDL-C value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study. |
| Secondary | Mean Change From Parent Study Baseline in LDL-C at Weeks 52 and 78 | Baseline; Week 52 and Week 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Mean change from Baseline was calculated as: Mean LDL-C value at Week 52/Week 78 minus Mean Parent Study Baseline value. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study. |
| Secondary | Percent Change From Parent Study Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 52 and 78 | Baseline; Week 52 and Week 72 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: non-HDL-C value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study. |
| Secondary | Percent Change From Parent Study Baseline in Total Cholesterol at Weeks 52 and 78 | Baseline; Week 52 and Week 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: Total cholesterol value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study. |
| Secondary | Percent Change From Parent Study Baseline in Apolipoprotein B (ApoB) at Weeks 52 and 78 | Baseline; Week 52 and Week 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: ApoB value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study. |
| Secondary | Percent Change From Parent Study Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Weeks 52 and 78 | Baseline; Week 52 and Week 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: hs-CRP value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study. |
| Secondary | Percent Change From Parent Study Baseline in Triglycerides at Weeks 52 and 78 | Baseline; Week 52 and Week 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: Triglycerides value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study. |
| Secondary | Percent Change From Parent Study Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Weeks 52 and 78 | Baseline; Week 52 and Week 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: HDL-C value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study. |
| Secondary | Percent Change From Open-Label Extension (OLE) Study Baseline in LDL-C at Weeks 52 and 78 | Baseline; Week 52 and Week 78 | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: LDL-C value at Week 52/Week 78 minus OLE Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Up to Week 82 | Safety Population: all enrolled participants who received at least 1 dose of bempedoic acid in the OLE Study | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change From Parent Study Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Weeks 52 and 78 | Baseline; Week 52 and Week 78 | Safety Population. Only participants with available data were analyzed. | percent change | MEAN |
| SECONDARY | Mean Change From Parent Study Baseline in LDL-C at Weeks 52 and 78 | Baseline; Week 52 and Week 78 | Safety Population. Only participants with available data were analyzed. | milligrams per deciliter (mg/dL) | MEAN |
| SECONDARY | Percent Change From Parent Study Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 52 and 78 | Baseline; Week 52 and Week 72 | Safety Population. Only participants with available data were analyzed. | percent change | MEAN |
| SECONDARY | Percent Change From Parent Study Baseline in Total Cholesterol at Weeks 52 and 78 | Baseline; Week 52 and Week 78 | Safety Population. Only participants with available data were analyzed. | percent change | MEAN |
| SECONDARY | Percent Change From Parent Study Baseline in Apolipoprotein B (ApoB) at Weeks 52 and 78 | Baseline; Week 52 and Week 78 | Safety Population. Only participants with available data were analyzed. | percent change | MEAN |
| SECONDARY | Percent Change From Parent Study Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Weeks 52 and 78 | Baseline; Week 52 and Week 78 | Safety Population. Only participants with available data were analyzed. | percent change | MEDIAN |
| SECONDARY | Percent Change From Parent Study Baseline in Triglycerides at Weeks 52 and 78 | Baseline; Week 52 and Week 78 | Safety Population. Only participants with available data were analyzed. | percent change | MEDIAN |
| SECONDARY | Percent Change From Parent Study Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Weeks 52 and 78 | Baseline; Week 52 and Week 78 | Safety Population. Only participants with available data were analyzed. | percent change | MEAN |
| SECONDARY | Percent Change From Open-Label Extension (OLE) Study Baseline in LDL-C at Weeks 52 and 78 | Baseline; Week 52 and Week 78 | Safety Population. Only participants with available data were analyzed. | percent change | MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group111
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Placebo; Bempedoic Acid | Participants with TEAEs | 385 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Bempedoic Acid; Bempedoic Acid | Participants with TEAEs | 758 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | OLE Bempedoic Acid | Participants with TEAEs | 1143 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Placebo; Bempedoic Acid | Participants with serious TEAEs | 97 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Bempedoic Acid; Bempedoic Acid | Participants with serious TEAEs | 202 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | OLE Bempedoic Acid | Participants with serious TEAEs | 299 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Placebo; Bempedoic Acid | Participants with TEAEs of mild severity | 93 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Bempedoic Acid; Bempedoic Acid | Participants with TEAEs of mild severity | 195 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | OLE Bempedoic Acid | Participants with TEAEs of mild severity | 288 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Placebo; Bempedoic Acid | Participants with TEAEs of moderate severity | 211 | Participants |
1 to 10 of 111Source ClinicalTrials.gov
See all 111 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; Bempedoic Acid | 492 | |
| Overall Study | STARTED | Bempedoic Acid; Bempedoic Acid | 970 | |
| Overall Study | COMPLETED | Placebo; Bempedoic Acid | 459 | |
| Overall Study | COMPLETED | Bempedoic Acid; Bempedoic Acid | 913 | |
| Overall Study | NOT COMPLETED | Placebo; Bempedoic Acid | 33 | |
| Overall Study | NOT COMPLETED | Bempedoic Acid; Bempedoic Acid | 57 |
Source ClinicalTrials.gov
Adverse events669
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 | Nasopharyngitis | Infections and infestations | Placebo; Bempedoic Acid | 33 | 492 | |
| other | Nasopharyngitis | Infections and infestations | Bempedoic Acid; Bempedoic Acid | 86 | 970 | |
| other | Nasopharyngitis | Infections and infestations | OLE Bempedoic Acid | 119 | 1,462 | |
| other | Urinary tract infection | Infections and infestations | Placebo; Bempedoic Acid | 40 | 492 | |
| other | Urinary tract infection | Infections and infestations | Bempedoic Acid; Bempedoic Acid | 49 | 970 | |
| other | Urinary tract infection | Infections and infestations | OLE Bempedoic Acid | 89 | 1,462 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo; Bempedoic Acid | 30 | 492 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Bempedoic Acid; Bempedoic Acid | 38 | 970 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | OLE Bempedoic Acid | 68 | 1,462 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo; Bempedoic Acid | 18 | 492 |
1 to 10 of 669Source ClinicalTrials.gov
See all 669 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo; Bempedoic Acid | 3 | 492 |
| Total, all-cause mortality | Bempedoic Acid; Bempedoic Acid | 10 | 970 |
| Total, all-cause mortality | OLE Bempedoic Acid | 13 | 1,462 |
| Total, other adverse events | Placebo; Bempedoic Acid | 108 | 492 |
| Total, other adverse events | Bempedoic Acid; Bempedoic Acid | 201 | 970 |
| Total, other adverse events | OLE Bempedoic Acid | 309 | 1,462 |
| Total, serious adverse events | Placebo; Bempedoic Acid | 97 | 492 |
| Total, serious adverse events | Bempedoic Acid; Bempedoic Acid | 202 | 970 |
| Total, serious adverse events | OLE Bempedoic Acid | 299 | 1,462 |
Source ClinicalTrials.gov
Papers5
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
GET https://conductscience.org/api/trials/v1/NCT03067441
GET https://conductscience.org/api/trials/v1/NCT03067441/results?page=2