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 Evaluation of Long-Term Safety and Tolerability of ETC-1002 in High-Risk Patients With Hyperlipidemia and High CV Risk (CLEAR Harmony) (NCT02666664), a randomized phase 3 study. The primary outcome is Percentage of Participants With Treatment-emergent Adverse Events (TEAEs).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02666664 |
| Phase | Phase 3 |
| Condition | Hypercholesterolemia, Atherosclerotic Cardiovascular Diseases |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 2230 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Esperion Therapeutics, Inc. |
| Results posted | Yes |
2. Clinical Question
The trial asked whether ETC-1002 was safe and well-tolerated compared with placebo in patients with high cardiovascular risk and elevated LDL cholesterol that was not adequately controlled by their current lipid-modifying therapy. Its primary endpoint was the percentage of participants with treatment-emergent adverse events (TEAEs), collected for up to approximately 52 weeks.
Population
Patients with hyperlipidemia at high cardiovascular risk whose LDL cholesterol was not adequately controlled by their lipid-modifying therapy. The registry record identifies hypercholesterolemia and atherosclerotic cardiovascular diseases as conditions.
Intervention
ETC-1002, identified in the registry record as bempedoic acid, at 180 mg/day.
Comparator
Placebo control.
Primary question
What percentage of participants experienced a TEAE during the collection period, and how did the posted safety information compare between the ETC-1002 and placebo groups?
The endpoint definition included adverse events that began or worsened in severity after the first dose of double-blind study drug and up to 30 days after the last dose. The registry record identifies a safety population comprising randomized participants who received at least 1 dose of investigational medicinal product. It says participants were included in the group they received, regardless of randomized treatment.
The registry record does not report an aggregate result for the primary endpoint in a form that supports a single comparison. It notes that the primary outcome has several categories or time points and was not reduced to one comparison. Therefore, the clinical question can be described from the protocol record, but an overall numerical estimate for the primary comparison cannot be stated from the posted primary outcome information.
3. Trial Design
CLEAR Harmony, registered as NCT02666664, was a randomized, triple-masked, parallel-group phase 3 study. It compared ETC-1002 with placebo in a multicenter setting. The official title describes a long-term safety and tolerability study in patients with hyperlipidemia at high cardiovascular risk who were not adequately controlled by lipid-modifying therapy.
The registry record lists enrollment of 2230. The study began on 2016-01-21, had a primary completion date of 2018-02-21, and is recorded as completed. The planned intervention was ETC-1002 180 mg/day; the comparator was placebo. The record identifies Esperion Therapeutics, Inc. as sponsor.
Randomization assigns participants to treatment groups by chance, which is intended to reduce systematic differences between groups at the start of a trial. In a parallel-group design, participants remain in their assigned study groups rather than crossing between treatments. Masking is intended to limit the influence of knowledge about treatment assignment on participant experience, clinical care, and assessment. The registry record labels masking as triple but does not describe which groups of people were masked.
The primary endpoint was safety-focused: the percentage of participants with TEAEs, collected for up to approximately 52 weeks. The listed safety population included randomized participants who received at least 1 dose, with participants categorized by the treatment they received rather than necessarily by randomized assignment. This definition is relevant when interpreting group counts: it describes the population used for the reported safety outcome, not necessarily every randomized participant.
The registry record also lists secondary outcomes for percent change and absolute change from baseline to Week 12 in LDL-C. It reports 30 outcome measures and 8 analyses. The record does not report the rationale for the enrollment target, detailed allocation procedures, or the full analysis plan. Those details should not be inferred from the trial’s design labels or enrollment count.
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: The study consisted of 2 periods: a 2-week screening period and a 52-week double-blind, randomized treatment period.
Overall Study
| Stage | Placebo | Bempedoic Acid |
|---|---|---|
| STARTED | 742 | 1488 |
| COMPLETED | 706 | 1404 |
| NOT COMPLETED | 36 | 84 |
Reasons for not completing this period:
| Reason | Placebo | Bempedoic Acid |
|---|---|---|
| Physician Decision | 0 | 1 |
| Protocol Violation | 0 | 2 |
| Other | 0 | 1 |
| Adverse Event | 12 | 37 |
| Withdrawal by participant | 23 | 40 |
| Sponsor decision | 0 | 1 |
| Lost to Follow-up | 1 | 2 |
Analysis population for the primary outcome, as defined in the registry: Safety Population: all randomized participants who received at least 1 dose of investigational medicinal product. Participants were included in the treatment group that they received, regardless of their randomized treatment.
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.
| Characteristic | Unit | Placebo | Bempedoic Acid | Total |
|---|---|---|---|---|
| Participants analysed | 742 | 1488 | 2230 | |
| Age, Continuous | years | 66.8 (SD 8.64) | 65.8 (SD 9.11) | 66.1 (SD 8.96) |
| Sex: Female, Male: Female | Participants | 213 | 389 | 602 |
| Sex: Female, Male: Male | Participants | 529 | 1099 | 1628 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 11 | 24 | 35 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 731 | 1464 | 2195 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 | 2 | 3 |
| Race (NIH/OMB): Asian | Participants | 8 | 14 | 22 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 2 | 2 |
| Race (NIH/OMB): Black or African American | Participants | 15 | 42 | 57 |
| Race (NIH/OMB): White | Participants | 716 | 1423 | 2139 |
| Race (NIH/OMB): More than one race | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 2 | 4 | 6 |
| Cardiovascular history: atherosclerotic cardiovascular disease (ASCVD): Yes | Participants | 727 | 1449 | 2176 |
| Cardiovascular history: atherosclerotic cardiovascular disease (ASCVD): No | Participants | 15 | 39 | 54 |
| Cardiovascular history: heterozygous familial hypercholesterolemia (HeFH): Yes | Participants | 23 | 56 | 79 |
| Cardiovascular history: heterozygous familial hypercholesterolemia (HeFH): No | Participants | 719 | 1432 | 2151 |
| History of diabetes: Yes | Participants | 212 | 425 | 637 |
| History of diabetes: No | Participants | 530 | 1063 | 1593 |
| History of hypertension: Yes | Participants | 594 | 1174 | 1768 |
| History of hypertension: No | Participants | 148 | 314 | 462 |
| Concomitant lipid-modifying therapy (LMT): Statin: Yes | Participants | 742 | 1485 | 2227 |
| Concomitant lipid-modifying therapy (LMT): Statin: No | Participants | 0 | 3 | 3 |
| Concomitant LMT: Ezetimibe: Yes | Participants | 56 | 116 | 172 |
| Concomitant LMT: Ezetimibe: No | Participants | 686 | 1372 | 2058 |
| Concomitant LMT: Fibrate: Yes | Participants | 26 | 54 | 80 |
| Concomitant LMT: Fibrate: No | Participants | 716 | 1434 | 2150 |
| Concomitant LMT: None: Concomitant LMT: None | Participants | 0 | 2 | 2 |
| Concomitant LMT: None: Concomitant LMT: Yes | Participants | 742 | 1486 | 2228 |
| Baseline statin intensity: Low | Participants | 48 | 100 | 148 |
| Baseline statin intensity: Moderate | Participants | 324 | 646 | 970 |
| Baseline statin intensity: High | Participants | 370 | 742 | 1112 |
| Estimated glomerular filtration rate (eGFR): Normal: ≥ 90 mL/min/1.73m^2 | Participants | 167 | 320 | 487 |
| Estimated glomerular filtration rate (eGFR): Mild Renal Impairment: 60-89 mL/min/1.73m^2 | Participants | 468 | 946 | 1414 |
| Estimated glomerular filtration rate (eGFR): Moderate Renal Impairment: 30-59 mL/min/1.73m^2 | Participants | 107 | 222 | 329 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), measured over Up to approximately 52 weeks.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percentage of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint was the percentage of participants with treatment-emergent adverse events. A TEAE was defined as an adverse event that began, or worsened in severity, after the first dose of double-blind study drug and through 30 days after the last dose. The collection period was up to approximately 52 weeks. The registry record specifies the safety population as randomized participants who received at least 1 dose of investigational medicinal product, grouped according to the treatment they received.
This type of endpoint is used to describe how often participants experience events during treatment and the specified follow-up window. General statistical context: a percentage expresses the number of participants with at least one event relative to the number in the analysis population. It does not, by itself, describe event severity, duration, recurrence, or whether an event was caused by study treatment. Those questions require additional definitions and analyses.
The posted primary outcome information is not presented as one overall comparison. The registry record notes that the primary outcome has several categories or time points and was not reduced to one comparison. As a result, the aggregate TEAE percentage for each group and a comparative estimate are not reported in the registry record in the available primary outcome entry. The endpoint definition is clear, but the result cannot be summarized as a single numerical treatment contrast from that entry.
The registry record separately lists LDL-C outcomes at Week 12. These are secondary outcomes and address changes in a laboratory measure, rather than the primary safety endpoint. The registry record does not report the numerical findings for those outcomes in the registry record for this analysis.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The trial’s main question concerned the frequency of treatment-emergent adverse events during a collection period of up to approximately 52 weeks. The registry record defines the event window and safety population, but its primary outcome entry is not a single aggregate comparison. It explicitly notes that the primary outcome has several categories or time points and was not reduced to one comparison. Consequently, a group-level overall TEAE percentage, treatment contrast, confidence interval, or test result for the primary endpoint is not reported in the registry record.
The safety information does include serious adverse event counts. For the Bempedoic Acid group, the registry record lists 216 participants with serious adverse events among 1487 at risk. For placebo, it lists 104 participants with serious adverse events among 742 at risk. These are posted counts and denominators, not adjusted comparisons. No confidence intervals or inferential test results for this comparison are reported in the registry record. The counts therefore describe the recorded groups but do not, on their own, quantify uncertainty around a between-group effect.
The registry record also lists deaths: 13 in the Bempedoic Acid group and 2 in the placebo group. It does not report the timing, causes, or relationship to study treatment for these deaths in the available information. These counts should be read as descriptive safety information, not as proof of causation or as a standalone measure of comparative risk.
Several serious-event terms are listed with percentages, including Angina unstable at 1.6%, Angina pectoris at 0.8%, Coronary artery disease at 0.8%, Acute myocardial infarction at 0.7%, Myocardial infarction at 0.7%, and Non-cardiac chest pain at 0.5%. The registry record does not specify the denominator for these term percentages in the available information. They should not be treated as a complete account of all serious events or as direct treatment-effect estimates.
General statistical context: raw event counts are influenced by both the number of people observed and the event frequency. A comparison is more informative when it includes clearly defined populations, comparable observation periods, and an uncertainty estimate. Even with these elements, an association in a trial’s safety data does not establish that treatment caused an event. The registry record’s safety population definition and event window help frame the information, but the absent aggregate primary result limits how fully the main safety comparison can be interpreted.
9. Statistical Methods Explained
The registry record identifies a randomized, triple-masked, parallel-group phase 3 study. It reports a safety endpoint based on the percentage of participants with TEAEs and also lists serious adverse event counts. The statistical details available for interpreting those outcomes are limited: the primary outcome is not reduced to one comparison, and the registry record does not report the complete statistical analysis plan.
What does a percentage endpoint represent?
General statistical explanation: a binary event endpoint classifies each participant according to whether the defined event occurred during the stated period. A group percentage is the number of participants meeting that event definition divided by the number in the relevant analysis population, expressed as a percentage. It differs from an event count when one participant can experience more than one event: the percentage of participants with an event counts each person once for that endpoint, while a total event count may include repeated events.
For this trial, the primary endpoint was the percentage of participants with TEAEs. The registry definition includes events that began or worsened after the first dose and up to 30 days after the last dose, with collection for up to approximately 52 weeks. The registry record says the primary outcome has several categories or time points and was not reduced to one comparison. Thus, the available entry does not supply one overall percentage per group for a direct comparison.
Why does the analysis population matter?
The stated safety population contains randomized participants who received at least 1 dose of investigational medicinal product. Participants were included in the treatment group they received, regardless of randomized treatment. This is a treatment-received approach for the safety outcome. It can differ from an analysis based strictly on original random assignment, because participants may be classified according to exposure rather than their randomized group. The registry record does not report whether other analysis populations were used for other outcomes.
General statistical explanation: analysis populations need to be specified because including or excluding participants can alter both the numerator and denominator of a percentage. A clear population definition is especially important for safety outcomes, where exposure to study treatment is relevant. It does not resolve every issue: the record would also need to explain handling of participants with incomplete follow-up, missing event information, and treatment interruptions for a full account.
What can event counts tell readers?
The serious adverse event information gives counts and numbers at risk for each group. These figures are descriptive. They do not show how events were distributed over time, whether a person experienced more than one event, or whether event duration differed. The registry record does not report those details in the available information. The separate list of serious-event terms and percentages gives additional descriptive context, but the denominator for those percentages is not reported in the registry record.
General statistical explanation: a confidence interval describes uncertainty around an estimated quantity under a statistical model. It is not a guarantee that the true value lies within the interval, and its interpretation depends on the method and assumptions used. No confidence interval for the primary endpoint or serious-event comparison is reported in the registry record. No p-value for the primary endpoint is reported either, so statistical significance cannot be assessed from the primary outcome information.
How should sample-size calculations be understood?
General statistical explanation: a sample-size calculation is a planning exercise that uses assumptions about the event rate, effect to detect, significance level, allocation, and statistical method. It is not a result observed in the trial. The registry record describes planning illustrations based on the observed effect, a two-sided significance level of 0.05, equal allocation, and a normal approximation. It states that the effect to detect is a stated fraction of the observed effect. These illustrations are not the trial’s own design justification, and the registry record does not report the rationale for the enrollment target.
For a binary outcome, the assumed event rate matters because it affects the uncertainty of a percentage and the number of participants needed to detect a specified difference. If the true effect differs from the planning assumption, the achieved precision can also differ. General statistical context: observed-effect-based planning is retrospective and should not be described as observed power. The registry record does not report a trial-specific sample-size justification or an interim-analysis plan.
Why can event rates be harder to interpret than percentages suggest?
General statistical explanation: percentages summarize the share of participants with an event, but they may omit event frequency and timing. Recurrent events can require methods that account for multiple events per person. Time-to-event methods can account for the time until an event and differing follow-up, but they require information and assumptions not captured by a simple percentage. The registry record does not report that the primary TEAE outcome was analyzed using a time-to-event method.
The registry also lists LDL-C outcomes as percent change and absolute change from baseline to Week 12. General statistical context: a continuous outcome is usually interpreted through a measure of location and variability, and a between-group estimate can be paired with a confidence interval. The numerical findings and statistical methods for those secondary outcomes are not reported in the registry record information available for this analysis. No specific model, adjustment set, or variance method should therefore be inferred.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 30 outcome measures and 8 analyses, including a primary safety endpoint and secondary LDL-C outcomes at Week 12. It does not report a multiplicity strategy, such as a prespecified hierarchy or adjustment for testing multiple outcomes. Without that information, the handling of the chance of false-positive findings across multiple analyses is not reported in the registry record. This absence does not establish that no strategy was used; it means the strategy cannot be described from the record.
The primary endpoint entry is not reduced to one comparison because it has several categories or time points. An overall primary TEAE result, and its statistical comparison, are therefore not reported in the registry record. The record also does not report confidence intervals, p-values, or an effect estimate for that aggregate endpoint in the available information.
Missing-data handling is not reported in the registry record. The record does not specify how participants with incomplete follow-up, missing event information, or missing Week 12 LDL-C measurements were handled. It also does not report whether sensitivity analyses assessed the effect of missing data. General statistical context: if participants with incomplete observations differ systematically from those with complete observations, estimates based only on complete data may not represent the full study population. The direction and size of any such effect cannot be inferred without information about the missingness and analysis methods.
The safety population definition is reported: randomized participants who received at least 1 dose, classified by the treatment they received, regardless of randomized treatment. The registry record does not describe other analysis populations or explain whether analyses for the secondary outcomes used different populations. It does not report the detailed statistical analysis plan, interim analyses, or the study’s sample-size justification.
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 |
|---|---|---|---|
| Bempedoic Acid | 216 | 1487 | 14.5% |
| Placebo | 104 | 742 | 14.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Bempedoic Acid | 13 of 1487 |
| Placebo | 2 of 742 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Bempedoic Acid | 792 of 1487 |
| Placebo | 381 of 742 |
Most frequent serious adverse event terms
| Event term | Organ system | Bempedoic Acid | Placebo |
|---|---|---|---|
| Angina unstable | Cardiac disorders | 18 of 1487 | 12 of 742 |
| Angina pectoris | Cardiac disorders | 11 of 1487 | 6 of 742 |
| Acute myocardial infarction | Cardiac disorders | 11 of 1487 | 5 of 742 |
| Coronary artery disease | Cardiac disorders | 9 of 1487 | 6 of 742 |
| Myocardial infarction | Cardiac disorders | 8 of 1487 | 5 of 742 |
| Non-cardiac chest pain | General disorders | 7 of 1487 | 4 of 742 |
| Atrial fibrillation | Cardiac disorders | 7 of 1487 | 1 of 742 |
| Cardiac failure | Cardiac disorders | 5 of 1487 | 3 of 742 |
| Pneumonia | Infections and infestations | 6 of 1487 | 1 of 742 |
| Syncope | Nervous system disorders | 3 of 1487 | 3 of 742 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Bempedoic Acid | Placebo |
|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 146 of 1487 | 87 of 742 |
| Myalgia | Musculoskeletal and connective tissue disorders | 89 of 1487 | 45 of 742 |
| Urinary tract infection | Infections and infestations | 70 of 1487 | 47 of 742 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 64 of 1487 | 44 of 742 |
| Upper respiratory tract infection | Infections and infestations | 72 of 1487 | 31 of 742 |
| Dizziness | Nervous system disorders | 65 of 1487 | 31 of 742 |
| Diarrhoea | Gastrointestinal disorders | 60 of 1487 | 30 of 742 |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 62 of 1487 | 20 of 742 |
| Back pain | Musculoskeletal and connective tissue disorders | 55 of 1487 | 18 of 742 |
| Bronchitis | Infections and infestations | 52 of 1487 | 19 of 742 |
Serious events with the highest arm-level rate: angina unstable (1.6%), angina pectoris (0.8%), coronary artery disease (0.8%), acute myocardial infarction (0.7%), myocardial infarction (0.7%).
The registry record lists serious adverse event counts for two groups. In the Bempedoic Acid group, 216 participants with serious adverse events are reported among 1487 at risk. In the placebo group, 104 are reported among 742 at risk. These counts describe the recorded groups; they are not adjusted estimates and do not themselves establish a causal relationship to treatment.
The record separately lists 13 deaths in the Bempedoic Acid group and 2 in the placebo group. Timing, causes, and relationship to treatment are not reported in the registry record. The listed serious-event terms include Angina unstable (1.6%), Angina pectoris (0.8%), Coronary artery disease (0.8%), Acute myocardial infarction (0.7%), Myocardial infarction (0.7%), and Non-cardiac chest pain (0.5%). The denominator for those term percentages is not reported in the registry record.
General statistical context: a serious adverse event count is not the same as the number of all adverse events, since participants may have multiple events and seriousness is a specific classification. The listed counts should be interpreted alongside the defined population and observation period. The available record does not provide an uncertainty interval or a formal comparative analysis for these figures.
12. What the Result Does, and Does Not, Mean
The registry record establishes the trial’s purpose, design, primary endpoint definition, and selected safety counts. It describes a randomized, triple-masked, parallel-group phase 3 comparison of ETC-1002 180 mg/day with placebo in patients with high cardiovascular risk and elevated LDL cholesterol that was not adequately controlled by current therapy. The primary outcome was the percentage of participants with TEAEs during a collection period of up to approximately 52 weeks.
The posted primary outcome information does not give a single overall result for the primary endpoint. The registry record says the outcome has several categories or time points and was not reduced to one comparison. Therefore, the information available does not support a numerical statement about the overall TEAE percentage in either group or a single comparative estimate. The registry record also does not report a confidence interval or p-value for that primary comparison.
The serious adverse event counts and listed terms provide descriptive safety information, but they do not establish that a treatment caused an event. The death counts likewise do not identify timing, cause, or treatment relationship in the available record. The listed LDL-C outcomes identify secondary measures, but their numerical results are not reported in the registry record information available for this analysis.
General statistical context: a trial estimate is most informative when its outcome definition, analysis population, follow-up, effect estimate, and uncertainty are all clear. Randomization supports comparisons between assigned groups, but the safety population is defined by treatment received. The registry record does not provide enough detail to assess all aspects of missing data, multiplicity, or the statistical analysis plan.
These limits do not mean that no analyses were conducted. They mean that the registry record, as represented in the available information, does not report the details or results needed for a complete statistical interpretation of the primary endpoint. No conclusion about treatment benefit or lack of benefit follows from the absence of an aggregate primary safety comparison.
13. Why This Trial Matters Statistically
This trial is statistically notable because its primary outcome is a safety measure expressed as the percentage of participants with treatment-emergent adverse events, yet the registry record does not present the endpoint as one aggregate comparison. That distinction matters: an endpoint definition can be clear while the result remains difficult to interpret if the reported categories or time points are not consolidated into a single estimate.
The registry record identifies a safety population based on participants who received at least 1 dose, classified according to treatment received. This clarifies how the reported safety groups are defined, while also distinguishing them from a group assignment based solely on randomization. Readers need that distinction to understand which participants contribute to the safety counts.
The record’s serious adverse event figures are useful descriptive information, but counts alone do not convey precision or establish a treatment-related cause. No confidence intervals or formal comparative test results for the primary endpoint or serious-event figures are reported in the registry record. The listed deaths and serious-event terms similarly require context that is not reported, including timing and causal assessment.
General statistical context: complete reporting of outcome definitions, denominators, effect estimates, uncertainty, missing-data handling, and multiplicity methods helps readers distinguish descriptive observations from comparative evidence. The registry record identifies multiple outcome measures and analyses but does not report a multiplicity approach. It also does not report the sample-size rationale or detailed statistical plan. These omissions limit assessment of how the primary question was planned and how strongly the posted findings can be interpreted.
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 provide a single aggregate result for the primary TEAE endpoint. It notes that the primary outcome has several categories or time points and was not reduced to one comparison. As a result, an overall percentage by group, between-group effect estimate, confidence interval, and p-value for that primary endpoint are not reported in the registry record.
The serious adverse event counts are reported, but the available information does not describe the timing of events, repeated events within participants, event duration, or the assessment of treatment relationship. The registry record also does not report the causes or timing of the listed deaths. The denominator for the percentages attached to the listed serious-event terms is not reported in the registry record.
The registry record does not report how missing data were handled, whether sensitivity analyses were conducted, or which analysis populations were used for outcomes other than safety. It lists 30 outcome measures and 8 analyses but does not describe a multiplicity strategy. The detailed statistical analysis plan, interim analyses, and sample-size justification are not reported in the registry record.
The listed secondary LDL-C outcomes are identified as changes from baseline to Week 12, but their numerical results and statistical methods are not reported in the registry record information available for this analysis. The registry record also does not describe which groups of people were masked despite labeling masking as triple.
These reporting gaps constrain interpretation of the posted information. They do not show that analyses or procedures were absent; they indicate that those details are not reported in the registry record. General statistical context: without estimates of uncertainty and transparent methods, readers cannot assess the precision or robustness of a comparison as fully as they could with complete reporting.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluation of Long-Term Safety and Tolerability of ETC-1002 in High-Risk Patients With Hyperlipidemia and High CV Risk (CLEAR Harmony) — NCT02666664.
- Registry record last updated 2020-05-11; status last verified 2020-04.
- Results first posted 2020-04-20.
- 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.
Continue through the Clinical Biostats statistical pathway
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18. Record Summary
CLEAR Harmony (NCT02666664) was a completed randomized, triple-masked, parallel-group phase 3 study sponsored by Esperion Therapeutics, Inc. It enrolled 2230 participants and compared ETC-1002, identified as bempedoic acid, at 180 mg/day with placebo. The study began on 2016-01-21 and had a primary completion date of 2018-02-21.
The primary endpoint was the percentage of participants with treatment-emergent adverse events, collected for up to approximately 52 weeks. The registry record defines the safety population as randomized participants who received at least 1 dose, grouped by treatment received. It also lists Week 12 LDL-C outcomes and serious adverse event counts.
The primary outcome was not reduced to one comparison in the registry record. Numerical results for the aggregate primary endpoint, its uncertainty, multiplicity handling, missing-data methods, and detailed statistical plan are not reported in the registry record information available for this analysis.