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This study will assess the Low-Density Lipoprotein-Cholesterol (LDL-C) lowering efficacy and safety of ETC-1002 versus placebo in participants with hypercholesterolemia and a history of statin intolerance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ETC-1002 | Experimental | ETC-1002 treatment, once daily oral |
|
| Placebo | Placebo Comparator | Placebo treatment, once daily oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ETC-1002 | Drug | Weeks 1-2, 60 milligrams per day (mg/day); Weeks 3-4, 120 mg/day; Weeks 5-6, 180 mg/day; Weeks 7-8, 240 mg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline to Week 8 in Calculated Low-Density Lipoprotein-Cholesterol (LDL-C) | Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. Least square (LS) mean percent change from Baseline to Week 8 was based on an analysis of covariance (ANCOVA) model with effects of treatment and Baseline value as a covariate. Missing LDL-C values at Week 8 were imputed using the last observation carried forward (LOCF) procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement. | Baseline; 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline to Weeks 2, 4, 6, and 8 in Calculated LDL-C | Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. A negative percent change from Baseline reflects clinical improvement. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Esperion Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford | Connecticut | 06102 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26073387 | Result | Thompson PD, Rubino J, Janik MJ, MacDougall DE, McBride SJ, Margulies JR, Newton RS. Use of ETC-1002 to treat hypercholesterolemia in patients with statin intolerance. J Clin Lipidol. 2015 May-Jun;9(3):295-304. doi: 10.1016/j.jacl.2015.03.003. Epub 2015 Mar 19. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ETC-1002 | Participants initially received ETC-1002 60 milligrams (mg) once daily (QD) on Day 1 for 2 weeks, and then were titrated successively to 120 mg QD for 2 weeks, 180 mg QD for 2 weeks, and 240 mg QD for 2 weeks. |
| FG001 | Placebo | Participants received placebo QD on Day 1 for 8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline data are reported for members of the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | ETC-1002 | Participants initially received ETC-1002 60 milligrams (mg) once daily (QD) on Day 1 for 2 weeks, and then were titrated successively to 120 mg QD for 2 weeks, 180 mg QD for 2 weeks, and 240 mg QD for 2 weeks. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline was defined as the value from Week 0. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change From Baseline to Week 8 in Calculated Low-Density Lipoprotein-Cholesterol (LDL-C) | Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. Least square (LS) mean percent change from Baseline to Week 8 was based on an analysis of covariance (ANCOVA) model with effects of treatment and Baseline value as a covariate. Missing LDL-C values at Week 8 were imputed using the last observation carried forward (LOCF) procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement. | Modified Intent-to-Treat (mITT) Population: All randomized participants who received at least 1 dose of study medication and had a Baseline assessment and at least 1 post-Baseline assessment, excluding any assessments taken more than 2 days after a dose of study medication. The participant composition of this population could change depending on the parameter being analyzed. Only participants with available data were analyzed. | Posted | Least Squares Mean | Standard Error | Percent Change | Baseline; 8 weeks |
up to 8 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication, are reported. The analysis was performed using the Safety Population, comprised of all randomized participants who received at least 1 dose of study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ETC-1002 | Participants initially received ETC-1002 60 milligrams (mg) once daily (QD) on Day 1 for 2 weeks, and then were titrated successively to 120 mg QD for 2 weeks, 180 mg QD for 2 weeks, and 240 mg QD for 2 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thyroid Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Swelling | Eye disorders | MedDRA 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Esperion Therapeutics, Inc. | 1-833-377-7633 | medinfo@esperion.com |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C581236 | 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid |
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| Placebo | Drug | Placebo once daily for 8 weeks |
|
| Baseline; Weeks 2, 4, 6, and 8 |
| Percent Change From Baseline to Week 8 in High-Density Lipoprotein-Cholesterol (HDL-C) | Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement. | Baseline; 8 weeks |
| Percent Change From Baseline to Week 8 in Non-HDL-C | Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement. | Baseline; 8 weeks |
| Percent Change From Baseline to Week 8 in Total Cholesterol | Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement. | Baseline; 8 weeks |
| Percent Change From Baseline to Week 8 in Triglycerides | Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement. | Baseline; 8 weeks |
| Percent Change From Baseline to Week 8 in Apolipoprotein B | Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement. | Baseline; 8 weeks |
| Percent Change From Baseline to Week 8 in Apolipoprotein AI | Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement. | Baseline; 8 weeks |
| Percent Change From Baseline to Week 8 in Lipoprotein (a) | Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Data are based on the participant's last post-Baseline value. Only those participants having a valid assessment at Baseline and each subsequent time point were included in the summaries at that time point. Lipoprotein (a) results indicated as <3 in the laboratory data were set to 3 for purposes of analysis. A negative percent change from Baseline reflects clinical improvement. | Baseline; 8 weeks |
| Percent Change From Baseline to Week 8 in High-Sensitivity C-Reactive Protein (hsCRP) | Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Data were based on the participant's last post-Baseline value. Only those participants having a valid assessment at Baseline and each subsequent time point were included in the summaries at that time point. hsCRP results indicated as <0.2 in the laboratory data were set to 0.2 for purposes of analysis. A negative percent change from Baseline reflects clinical improvement. | Baseline; 8 weeks |
| Percent Change From Baseline to Week 8 in Free Fatty Acids (FFA) | Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Data were based on the participant's last post-Baseline value. | Baseline; 8 weeks |
| Number of Participants Achieving Their National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) LDL-C Goal (<100 Milligrams Per Deciliter [mg/dL]) After 8 Weeks of Treatment | Participants were analyzed to evaluate the LDL-C target of <100 mg/dL for high risk participants with cardiovascular diseases. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). | Baseline; up to 8 weeks |
| Number or Participants With Treatment-emergent Adverse Events (TEAEs) | TEAEs were defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication. | up to 8 weeks |
| Number of Participants With Muscle-Related TEAEs | TEAEs were defined as AEs that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication. | up to 8 weeks |
| Indianapolis |
| Indiana |
| 46260 |
| United States |
| Raleigh | North Carolina | 27609 | United States |
| Wilmington | North Carolina | 28401 | United States |
| Knoxville | Tennessee | 37912 | United States |
| Per Investigator/Sponsor/Regulatory Body |
|
Participants received placebo QD on Day 1 for 8 weeks. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Baseline was defined as the value from Week 0. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Baseline was defined as the value from Week 0. | Count of Participants | Participants |
|
| Calculated Low-density Lipoprotein Cholesterol (LDL-C) | Baseline was defined as the value from Week 0. | Only participants with available data were analyzed. | Mean | Standard Deviation | milligrams per deciliter (mg/dL) |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | ETC-1002 | Participants initially received ETC-1002 60 milligrams (mg) once daily (QD) on Day 1 for 2 weeks, and then were titrated successively to 120 mg QD for 2 weeks, 180 mg QD for 2 weeks, and 240 mg QD for 2 weeks. |
| OG001 | Placebo | Participants received placebo QD on Day 1 for 8 weeks. |
|
|
|
| Secondary | Percent Change From Baseline to Weeks 2, 4, 6, and 8 in Calculated LDL-C | Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. A negative percent change from Baseline reflects clinical improvement. | Completers Population: All randomized participants who received at least 1 dose of study medication and had a Baseline assessment and an assessment at the specified time point, excluding any assessments taken more than 2 days after a dose of study medication. The participant composition of this population could change depending on the parameter being analyzed. Only participants with available data were analyzed. | Posted | Least Squares Mean | Standard Error | Percent Change | Baseline; Weeks 2, 4, 6, and 8 |
|
|
|
|
| Secondary | Percent Change From Baseline to Week 8 in High-Density Lipoprotein-Cholesterol (HDL-C) | Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement. | mITT Population. The participant composition of this population could change depending on the parameter being analyzed. | Posted | Least Squares Mean | Standard Deviation | Percent Change | Baseline; 8 weeks |
|
|
|
|
| Secondary | Percent Change From Baseline to Week 8 in Non-HDL-C | Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement. | mITT Population. The participant composition of this population could change depending on the parameter being analyzed. | Posted | Least Squares Mean | Standard Error | Percent Change | Baseline; 8 weeks |
|
|
|
|
| Secondary | Percent Change From Baseline to Week 8 in Total Cholesterol | Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement. | mITT Population. The participant composition of this population could change depending on the parameter being analyzed. | Posted | Least Squares Mean | Standard Error | Percent Change | Baseline; 8 weeks |
|
|
|
|
| Secondary | Percent Change From Baseline to Week 8 in Triglycerides | Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement. | mITT Population. The participant composition of this population could change depending on the parameter being analyzed. | Posted | Least Squares Mean | Standard Error | Percent Change | Baseline; 8 weeks |
|
|
|
|
| Secondary | Percent Change From Baseline to Week 8 in Apolipoprotein B | Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement. | mITT Population. The participant composition of this population could change depending on the parameter being analyzed. Only participants with available data were analyzed. | Posted | Least Squares Mean | Standard Error | Percent Change | Baseline; 8 weeks |
|
|
|
|
| Secondary | Percent Change From Baseline to Week 8 in Apolipoprotein AI | Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement. | mITT Population. The participant composition of this population could change depending on the parameter being analyzed. Only participants with available data were analyzed. | Posted | Least Squares Mean | Standard Error | Percent Change | Baseline; 8 weeks |
|
|
|
|
| Secondary | Percent Change From Baseline to Week 8 in Lipoprotein (a) | Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Data are based on the participant's last post-Baseline value. Only those participants having a valid assessment at Baseline and each subsequent time point were included in the summaries at that time point. Lipoprotein (a) results indicated as <3 in the laboratory data were set to 3 for purposes of analysis. A negative percent change from Baseline reflects clinical improvement. | mITT Population. The participant composition of this population could change depending on the parameter being analyzed. Only participants with available data were analyzed. | Posted | Least Squares Mean | Standard Error | Percent Change | Baseline; 8 weeks |
|
|
|
|
| Secondary | Percent Change From Baseline to Week 8 in High-Sensitivity C-Reactive Protein (hsCRP) | Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Data were based on the participant's last post-Baseline value. Only those participants having a valid assessment at Baseline and each subsequent time point were included in the summaries at that time point. hsCRP results indicated as <0.2 in the laboratory data were set to 0.2 for purposes of analysis. A negative percent change from Baseline reflects clinical improvement. | mITT Population. The participant composition of this population could change depending on the parameter being analyzed. Only participants with available data were analyzed. | Posted | Least Squares Mean | Standard Error | Percent Change | Baseline; 8 weeks |
|
|
|
|
| Secondary | Percent Change From Baseline to Week 8 in Free Fatty Acids (FFA) | Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. LS mean percent change from Baseline to Week 8 was based on an ANCOVA model with effects of treatment and Baseline value as a covariate. Data were based on the participant's last post-Baseline value. | mITT Population. The participant composition of this population could change depending on the parameter being analyzed. Only participants with available data were analyzed. | Posted | Least Squares Mean | Standard Error | Percent Change | Baseline; 8 weeks |
|
|
|
|
| Secondary | Number of Participants Achieving Their National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) LDL-C Goal (<100 Milligrams Per Deciliter [mg/dL]) After 8 Weeks of Treatment | Participants were analyzed to evaluate the LDL-C target of <100 mg/dL for high risk participants with cardiovascular diseases. Missing values at Week 8 were imputed using the LOCF procedure (only post-Baseline values were carried forward). | mITT Population. The participant composition of this population could change depending on the parameter being analyzed. Only participants with available data were analyzed. | Posted | Count of Participants | Participants | Baseline; up to 8 weeks |
|
|
|
|
| Secondary | Number or Participants With Treatment-emergent Adverse Events (TEAEs) | TEAEs were defined as adverse events (AEs) that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication. | Safety Population: all randomized participants who received at least 1 dose of study medication | Posted | Count of Participants | Participants | up to 8 weeks |
|
|
|
| Secondary | Number of Participants With Muscle-Related TEAEs | TEAEs were defined as AEs that began or worsened in severity after the first dose of study medication, occurring up to 30 days after the last dose of study medication. | Safety Population | Posted | Count of Participants | Participants | up to 8 weeks |
|
|
|
| 0 |
| 37 |
| 1 |
| 37 |
| 19 |
| 37 |
| EG001 | Placebo | Participants received placebo QD on Day 1 for 8 weeks. | 0 | 19 | 0 | 19 | 15 | 19 |
| Change Of Bowel Habit | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Rhinovirus Infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Muscle Strain | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Blood Creatine Phosphokinase Increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| White Blood Cells Urine Positive | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Joint Stiffness | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Muscle Fatigue | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Muscle Tightness | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Musculoskeletal Stiffness | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Plantar Fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dizziness Postural | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
Not provided
Not provided
| D009750 |
| Nutritional and Metabolic Diseases |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Week 4 |
|
|
| Week 6 |
|
|
| Week 8 |
|
|
| <0.0001 |
| Least squares mean difference |
| -30.0 |
| 2-Sided |
| 95 |
| -35.2 |
| -24.7 |
Estimation from Week 4. The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm. |
| Superiority |
| ANCOVA | <0.0001 | Least squares mean difference | -28.8 | 2-Sided | 95 | -36.9 | -20.8 | Estimation from Week 6. The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm. | Superiority |
| ANCOVA | <0.0001 | Least squares mean difference | -28.5 | 2-Sided | 95 | -37.2 | -19.8 | Estimation from Week 8. The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm. | Superiority |