This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Assessment of the Long-Term Safety and Efficacy of Bempedoic Acid (CLEAR Harmony OLE) (NCT03067441), a na phase 3 study. The primary outcome is Number of Participants With Treatment-Emergent Adverse Events (TEAEs).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03067441 |
| Phase | Phase 3 |
| Condition | Hypercholesterolemia, Atherosclerotic Cardiovascular Disease |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 1462 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Esperion Therapeutics, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned people with hypercholesterolemia and atherosclerotic cardiovascular disease. Its brief summary describes participants with high cardiovascular risk and elevated LDL cholesterol that was not adequately controlled by their current therapy. The safety population is defined as all enrolled participants who received at least 1 dose of bempedoic acid in the open-label extension. The registry record reports enrollment of 1462, but the number who received at least 1 dose is not separately stated.
Intervention
Participants received open-label bempedoic acid as a 180 mg tablet. The stated purpose was to assess long-term safety and tolerability, alongside efficacy. The primary endpoint was the number of participants with treatment-emergent adverse events through Week 82. The registry record also lists lipid and inflammatory-marker outcomes at Weeks 52 and 78, including LDL-C, non-HDL-C, total cholesterol, ApoB, Hs-CRP, triglycerides, and HDL-C.
Comparator
There was no randomized comparator in the extension: allocation is listed as not applicable, masking as none, and the model as single-group. The safety record includes groups labelled by treatment history, including participants listed as having received placebo followed by bempedoic acid and participants listed as having received bempedoic acid in both periods. These labels describe different treatment sequences; they do not establish a randomized, concurrent control comparison in the extension.
Primary question
The primary safety question was how many participants experienced a treatment-emergent adverse event. Such events are defined as events that began or worsened in severity after the first dose of investigational medicinal product, through 30 days after the last dose in the extension. This endpoint describes observed events during follow-up; by itself, it does not establish whether an event was caused by treatment. The primary endpoint result is not reported in the registry record. The posted serious-adverse-event counts provide additional safety information, but do not replace the missing primary endpoint result.
3. Trial Design
This was a Phase 3, multicenter, open-label extension study of bempedoic acid, also identified in the official title as ETC-1002 180 MG. Its registered model was single-group, with no allocation and no masking. The record describes one open-label intervention: bempedoic acid 180 mg tablet. Enrollment was 1462. The study status is completed; the recorded start date was 2017-02-03 and primary completion date was 2019-11-05.
An open-label extension follows a parent study and allows continued treatment and observation. The record names the study as CLEAR Harmony OLE and includes safety group labels reflecting treatment sequences: placebo followed by bempedoic acid, bempedoic acid followed by bempedoic acid, and an overall OLE bempedoic acid group. The parent study's design details, eligibility criteria, treatment duration before extension entry, and rules for entering the extension are not reported in the registry record. The cohort labels should not be interpreted as random assignment within this extension.
The primary endpoint was a count of participants with treatment-emergent adverse events, with a timeframe of up to Week 82. Secondary outcomes include changes in several lipid measures and Hs-CRP at Weeks 52 and 78 relative to the parent-study baseline. The registry record lists 17 outcome measures, but does not report an analysis plan or analysis entries. Specific follow-up schedules beyond the listed outcome time points, procedures for maintaining treatment, and criteria for stopping treatment are not reported in the registry record.
Because the study was open-label and single-group, its central statistical role is descriptive follow-up rather than a randomized estimate of treatment effect against a concurrent control. The reported safety counts describe participants in the extension records and should be read in that design context.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: After successfully completing 52 weeks of treatment in the parent study, Study 1002-040 (NCT02666664), and meeting entry criteria, participants could enrol into this Open-label Extension (OLE) study.
Overall Study
| Stage | Placebo; Bempedoic Acid | Bempedoic Acid; Bempedoic Acid |
|---|---|---|
| STARTED | 492 | 970 |
| COMPLETED | 459 | 913 |
| NOT COMPLETED | 33 | 57 |
Reasons for not completing this period:
| Reason | Placebo; Bempedoic Acid | Bempedoic Acid; Bempedoic Acid |
|---|---|---|
| Withdrawal by Subject | 16 | 34 |
| Lost to Follow-up | 7 | 5 |
| Adverse Event | 7 | 14 |
| Study Terminated by Sponsor or Investigator | 1 | 0 |
| Physician Decision | 1 | 3 |
| Other | 1 | 1 |
Analysis population for the primary outcome, as defined in the registry: Safety Population: all enrolled participants who received at least 1 dose of bempedoic acid in the OLE Study
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Baseline data are reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of bempedoic acid in the Open-Label Extension (OLE) Study.
| Characteristic | Unit | Placebo; Bempedoic Acid | Bempedoic Acid; Bempedoic Acid | Total |
|---|---|---|---|---|
| Participants analysed | 492 | 970 | 1462 | |
| Age, Continuous | years | 67.5 (SD 8.54) | 66.5 (SD 8.81) | 66.9 (SD 8.73) |
| Sex: Female, Male: Female | Participants | 142 | 239 | 381 |
| Sex: Female, Male: Male | Participants | 350 | 731 | 1081 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 2 | 2 |
| Race (NIH/OMB): Asian | Participants | 5 | 9 | 14 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Black or African American | Participants | 6 | 23 | 29 |
| Race (NIH/OMB): White | Participants | 480 | 931 | 1411 |
| Race (NIH/OMB): More than one race | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 3 | 4 |
| Low-density lipoprotein cholesterol (LDL-C): Parent Study | milligrams per deciliter (mg/dL) | 98.96 (SD 24.171) | 102.94 (SD 29.899) | 101.60 (SD 28.156) |
| Non-high-density lipoprotein cholesterol (N-HDL-C): Parent Study | mg/dL | 126.41 (SD 28.531) | 130.09 (SD 34.727) | 128.85 (SD 32.809) |
| Total cholesterol: Parent Study | mg/dL | 175.33 (SD 30.026) | 178.94 (SD 36.057) | 177.73 (SD 34.179) |
| Apolipoprotein B: Parent Study | mg/dL | 85.1 (SD 19.25) | 88.2 (SD 21.71) | 87.2 (SD 20.97) |
| High-sensitivity C-reactive protein (hs-CRP): Parent Study | milligrams per Liter (mg/L) | 1.515 (0.810 to 3.490) | 1.500 (0.700 to 3.220) | 1.510 (0.750 to 3.320) |
| Triglycerides: Parent Study | mg/dL | 122.00 (97.50 to 169.25) | 125.00 (97.00 to 164.50) | 124.00 (97.50 to 166.50) |
| High-density lipoprotein cholesterol (HDL-C): Parent Study | mg/dL | 48.93 (SD 11.206) | 48.82 (SD 11.790) | 48.86 (SD 11.593) |
| LDL-C: OLE Study | mg/dL | 99.5 (SD 28.59) | 86.6 (SD 30.18) | 91.0 (SD 30.26) |
| N-HDL-C: OLE Study | mg/dL | 126.1 (SD 32.61) | 113.7 (SD 34.57) | 117.9 (SD 34.42) |
| Total cholesterol: OLE Study | mg/dL | 175.2 (SD 34.23) | 159.8 (SD 36.41) | 165.0 (SD 36.41) |
| Apolipoprotein B: OLE Study | mg/dL | 87.6 (SD 22.74) | 80.4 (SD 21.31) | 82.8 (SD 22.07) |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Treatment-Emergent Adverse Events (TEAEs), measured over Up to Week 82.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint counts participants with treatment-emergent adverse events, abbreviated TEAEs. The registry definition includes events that began or worsened in severity after the first dose of investigational medicinal product and through 30 days after the last dose in the open-label extension. The stated timeframe is up to Week 82, and the defined safety population includes all enrolled participants who received at least 1 dose of bempedoic acid in the extension.
A participant count is a straightforward way to describe how many people experienced at least one qualifying event. It is useful for safety monitoring because it focuses on affected participants rather than treating repeated events in the same participant as separate people. However, the registry record does not report the primary endpoint result, so the number of participants with TEAEs cannot be stated from this record. It also does not provide the event-level detail needed to characterize the number, duration, severity, or clinical course of all TEAEs.
In general, adverse events observed during a study are not automatically caused by the study treatment. A count can describe events during the specified observation period, but causal attribution requires additional clinical and analytical context. The open-label, single-group design also limits comparisons with an untreated or randomized control group. The posted serious-adverse-event counts are a separate safety listing and should not be substituted for the unreported TEAE endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a completed open-label extension with enrollment of 1462 and a primary safety endpoint defined as the number of participants with treatment-emergent adverse events. Although that endpoint is specified, its result is not reported in the registry record. Consequently, the primary endpoint cannot be interpreted as a numerical estimate from this record.
The safety listing reports serious adverse events for treatment-history groups. For the group labelled “Placebo; Bempedoic Acid,” 97 of 492 participants are listed as affected, with 3 deaths. For “Bempedoic Acid; Bempedoic Acid,” 202 of 970 are listed as affected, with 10 deaths. For “OLE Bempedoic Acid,” 299 of 1462 are listed as affected, with 13 deaths. These are counts and denominators as recorded; no comparison or recalculation is needed to describe them. The group labels do not make these randomized comparisons. In particular, the sequence groups should not be read as contemporaneous control and treatment arms within a randomized extension.
The record also lists serious-event terms and percentages: coronary artery disease, 1.5%; atrial fibrillation, 1.2%; pneumonia, 1.2%; angina unstable, 1.0%; angina pectoris, 1.0%; and non-cardiac chest pain, 0.8%. These entries indicate which terms appear among the listed serious events, but the record does not provide additional context about event adjudication, recurrence, duration, or individual participants. The terms alone do not establish treatment causation.
No efficacy results for the listed lipid outcomes are reported in the registry record. The outcomes name changes from the parent-study baseline at Weeks 52 and 78, but the estimates and their precision are not included in the registry record recorded for this analysis. Thus, the record supports a description of study design and selected safety counts, not a numerical assessment of lipid effects or a complete summary of the primary safety outcome.
For general statistical interpretation, a count is most informative when its population, event definition, and observation window are clear. Those definitions are stated for the primary TEAE endpoint, but its observed result is absent. Safety counts may also be influenced by duration of follow-up and participant characteristics; the relevant person-time and detailed follow-up distribution are not reported in the registry record. These limitations matter when interpreting event counts across cohorts or relating them to other studies.
9. Statistical Methods Explained
What does the study design allow?
The registered design is open-label and single-group, with allocation listed as not applicable. In general, random allocation helps balance measured and unmeasured characteristics across treatment groups, supporting a causal comparison. This extension does not provide that randomized comparison. Its safety counts therefore describe events among participants receiving treatment in the extension and among groups distinguished by treatment history; they do not by themselves estimate what would have happened to comparable participants without the extension treatment.
Open-label means participants and study personnel were not masked to treatment assignment. In general, awareness of treatment can affect reporting, clinical decisions, and assessment of events. The registry record does not describe procedures used to reduce such influences. This does not invalidate descriptive counts, but it is relevant when interpreting reported events and when comparing them with results from a masked study.
What is a participant count?
The primary outcome is a count of participants with TEAEs rather than a continuous measurement or a time-to-event estimate. In general, a participant count records whether each person met the event definition during the observation period. It does not disclose how many events each affected participant had. For this endpoint, the registry specifies an event window beginning after the first dose and continuing until 30 days after the last dose, with the outcome timeframe described as up to Week 82.
The outcome is defined for a safety population of enrolled participants who received at least 1 dose in the extension. A clear denominator is important when interpreting a count. Although the overall enrollment is reported as 1462, the number in the defined safety population is not separately reported in the registry record. The primary endpoint count itself is also not reported.
What do the serious-event counts describe?
The registry lists affected participants and participants at risk for the treatment-history groups, as well as deaths. These values are descriptive counts. A count is not an incidence rate: a rate accounts for time at risk, while a simple count does not. In general, differences in follow-up duration can affect the number of observed events, even where groups have similar sizes. Person-time, group-specific follow-up, and a method for adjusting for differing observation time are not reported in the registry record.
The group labels reflect treatment sequences, and the study is not a randomized comparison. General statistical comparisons between groups require attention to how participants entered each group, their baseline characteristics, and the time they were observed. Those details and an inferential analysis are not reported. It would therefore be inappropriate to interpret the group counts as evidence of a treatment difference or to treat them as causal estimates.
What does a confidence interval usually add?
In general, a confidence interval expresses statistical uncertainty around an estimate under a specified analysis model. It helps distinguish the observed estimate from the range of values that remain reasonably compatible with the data and assumptions. The registry record does not report a confidence interval or another precision measure for the primary TEAE endpoint or the serious-event counts. Without such information, the precision of those count summaries cannot be assessed through an interval estimate from this record.
For continuous outcomes such as LDL-C, a mean change and its confidence interval would ordinarily describe both the estimated average change and its uncertainty. The listed secondary outcomes include percent or mean changes from parent-study baseline at Weeks 52 and 78. Their numerical results and uncertainty estimates are not reported in the registry record. No effect size or precision estimate for those outcomes should be inferred from their titles.
What about over-dispersion?
In general, count data can vary more than a simple statistical model expects; this is called over-dispersion. It can arise when some participants have more events than others, or when event risk varies across people or time. A participant-level yes-or-no endpoint and a total event count are not interchangeable: the former counts affected people, while the latter may include repeated events. The primary endpoint is a participant count, and the record does not provide the event-level data or a statistical model needed to assess over-dispersion. No model choice or over-dispersion adjustment is reported in the registry record.
Were inferential analyses specified?
The registry record contains no analysis entries. A statistical analysis plan, hypothesis tests, adjustment strategy, covariate model, and interim analyses are not reported in the registry record. The listed outcome descriptions therefore cannot be treated as evidence that a particular test or model was used. The record's sample-size assumptions describe planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation; these are not stated as the trial's own design justification. No observed-effect estimate or corresponding planning result is reported in the registry record used for this analysis. Such illustrations, where displayed, are planning scenarios and not observed power.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 17 outcome measures, including a primary safety endpoint and secondary outcomes covering lipid measures and Hs-CRP at Weeks 52 and 78. When multiple outcomes or time points are examined, the chance of finding an apparently notable result by chance can increase. In general, a prespecified hierarchy or multiplicity adjustment can help control that risk. The statistical plan, multiplicity strategy, and any prespecified hierarchy are not reported in the registry record. The record contains no analysis entries.
Handling missing outcome data is also important, particularly for follow-up outcomes measured over time. In general, participants may have measurements absent for reasons related to discontinuation, missed visits, or other events; different assumptions about those missing values can produce different estimates. The registry record does not report how missing data were handled, whether imputation was used, or how participants with incomplete follow-up were included in analyses.
The safety population is defined as enrolled participants who received at least 1 dose of bempedoic acid in the extension. Whether the posted serious-event counts use precisely that population for each outcome is not described beyond the listed denominators. The record does not state additional analysis populations or provide a participant flow showing exclusions and follow-up completion. Therefore, the population used for each unreported efficacy analysis cannot be identified. The absence of these details limits assessment of how completely the posted outcome definitions and analysis populations align.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Placebo; Bempedoic Acid | 97 | 492 | 19.7% |
| Bempedoic Acid; Bempedoic Acid | 202 | 970 | 20.8% |
| OLE Bempedoic Acid | 299 | 1462 | 20.5% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Placebo; Bempedoic Acid | 3 of 492 |
| Bempedoic Acid; Bempedoic Acid | 10 of 970 |
| OLE Bempedoic Acid | 13 of 1462 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Placebo; Bempedoic Acid | 108 of 492 |
| Bempedoic Acid; Bempedoic Acid | 201 of 970 |
| OLE Bempedoic Acid | 309 of 1462 |
Most frequent serious adverse event terms
| Event term | Organ system | Placebo; Bempedoic Acid | Bempedoic Acid; Bempedoic Acid | OLE Bempedoic Acid |
|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | 3 of 492 | 15 of 970 | 18 of 1462 |
| Pneumonia | Infections and infestations | 6 of 492 | 9 of 970 | 15 of 1462 |
| Angina pectoris | Cardiac disorders | 5 of 492 | 9 of 970 | 14 of 1462 |
| Atrial fibrillation | Cardiac disorders | 2 of 492 | 12 of 970 | 14 of 1462 |
| Angina unstable | Cardiac disorders | 3 of 492 | 10 of 970 | 13 of 1462 |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | 4 of 492 | 6 of 970 | 10 of 1462 |
| Acute myocardial infarction | Cardiac disorders | 2 of 492 | 7 of 970 | 9 of 1462 |
| Myocardial ischaemia | Cardiac disorders | 3 of 492 | 6 of 970 | 9 of 1462 |
| Non-cardiac chest pain | General disorders | 1 of 492 | 8 of 970 | 9 of 1462 |
| Myocardial infarction | Cardiac disorders | 2 of 492 | 6 of 970 | 8 of 1462 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo; Bempedoic Acid | Bempedoic Acid; Bempedoic Acid | OLE Bempedoic Acid |
|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 33 of 492 | 86 of 970 | 119 of 1462 |
| Urinary tract infection | Infections and infestations | 40 of 492 | 49 of 970 | 89 of 1462 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 30 of 492 | 38 of 970 | 68 of 1462 |
| Upper respiratory tract infection | Infections and infestations | 18 of 492 | 49 of 970 | 67 of 1462 |
Serious events with the highest arm-level rate: coronary artery disease (1.5%), atrial fibrillation (1.2%), pneumonia (1.2%), angina unstable (1.0%), angina pectoris (1.0%).
The serious-adverse-event listing gives affected-participant counts and denominators for three treatment-history labels. The “Placebo; Bempedoic Acid” group reports 97 affected among 492 at risk and 3 deaths. The “Bempedoic Acid; Bempedoic Acid” group reports 202 among 970 and 10 deaths. The “OLE Bempedoic Acid” group reports 299 among 1462 and 13 deaths. These are registry counts, not adjusted comparisons.
The listed serious-event terms include coronary artery disease at 1.5%, atrial fibrillation at 1.2%, pneumonia at 1.2%, angina unstable at 1.0%, angina pectoris at 1.0%, and non-cardiac chest pain at 0.8%. The registry record does not report further detail on event timing, duration, recurrence, adjudication, or causal assessment. These counts and terms should be interpreted as safety observations during the extension, not as proof that treatment caused or prevented an event.
The study was open-label and did not use randomized allocation. Differences between treatment-history groups cannot be interpreted as randomized treatment effects. The primary TEAE endpoint is distinct from this serious-event listing, and its result is not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The study record establishes that an open-label extension of bempedoic acid was completed, with enrollment of 1462, and that the primary safety endpoint was defined as the number of participants with treatment-emergent adverse events through Week 82. It also records serious-adverse-event counts, deaths, and selected serious-event terms. These registry entries describe the study and some observed safety entries.
The record does not report the result for the primary TEAE endpoint, numerical efficacy results for the listed lipid outcomes, or precision estimates for the safety counts. It therefore does not support a complete estimate of the primary safety outcome or a statistical assessment of the listed efficacy outcomes. The absence of a result in the registry record should not be interpreted as a finding of no events or no change.
The design also sets limits on causal conclusions. Open-label treatment and the absence of randomized allocation mean that the treatment-history groups are not like-for-like randomized controls. Observed events may occur during treatment without being caused by it, and counts alone do not account for differences in follow-up or participant characteristics. The record does not supply analyses that address those issues.
In general, a clinical trial result is interpreted by combining the endpoint definition, the observed estimate, its uncertainty, the analysis population, and the study design. Here, the endpoint definition and selected safety counts are available, but the primary endpoint estimate and much of the analytical context are not reported in the registry record. The evidence supports a limited descriptive reading, rather than a conclusion about comparative efficacy or causal safety effects.
13. Why This Trial Matters Statistically
This study illustrates why registry outcome definitions and posted results need to be read separately. A primary endpoint can be clearly described—including its event window and population—while its numerical result is absent. The endpoint title alone is not an estimate, and it cannot answer how many participants experienced the defined events.
The extension also makes the distinction between descriptive safety follow-up and randomized comparison important. Its open-label, single-group design can document events observed during continued treatment, while its treatment-history labels do not create a randomized control group. Statistical interpretation must respect that distinction rather than treating cohort counts as direct comparative effects.
The record's selected serious-event counts and terms are useful descriptive information, but counts do not convey event timing, repeated events, person-time, or uncertainty. The absence of an analysis plan and analysis entries further restricts what can be concluded about efficacy outcomes, missing data, and multiplicity. This is a practical example of how the statistical strength of a registry record depends not only on the size of enrollment, but also on the availability of outcome estimates and methods.
For clinical researchers and biostatisticians, the key lesson is to keep three questions distinct: what was planned, what was observed, and what comparison the design supports. The registry record specifies several outcomes and reports some safety observations, but it does not provide the primary TEAE result or efficacy estimates. A careful account can report those observations without turning them into unsupported treatment-effect claims.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry record does not report the numerical result for the primary TEAE endpoint, despite defining its timeframe and safety population. It also does not report numerical results for the listed secondary lipid and inflammatory-marker outcomes. As a result, the principal safety question and the stated efficacy outcomes cannot be evaluated from the reported results in this record.
The study was open-label and single-group, with allocation listed as not applicable. Its treatment-history groups are not a randomized extension comparison. The record does not describe parent-study eligibility, entry into the extension, baseline characteristics, group-specific follow-up, or participant flow. Without these details, comparability across the displayed groups and completeness of observation cannot be assessed.
For the serious-event counts, the registry record does not provide confidence intervals, adjusted analyses, person-time, detailed event histories, or additional information on causal assessment. It does not report how missing data were handled or specify analysis populations beyond the safety-population definition for the primary endpoint. Statistical analysis methods, multiplicity handling, and interim analyses are not reported in the registry record.
These limitations are specific to the information recorded for this extension. They do not establish that analyses or procedures were absent from the underlying study; they mean that those details are not reported in the registry record. Interpretation should therefore remain descriptive and limited to the design, endpoint definition, and safety counts that are documented.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Assessment of the Long-Term Safety and Efficacy of Bempedoic Acid (CLEAR Harmony OLE) — NCT03067441.
- Registry record last updated 2021-03-01; status last verified 2021-02.
- Results first posted 2020-12-22.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT03067441 is a completed Phase 3, multicenter, open-label extension study of bempedoic acid 180 mg, registered as CLEAR Harmony OLE. The study used a single-group model, with allocation listed as not applicable and masking as none. Enrollment was 1462. The recorded start date was 2017-02-03, and primary completion was 2019-11-05.
The primary endpoint was the number of participants with treatment-emergent adverse events up to Week 82. Its result is not reported in the registry record. The record lists secondary lipid and Hs-CRP outcomes at Weeks 52 and 78, but their numerical results are not reported in the registry record details.
Serious-adverse-event counts and deaths are listed for treatment-history groups, along with selected serious-event terms. These are descriptive observations, not randomized comparisons. Analysis methods, missing-data handling, and multiplicity procedures are not reported in the registry record.