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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002277-11 | EudraCT Number |
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A study to assess safety and efficacy of evolocumab (AMG-145) in paediatric subjects aged 10-17 years diagnosed with heterozygous familial hypercholesterolemia.
A study to evaluate the effect of 24 weeks of subcutaneous (SC) evolocumab compared with placebo, when added to standard of care, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in pediatric subjects 10 to 17 years of age with heterozygous familial hypercholesterolemia (HeFH).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Matching subcutaneous injection every 4 weeks (QM) |
|
| EvoMab 420 mg QM | Experimental | Evolocumab subcutaneous injection QM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evolocumab | Drug | Dose of subcutaneous evolocumab every 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline to Week 24 in LDL-C | Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from interactive voice response system [IVRS]), scheduled visit and the interaction of treatment with scheduled visit as covariates. The model uses an unstructured covariance. | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change From Baseline to Mean of Weeks 22 and 24 in LDL-C | Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from IVRS), scheduled visit and the interaction of treatment with scheduled visit as covariates. | Baseline, Week 22, Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Farmington | Connecticut | 06032 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32865373 | Background | Santos RD, Ruzza A, Hovingh GK, Wiegman A, Mach F, Kurtz CE, Hamer A, Bridges I, Bartuli A, Bergeron J, Szamosi T, Santra S, Stefanutti C, Descamps OS, Greber-Platzer S, Luirink I, Kastelein JJP, Gaudet D; HAUSER-RCT Investigators. Evolocumab in Pediatric Heterozygous Familial Hypercholesterolemia. N Engl J Med. 2020 Oct 1;383(14):1317-1327. doi: 10.1056/NEJMoa2019910. Epub 2020 Aug 29. | |
| 30318065 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
Participants were randomized in a 2:1 ratio to receive 24 weeks of monthly (QM) evolocumab or placebo. Randomization was stratified by screening low-density lipoprotein cholesterol (LDL-C; < 160 mg/dL vs ≥ 160 mg/dL) and age (< 14 years vs ≥ 14 years).
Participants were enrolled from 24 March 2016 to 30 May 2019 at 8 research centers in North America, 30 research centers in Europe, 6 research centers in Latin America, and 3 research centers in Asia Pacific.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matching subcutaneous injection QM |
| FG001 | EvoMab 420 mg QM | Evolocumab subcutaneous injection QM |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 1, 2015 | Jun 9, 2020 |
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| Placebo | Drug | Dose of subcutaneous placebo treatment every 4 weeks |
|
| Change From Baseline to Week 24 in LDL-C |
Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from IVRS), scheduled visit and the interaction of treatment with scheduled visit as covariates. |
| Baseline, Week 24 |
| Percent Change From Baseline to Week 24 in Non-HDL-C | Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from IVRS), scheduled visit and the interaction of treatment with scheduled visit as covariates | Baseline, Week 24 |
| Percent Change From Baseline to Week 24 in Apoliprotein-B (ApoB) | Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from IVRS), scheduled visit and the interaction of treatment with scheduled visit as covariates. | Baseline, Week 24 |
| Percent Change From Baseline to Week 24 in Total Cholesterol/HDL-C Ratio | Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from IVRS), scheduled visit and the interaction of treatment with scheduled visit as covariates. | Baseline, Week 24 |
| Percent Change From Baseline to Week 24 in ApoB:ApoA1 Ratio | Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from IVRS), scheduled visit and the interaction of treatment with scheduled visit as covariates. | Baseline, Week 24 |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation (DC), Fatal TEAEs, and Device-Related TEAEs | An adverse event (AE) is defined as any untoward medical occurrence that does not necessarily have a causal relationship with study treatment. An SAE is defined as an adverse event that: is fatal; is a life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other medically important serious event. Events were graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grading scale (1=mild; 2=moderate; 3=severe; 4=life-threatening; 5=death). Events were defined as treatment emergent if they occurred after the first dose of study drug and up to and including 30 days after the last dose or the end of study date, whichever is earlier. | From first dose of study drug up to and including 30 days after the last dose or end of study date (Week 24), whichever was earlier. Mean (SD) duration on study was 5.664 (0.278) and 5.608 (0.137) months for Placebo and EvoMab arms, respectively. |
| Number of Participants With Maximum Post-Baseline Laboratory Toxicities of Grade ≥ 3 | Laboratory toxicity grading was based on NCI CTCAE grading. Grade 3 indicates severe toxicity and Grade 4 indicates life-threatening toxicity. Values representing a worsening from baseline are shown. | Week 24 |
| Change From Baseline Over Time in Systolic Blood Pressure | Baseline, Week 4, Week 12, Week 20, Week 22, Week 24 |
| Change From Baseline Over Time in Diastolic Blood Pressure | Baseline, Week 4, Week 12, Week 20, Week 22, Week 24 |
| Change From Baseline Over Time in Heart Rate | Baseline, Week 4, Week 12, Week 20, Week 22, Week 24 |
| Number of Participants Testing Positive for Anti-Evolocumab Antibodies | up to Week 24 |
| Serum Evolocumab Concentrations Over Time | Week 12, Week 22, Week 24 |
| Wilmington |
| Delaware |
| 19803 |
| United States |
| Research Site | Iowa City | Iowa | 52242 | United States |
| Research Site | Towson | Maryland | 21204 | United States |
| Research Site | Minneapolis | Minnesota | 55454 | United States |
| Research Site | The Bronx | New York | 10467 | United States |
| Research Site | Asheville | North Carolina | 28803 | United States |
| Research Site | Cincinnati | Ohio | 45227 | United States |
| Research Site | Pittsburgh | Pennsylvania | 15224 | United States |
| Research Site | Nashville | Tennessee | 37212 | United States |
| Research Site | Salt Lake City | Utah | 84113 | United States |
| Research Site | Morgantown | West Virginia | 26506 | United States |
| Research Site | Camperdown | New South Wales | 2050 | Australia |
| Research Site | Feldkirch | 6800 | Austria |
| Research Site | Salzburg | 5020 | Austria |
| Research Site | Vienna | 1090 | Austria |
| Research Site | Brussels | 1200 | Belgium |
| Research Site | La Louvière | 7100 | Belgium |
| Research Site | Leuven | 3000 | Belgium |
| Research Site | Fortaleza | Ceará | 60430-270 | Brazil |
| Research Site | Vitória | Espírito Santo | 29055-450 | Brazil |
| Research Site | Brasília | Federal District | 71625-175 | Brazil |
| Research Site | São Paulo | 04040-000 | Brazil |
| Research Site | São Paulo | 05403-000 | Brazil |
| Research Site | Chicoutimi | Quebec | G7H 5H6 | Canada |
| Research Site | Chicoutimi | Quebec | G7H 7K9 | Canada |
| Research Site | Québec | Quebec | G1V 4W2 | Canada |
| Research Site | Barranquilla | Atlántico | 080020 | Colombia |
| Research Site | Floridablanca | Santander Department | Colombia |
| Research Site | Ostrava-Poruba | 708 52 | Czechia |
| Research Site | Prague | 150 06 | Czechia |
| Research Site | Svitavy | 568 25 | Czechia |
| Research Site | Helsinki | 00029 | Finland |
| Research Site | Kuopio | 70029 | Finland |
| Research Site | Athens | 17674 | Greece |
| Research Site | Thessaloniki | 54642 | Greece |
| Research Site | Budapest | 1094 | Hungary |
| Research Site | Palermo | 90127 | Italy |
| Research Site | Pisa | 56124 | Italy |
| Research Site | Roma | 00161 | Italy |
| Research Site | Roma | 00165 | Italy |
| Research Site | Torino | 10126 | Italy |
| Research Site | Kota Bharu | Kelantan | 16150 | Malaysia |
| Research Site | Amsterdam | 1105 AZ | Netherlands |
| Research Site | Christchurch | 8011 | New Zealand |
| Research Site | Bergen | 5021 | Norway |
| Research Site | Oslo | 0586 | Norway |
| Research Site | Gdansk | 80-952 | Poland |
| Research Site | Guimarães | 4835-044 | Portugal |
| Research Site | Moscow | 125412 | Russia |
| Research Site | Saint Petersburg | 191025 | Russia |
| Research Site | Ljubljana | 1000 | Slovenia |
| Research Site | Pretoria | Gauteng | 0087 | South Africa |
| Research Site | Parow | Western Cape | 7505 | South Africa |
| Research Site | Córdoba | Andalusia | 14004 | Spain |
| Research Site | Seville | Andalusia | 41013 | Spain |
| Research Site | Barcelona | Catalonia | 08036 | Spain |
| Research Site | A Coruña | Galicia | 15001 | Spain |
| Research Site | Lugo | Galicia | 27003 | Spain |
| Research Site | Geneva | 1211 | Switzerland |
| Research Site | Reinach | 4153 | Switzerland |
| Research Site | Taipei | 11217 | Taiwan |
| Research Site | Ankara | 06500 | Turkey (Türkiye) |
| Research Site | Izmir | 35100 | Turkey (Türkiye) |
| Research Site | Birmingham | B4 6NH | United Kingdom |
| Research Site | London | WC1N 3JH | United Kingdom |
| Background |
| Gaudet D, Langslet G, Gidding SS, Luirink IK, Ruzza A, Kurtz C, Lu C, Somaratne R, Raal FJ, Wiegman A. Efficacy, safety, and tolerability of evolocumab in pediatric patients with heterozygous familial hypercholesterolemia: Rationale and design of the HAUSER-RCT study. J Clin Lipidol. 2018 Sep-Oct;12(5):1199-1207. doi: 10.1016/j.jacl.2018.05.007. Epub 2018 May 22. |
| 36210291 | Background | Gaudet D, Ruzza A, Bridges I, Maruff P, Schembri A, Hamer A, Mach F, Bergeron J, Gaudet I, Pierre JS, Kastelein JJP, Hovingh GK, Wiegman A, Raal FJ, Santos RD. Cognitive function with evolocumab in pediatric heterozygous familial hypercholesterolemia. J Clin Lipidol. 2022 Sep-Oct;16(5):676-684. doi: 10.1016/j.jacl.2022.07.005. Epub 2022 Jul 21. |
| 33078867 | Derived | Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD011748. doi: 10.1002/14651858.CD011748.pub3. |
| Randomized and Dosed |
|
| COMPLETED |
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| NOT COMPLETED |
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Full Analysis Set: participants who were randomized and dosed.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matching subcutaneous injection QM |
| BG001 | EvoMab 420 mg QM | Evolocumab subcutaneous injection QM |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Stratification Factor: Age Group | Number | participants |
| ||||||||||||||||
| Stratification Factor: Screening LDL-C Level | Number | participants |
| ||||||||||||||||
| LDL-C | Mean | Standard Deviation | mg/dL |
| |||||||||||||||
| Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) | Mean | Standard Deviation | mg/dL |
| |||||||||||||||
| Total Cholesterol/HDL-C Ratio | Mean | Standard Deviation | ratio |
| |||||||||||||||
| Apolipoprotein B (ApoB) | participants with a baseline measurement | Mean | Standard Deviation | mg/dL |
| ||||||||||||||
| ApoB/Apolipoprotein A1 (ApoA1) Ratio | participants with a baseline measurement | Mean | Standard Deviation | ratio |
| ||||||||||||||
| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
| |||||||||||||||
| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
| |||||||||||||||
| Heart Rate | Mean | Standard Deviation | beats per minute |
|
| 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 24 in LDL-C | Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from interactive voice response system [IVRS]), scheduled visit and the interaction of treatment with scheduled visit as covariates. The model uses an unstructured covariance. | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. | Posted | Least Squares Mean | Standard Error | percent change | Baseline, Week 24 |
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| Secondary | Mean Percent Change From Baseline to Mean of Weeks 22 and 24 in LDL-C | Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from IVRS), scheduled visit and the interaction of treatment with scheduled visit as covariates. | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. | Posted | Least Squares Mean | Standard Error | percent change | Baseline, Week 22, Week 24 |
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| Secondary | Change From Baseline to Week 24 in LDL-C | Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from IVRS), scheduled visit and the interaction of treatment with scheduled visit as covariates. | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline, Week 24 |
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| Secondary | Percent Change From Baseline to Week 24 in Non-HDL-C | Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from IVRS), scheduled visit and the interaction of treatment with scheduled visit as covariates | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. | Posted | Least Squares Mean | Standard Error | percent change | Baseline, Week 24 |
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| Secondary | Percent Change From Baseline to Week 24 in Apoliprotein-B (ApoB) | Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from IVRS), scheduled visit and the interaction of treatment with scheduled visit as covariates. | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. | Posted | Least Squares Mean | Standard Error | percent change | Baseline, Week 24 |
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| Secondary | Percent Change From Baseline to Week 24 in Total Cholesterol/HDL-C Ratio | Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from IVRS), scheduled visit and the interaction of treatment with scheduled visit as covariates. | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. | Posted | Least Squares Mean | Standard Error | percent change | Baseline, Week 24 |
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| Secondary | Percent Change From Baseline to Week 24 in ApoB:ApoA1 Ratio | Least squares mean is from the repeated measures model which includes treatment group, stratification factors of age and screening LDL-C (from IVRS), scheduled visit and the interaction of treatment with scheduled visit as covariates. | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. | Posted | Least Squares Mean | Standard Error | percent change | Baseline, Week 24 |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation (DC), Fatal TEAEs, and Device-Related TEAEs | An adverse event (AE) is defined as any untoward medical occurrence that does not necessarily have a causal relationship with study treatment. An SAE is defined as an adverse event that: is fatal; is a life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other medically important serious event. Events were graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grading scale (1=mild; 2=moderate; 3=severe; 4=life-threatening; 5=death). Events were defined as treatment emergent if they occurred after the first dose of study drug and up to and including 30 days after the last dose or the end of study date, whichever is earlier. | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. | Posted | Number | participants | From first dose of study drug up to and including 30 days after the last dose or end of study date (Week 24), whichever was earlier. Mean (SD) duration on study was 5.664 (0.278) and 5.608 (0.137) months for Placebo and EvoMab arms, respectively. |
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| Secondary | Number of Participants With Maximum Post-Baseline Laboratory Toxicities of Grade ≥ 3 | Laboratory toxicity grading was based on NCI CTCAE grading. Grade 3 indicates severe toxicity and Grade 4 indicates life-threatening toxicity. Values representing a worsening from baseline are shown. | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. | Posted | Number | participants | Week 24 |
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| Secondary | Change From Baseline Over Time in Systolic Blood Pressure | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. | Posted | Mean | Standard Deviation | mmHg | Baseline, Week 4, Week 12, Week 20, Week 22, Week 24 |
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| Secondary | Change From Baseline Over Time in Diastolic Blood Pressure | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. | Posted | Mean | Standard Deviation | mmHg | Baseline, Week 4, Week 12, Week 20, Week 22, Week 24 |
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| Secondary | Change From Baseline Over Time in Heart Rate | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. | Posted | Mean | Standard Deviation | beats per minute | Baseline, Week 4, Week 12, Week 20, Week 22, Week 24 |
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| Secondary | Number of Participants Testing Positive for Anti-Evolocumab Antibodies | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants receiving evolocumab. | Posted | Count of Participants | Participants | up to Week 24 |
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| Secondary | Serum Evolocumab Concentrations Over Time | Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. | Posted | Mean | Standard Deviation | ng/mL | Week 12, Week 22, Week 24 |
|
|
|
Fatal AEs: from first dose date to end of study date (Week 24); non-fatal AEs: from first dose of study drug up to 30 days after last dose or end of study date, whichever was earlier. Mean (SD) duration on study was 5.664 (0.278) and 5.608 (0.137) months for the Placebo and EvoMab arms, respectively.
All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo SC QM | Matching subcutaneous injection QM | 0 | 53 | 0 | 53 | 19 | 53 |
| EG001 | EvoMab 420 mg SC QM | Evolocumab subcutaneous injection QM | 0 | 105 | 1 | 104 | 41 | 104 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 16, 2019 | Jun 9, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C577155 | evolocumab |
Not provided
Not provided
Not provided
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| Black (or African American) |
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| White |
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| Other, Not Specified |
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| ≥ 14 years |
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| ≥ 160 mg/dL |
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Adjusted p-value is compared to 0.05 to determine statistical significance. |
| < 0.0001 |
Adjusted p-value based on a combination of sequential testing and the Hochberg procedure to control the overall significance level for all primary and secondary endpoints. |
| Superiority |
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Evolocumab subcutaneous injection QM
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| Categories |
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| Week 12 |
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| Week 22 |
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| Week 24 |
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