Trial · NCT02666664
Evaluation of Long-Term Safety and Tolerability of ETC-1002 in High-Risk Patients With Hyperlipidemia and High CV Risk (CLEAR Harmony)
NCT02666664, Phase 3, Completed, Esperion Therapeutics, Inc.; results first posted 2020-04-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of Long-Term Safety and Tolerability of ETC-1002 in High-Risk Patients With Hyperlipidemia and High CV Risk (CLEAR Harmony). Trials, record NCT02666664. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02666664
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Long-Term Safety and Tolerability of ETC-1002 in High-Risk Patients With Hyperlipidemia and High CV Risk (CLEAR Harmony)
- NCT number
- NCT02666664
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,230 participants, actual
- Lead sponsor
- Esperion Therapeutics, Inc.
- Conditions
- Hypercholesterolemia, Atherosclerotic Cardiovascular Diseases
- Interventions
- ETC-1002, Placebo
- First posted
- 2016-01-28
- Last updated
- 2020-05-11
- Other registries' IDs
- eudract:2015-004136-36
- Results first posted
- 2020-04-20
Source ClinicalTrials.gov
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to approximately 52 weeks | TEAEs, defined as adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and up to 30 days after receiving the last dose of double-blind study drug, were collected and reported. |
| Primary | Percentage of Participants With Adjudicated Major Adverse Cardiovascular Event | Up to approximately 52 weeks | TEAEs, defined as AEs that began or worsened in severity after the first dose of double-blind study drug and up to 30 days after receiving the last dose of double-blind study drug, were collected and reported. Cardiovascular events were considered as adverse events of special interest. Treatment-emergent = TE. |
| Primary | Percentage of Participants With the Indicated Event of Special Interest: Creatine Kinase Elevations | Up to approximately 52 weeks | TEAEs of special interest (AESIs) were predefined and monitored throughout the study. Creatine kinase elevations were assessed using the following preferred term: Blood creatine phosphokinase increased (system organ class: investigations). |
| Primary | Percentage of Participants With the Indicated Event of Special Interest: Hepatic Disorders | Up to approximately 52 weeks | Treatment-emergent AESIs were predefined and monitored throughout the study. TEAEs potentially related to hepatic events were assessed using the following preferred terms and laboratory abnormalities: aspartate aminotransferase (AST) increased, Alanine aminotransferase (ALT) increased, Hepatic enzyme increased, Blood bilirubin increased, liver function test (LFT) abnormal, LFT increased, hepatic enzyme abnormal, transaminases increased, potential Hy's Law cases (PHLC) \[AST and (\&)/or ALT \>3 x upper limit of normal (ULN) with concurrent total bilirubin \>2 x ULN\], AST and/or ALT \>3 x ULN, and total bilirubin \>2 x ULN (system organ class: investigations). AST and ALT values were repeated and confirmed. "Repeated and confirmed" was defined as a participant having the last on-study LFT \> x ULN, the last on-treatment LFT \> x ULN, or LFT \> x ULN followed by another LFT \> x ULN. |
| Primary | Percentage of Participants With the Indicated Event of Special Interest: Hypoglycemia | Up to approximately 52 weeks | Treatment-emergent AESIs were predefined and monitored throughout the study. Hypoglycemia was assessed using the following preferred terms: hypoglycaemia (system organ class: metabolism and nutrition disorders); blood glucose abnormal and blood glucose decreased (system organ class: investigations). The percentage of unique participants is reported in the "Overall hypoglycemia AESIs" category; a participant could have been represented in more than one of the individual hypoglycemia AESIs. |
| Primary | Percentage of Participants With the Indicated Event of Special Interest: Metabolic Acidosis | Up to approximately 52 weeks | Treatment-emergent AESIs were predefined and monitored throughout the study. Metabolic acidosis was assessed using the preferred term metabolic acidosis (system organ class: metabolism and nutrition disorders). |
| Primary | Percentage of Participants With the Indicated Event of Special Interest: Muscular Disorder | Up to approximately 52 weeks | Treatment-emergent AESIs were predefined and monitored throughout the study. Muscular safety was assessed using the following preferred terms and laboratory abnormalities: myalgia, muscle spasms, pain in extremity, muscular weakness (system organ class: musculoskeletal and connective tissue disorders), and creatine kinase \>5 ULN (repeated and confirmed). The percentage of unique participants is reported in the "Overall muscular disorder AESIs" category; a participant could have been represented in more than one of the individual muscular disorder AESIs. |
| Primary | Percentage of Participants With the Indicated Event of Special Interest: Neurocognitive Disorder | Up to approximately 52 weeks | Treatment-emergent AESIs were predefined and monitored throughout the study. Neurocognitive disorder was assessed using the following preferred terms: memory impairment, amnesia, and cognitive disorder (system organ class: nervous system disorders); confusional state and disorientation (system organ class: psychiatric disorders). The percentage of unique participants is reported in the "Overall neurocognitive disorder AESIs" category; a participant could have been represented in more than one of the individual neurocognitive disorder AESIs. |
| Primary | Percentage of Participants With the Indicated Event of Special Interest: New Onset or Worsening Diabetes Mellitus | Up to approximately 52 weeks | Treatment-emergent AESIs were predefined and monitored throughout the study. New onset or worsening diabetes was assessed using the following preferred terms: type 2 diabetes mellitus, diabetes mellitus, hyperglycaemia, glucose tolerance impaired, diabetes mellitus inadequate control, and impaired fasting glucose (system organ class: metabolism and nutrition disorders); blood glucose increased, glycosylated haemoglobin increased, blood glucose abnormal, and glucose urine present (system organ class: investigations); and glycosuria (system organ class: renal and urinary disorders). The percentage of unique participants is reported in the "Overall new onset/worsening diabetes mellitus AESIs" category; a participant could have been represented in more than one of the individual new onset/worsening diabetes mellitus AESIs. |
| Primary | Percentage of Participants With the Indicated Event of Special Interest: Renal Disorder | Up to approximately 52 weeks | Treatment-emergent AESIs were predefined and monitored throughout the study. TEAEs potentially related to renal events were assessed using the following preferred terms: renal failure, renal impairment, acute kidney injury (system organ class: renal and urinary disorders); blood creatinine increased, glomerular filtration rate decreased, blood urea increased, estimated glomerular filtration rate (eGFR) \<30 milliliter per minute per 1.73 square meter (ml/min/1.73m\^2), and change from baseline in creatinine \>1 mg/dL (system organ class: investigations); and gout (system organ class: metabolism and nutrition disorders). The percentage of unique participants is reported in the "Overall renal disorder AESIs" category; a participant could have been represented in more than one of the individual renal disorder AESIs. |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 registered outcomesOutcomes30
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to approximately 52 weeks | 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. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Adjudicated Major Adverse Cardiovascular Event | Up to approximately 52 weeks | Safety Population | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With the Indicated Event of Special Interest: Creatine Kinase Elevations | Up to approximately 52 weeks | Safety Population | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With the Indicated Event of Special Interest: Hepatic Disorders | Up to approximately 52 weeks | Safety Population. The percentage of unique participants is reported in the Overall hepatic disorder AESIs category; a participant could have been represented in more than one of the individual hepatic disorder AESIs. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With the Indicated Event of Special Interest: Hypoglycemia | Up to approximately 52 weeks | Safety Population | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With the Indicated Event of Special Interest: Metabolic Acidosis | Up to approximately 52 weeks | Safety Population | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With the Indicated Event of Special Interest: Muscular Disorder | Up to approximately 52 weeks | Safety Population | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With the Indicated Event of Special Interest: Neurocognitive Disorder | Up to approximately 52 weeks | Safety Population | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With the Indicated Event of Special Interest: New Onset or Worsening Diabetes Mellitus | Up to approximately 52 weeks | Safety Population | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With the Indicated Event of Special Interest: Renal Disorder | Up to approximately 52 weeks | Safety Population | percentage of participants | NUMBER |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 outcomesResults by group178
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | Placebo | Any TEAE | 78.7 | percentage of participants | |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | Bempedoic Acid | Any TEAE | 78.5 | percentage of participants | |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | Placebo | Any serious TEAE | 14.0 | percentage of participants | |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | Bempedoic Acid | Any serious TEAE | 14.5 | percentage of participants | |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | Placebo | Any fatal TEAE | 0.3 | percentage of participants | |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | Bempedoic Acid | Any fatal TEAE | 0.9 | percentage of participants | |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | Placebo | Any TEAE leading to discontinuation of study drug | 7.1 | percentage of participants | |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | Bempedoic Acid | Any TEAE leading to discontinuation of study drug | 10.9 | percentage of participants | |
| Percentage of Participants With Adjudicated Major Adverse Cardiovascular Event | Placebo | Any adjudicated major clinical event | 5.7 | percentage of participants | |
| Percentage of Participants With Adjudicated Major Adverse Cardiovascular Event | Bempedoic Acid | Any adjudicated major clinical event | 4.6 | percentage of participants |
1 to 10 of 178Source ClinicalTrials.gov
See all 178 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 | 742 | |
| Overall Study | STARTED | Bempedoic Acid | 1,488 | |
| Overall Study | COMPLETED | Placebo | 706 | |
| Overall Study | COMPLETED | Bempedoic Acid | 1,404 | |
| Overall Study | NOT COMPLETED | Placebo | 36 | |
| Overall Study | NOT COMPLETED | Bempedoic Acid | 84 |
Source ClinicalTrials.gov
Adverse events512
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 | Anaemia | Blood and lymphatic system disorders | Bempedoic Acid | 41 | 1,487 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 15 | 742 | |
| other | Angina pectoris | Cardiac disorders | Bempedoic Acid | 24 | 1,487 | |
| other | Angina pectoris | Cardiac disorders | Placebo | 19 | 742 | |
| other | Nausea | Gastrointestinal disorders | Bempedoic Acid | 43 | 1,487 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 19 | 742 | |
| other | Constipation | Gastrointestinal disorders | Bempedoic Acid | 26 | 1,487 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 18 | 742 | |
| other | Diarrhoea | Gastrointestinal disorders | Bempedoic Acid | 60 | 1,487 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 30 | 742 |
1 to 10 of 512Source ClinicalTrials.gov
See all 512 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bempedoic Acid | 13 | 1,487 |
| Total, all-cause mortality | Placebo | 2 | 742 |
| Total, other adverse events | Bempedoic Acid | 792 | 1,487 |
| Total, other adverse events | Placebo | 381 | 742 |
| Total, serious adverse events | Bempedoic Acid | 216 | 1,487 |
| Total, serious adverse events | Placebo | 104 | 742 |
Source ClinicalTrials.gov
Papers9
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.
GET https://conductscience.org/api/trials/v1/NCT02666664
GET https://conductscience.org/api/trials/v1/NCT02666664/registered?page=2