Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004735-12 | EudraCT Number |
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The study is divided into 2 parts. The first part of the study will be double-blinded and will last for 24 weeks. During this time, participants will be randomized in a ratio of 2:1 to receive either evolocumab once monthly (QM) or placebo QM. The second part of the study is a 24-week open label extension period. During this time all participants will receive evolocumab QM.
The clinical hypothesis is that subcutaneous evolocumab QM will be well tolerated and will result in greater reduction of low density lipoprotein cholesterol (LDL-C), defined as percent change from baseline at Week 24, compared with placebo QM in human immunodeficiency virus (HIV)-positive participants with hyperlipidemia or mixed dyslipidemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double-Blind Placebo SC QM/Open-Label Evolocumab 420 mg SC QM | Experimental | Double-blind placebo subcutaneous (SC) injection every 4 weeks (QM) for 24 weeks, followed by open-label evolocumab 420 mg SC QM for 24 weeks. |
|
| Double-Blind Evolocumab 420 mg SC QM/Open-Label Evolocumab 420 mg SC QM | Placebo Comparator | Double-blind evolocumab SC injection QM for 24 weeks, followed by open-label evolocumab 420 mg SC QM for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evolocumab | Drug | Dose of subcutaneous evolocumab QM |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in LDL-C at Week 24 | Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.) | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in LDL-C at Week 24 | Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.) | Baseline, Week 24 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Los Angeles | California | 90035 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32234462 | Background | Boccara F, Kumar PN, Caramelli B, Calmy A, Lopez JAG, Bray S, Cyrille M, Rosenson RS; BEIJERINCK Investigators. Evolocumab in HIV-Infected Patients With Dyslipidemia: Primary Results of the Randomized, Double-Blind BEIJERINCK Study. J Am Coll Cardiol. 2020 May 26;75(20):2570-2584. doi: 10.1016/j.jacc.2020.03.025. Epub 2020 Mar 28. | |
| 31841795 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
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 evolocumab or placebo, respectively, in a double-blind manner. Randomization was stratified by entry statin treatment and hepatitis C status.
This study was conducted at 72 centers in Australia, Belgium, Brazil, Canada, France, Greece, Italy, Poland, Portugal, Romania, South Africa, Spain, Switzerland, United Kingdom, and United States. The first participant was enrolled on 22 May 2017, and the last participant was enrolled on 23 January 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Double-Blind Placebo/Open-Label Evolocumab | Double-blind placebo subcutaneous (SC) injection every 4 weeks (QM) for 24 weeks in the double-blind period, followed by open-label evolocumab 420 mg SC QM for 24 weeks in the open-label period. |
| FG001 | Double-Blind Evolocumab/Open-Label Evolocumab |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Double-Blind Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 30, 2017 | Jun 25, 2020 |
Not provided
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Not provided
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Not provided
|
| Placebo | Drug | Dose of matching placebo QM |
|
| Percentage of Participants Acheiving LDL-C < 70 mg/dL (1.8 mmol/L) at Week 24 | Week 24 |
| Percentage of Participants With an LDL-C Response (50% Reduction of LDL-C From Baseline) at Week 24 | Baseline, Week 24 |
| Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (HDL-C) at Week 24 | Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.) | Baseline, Week 24 |
| Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24 | Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.) | Baseline, Week 24 |
| Percent Change From Baseline in Total Cholesterol (TC) at Week 24 | Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.) | Baseline, Week 24 |
| Percent Change From Baseline in Lipoprotein(a) (Lp[a]) at Week 24 | Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.) | Baseline, Week 24 |
| Percent Change From Baseline in Triglycerides at Week 24 | Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.) | Baseline, Week 24 |
| Percent Change From Baseline in HDL-C at Week 24 | Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.) | Bseline, Week 24 |
| Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol (VLDL-C) at Week 24 | Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.) | Baseline, Week 24 |
| Hartford |
| Connecticut |
| 06102 |
| United States |
| Research Site | Washington D.C. | District of Columbia | 20005 | United States |
| Research Site | Washington D.C. | District of Columbia | 20007 | United States |
| Research Site | Washington D.C. | District of Columbia | 20037 | United States |
| Research Site | Miami | Florida | 33136 | United States |
| Research Site | Tampa | Florida | 33602 | United States |
| Research Site | Vero Beach | Florida | 32960 | United States |
| Research Site | Augusta | Georgia | 30912 | United States |
| Research Site | Berkley | Michigan | 48072 | United States |
| Research Site | Detroit | Michigan | 48202 | United States |
| Research Site | Southfield | Michigan | 48075 | United States |
| Research Site | Minneapolis | Minnesota | 55415 | United States |
| Research Site | St Louis | Missouri | 63110 | United States |
| Research Site | Camden | New Jersey | 08103 | United States |
| Research Site | Albany | New York | 12208 | United States |
| Research Site | New York | New York | 10029 | United States |
| Research Site | The Bronx | New York | 10467 | United States |
| Research Site | Cincinnati | Ohio | 45267 | United States |
| Research Site | Falls Church | Virginia | 22042 | United States |
| Research Site | Darlinghurst | New South Wales | 2010 | Australia |
| Research Site | East Sydney | New South Wales | 2010 | Australia |
| Research Site | Sydney | New South Wales | 2010 | Australia |
| Research Site | Fortitude Valley | Queensland | 4006 | Australia |
| Research Site | Melbourne | Victoria | 3004 | Australia |
| Research Site | Prahran | Victoria | 3181 | Australia |
| Research Site | Antwerp | 2000 | Belgium |
| Research Site | Brussels | 1000 | Belgium |
| Research Site | Ghent | 9000 | Belgium |
| Research Site | São Paulo | São Paulo | 04121-000 | Brazil |
| Research Site | Rio de Janeiro | 21040-900 | Brazil |
| Research Site | São Paulo | 05403-000 | Brazil |
| Research Site | Calgary | Alberta | T2R 0X7 | Canada |
| Research Site | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Research Site | Hamilton | Ontario | L8S 1A4 | Canada |
| Research Site | Montreal | Quebec | H4A 3T2 | Canada |
| Research Site | Québec | Quebec | G1V 4G2 | Canada |
| Research Site | Bordeaux | 33075 | France |
| Research Site | Lyon | 69317 | France |
| Research Site | Montpellier | 34295 | France |
| Research Site | Nantes | 44093 | France |
| Research Site | Paris | 75475 | France |
| Research Site | Paris | 75571 | France |
| Research Site | Paris | 75651 | France |
| Research Site | Athens | 10676 | Greece |
| Research Site | Athens | 11527 | Greece |
| Research Site | Athens | 12462 | Greece |
| Research Site | Athens | 16121 | Greece |
| Research Site | Thessaloniki | 54636 | Greece |
| Research Site | Bologna | 40138 | Italy |
| Research Site | Genova | 16132 | Italy |
| Research Site | Milan | 20157 | Italy |
| Research Site | Modena | 41100 | Italy |
| Research Site | Pisa | 56124 | Italy |
| Research Site | Roma | 00149 | Italy |
| Research Site | Warsaw | 01-201 | Poland |
| Research Site | Almada | 2801-951 | Portugal |
| Research Site | Aveiro | 3814-501 | Portugal |
| Research Site | Coimbra | 3000-075 | Portugal |
| Research Site | Porto | 4200-319 | Portugal |
| Research Site | Brasov | 500174 | Romania |
| Research Site | Bucharest | 021105 | Romania |
| Research Site | Constanța | 900708 | Romania |
| Research Site | Timișoara | 300310 | Romania |
| Research Site | Pretoria | Gauteng | 0122 | South Africa |
| Research Site | Westdene | Gauteng | 2092 | South Africa |
| Research Site | Bloemfontein | 9301 | South Africa |
| Research Site | Barcelona | Catalonia | 08035 | Spain |
| Research Site | Barcelona | Catalonia | 08036 | Spain |
| Research Site | Madrid | 28040 | Spain |
| Research Site | Madrid | 28046 | Spain |
| Research Site | Geneva | 1211 | Switzerland |
| Research Site | Lausanne | 1011 | Switzerland |
| Research Site | Lugano | 6900 | Switzerland |
| Research Site | Zurich | 8091 | Switzerland |
| Research Site | London | SE1 9RT | United Kingdom |
| Research Site | London | SW10 9NH | United Kingdom |
| Research Site | London | W2 1NY | United Kingdom |
| Boccara F, Kumar P, Caramelli B, Calmy A, Lopez JAG, Bray S, Cyrille M, Rosenson RS. Evolocumab treatment in patients with HIV and hypercholesterolemia/mixed dyslipidemia: BEIJERINCK study design and baseline characteristics. Am Heart J. 2020 Feb;220:203-212. doi: 10.1016/j.ahj.2019.11.004. Epub 2019 Nov 12. |
| 35025817 | Background | Boccara F, Caramelli B, Calmy A, Kumar P, Lopez JAG, Bray S, Cyrille M, Rosenson RS; investigators of the BEIJERINCK study. Long-term effects of evolocumab in participants with HIV and dyslipidemia: results from the open-label extension period. AIDS. 2022 Apr 1;36(5):675-682. doi: 10.1097/QAD.0000000000003175. |
| 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. |
Double-blind evolocumab SC injection QM for 24 weeks in the double-blind period, followed by open-label evolocumab 420 mg SC QM for 24 weeks in the open-label period. |
|
| Randomized and Treated |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
| Open-Label Period |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Double-Blind Placebo | Double-blind placebo SC injection QM for 24 weeks in the double-blind period. |
| BG001 | Double-Blind Evolocumab | Double-blind evolocumab SC injection QM for 24 weeks in the double-blind period. |
| 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 | Count of Participants | Participants |
| ||||||||||||||||
| Stratification Factor: Statin Use at Baseline | Count of Participants | Participants |
| ||||||||||||||||
| Stratification Factor: Hepatitis C Virus (HCV) Status at Baseline | Count of Participants | Participants |
| ||||||||||||||||
| Low-Density Lipoprotein Cholesterol (LDL-C) | participants with a baseline assessment | Mean | Standard Deviation | mg/dL |
|
| 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 in LDL-C at Week 24 | Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.) | Full Analysis Set: randomized participants who received at least 1 dose of investigational product. Participants with an assessment. | Posted | Least Squares Mean | Standard Error | percent change | Baseline, Week 24 |
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| Secondary | Change From Baseline in LDL-C at Week 24 | Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.) | Full Analysis Set: randomized participants who received at least 1 dose of investigational product. Participants with an assessment. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline, Week 24 |
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| Secondary | Percentage of Participants Acheiving LDL-C < 70 mg/dL (1.8 mmol/L) at Week 24 | Full Analysis Set: randomized participants who received at least 1 dose of investigational product. Participants with observed data. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 24 |
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| Secondary | Percentage of Participants With an LDL-C Response (50% Reduction of LDL-C From Baseline) at Week 24 | Full Analysis Set: randomized participants who received at least 1 dose of investigational product. Participants with observed data. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 24 |
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| Secondary | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (HDL-C) at Week 24 | Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.) | Full Analysis Set: randomized participants who received at least 1 dose of investigational product. Participants with an assessment. | Posted | Least Squares Mean | Standard Error | percent change | Baseline, Week 24 |
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| Secondary | Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24 | Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.) | Full Analysis Set: randomized participants who received at least 1 dose of investigational product. Participants with an assessment. | Posted | Least Squares Mean | Standard Error | percent change | Baseline, Week 24 |
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| Secondary | Percent Change From Baseline in Total Cholesterol (TC) at Week 24 | Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.) | Full Analysis Set: randomized participants who received at least 1 dose of investigational product. Participants with an assessment. | Posted | Least Squares Mean | Standard Error | percent change | Baseline, Week 24 |
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| Secondary | Percent Change From Baseline in Lipoprotein(a) (Lp[a]) at Week 24 | Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.) | Full Analysis Set: randomized participants who received at least 1 dose of investigational product. Participants with an assessment. | Posted | Least Squares Mean | Standard Error | percent change | Baseline, Week 24 |
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| Secondary | Percent Change From Baseline in Triglycerides at Week 24 | Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.) | Full Analysis Set: randomized participants who received at least 1 dose of investigational product. Participants with an assessment. | Posted | Least Squares Mean | Standard Error | percent change | Baseline, Week 24 |
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| Secondary | Percent Change From Baseline in HDL-C at Week 24 | Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.) | Full Analysis Set: randomized participants who received at least 1 dose of investigational product. Participants with an assessment. | Posted | Least Squares Mean | Standard Error | percent change | Bseline, Week 24 |
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| Secondary | Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol (VLDL-C) at Week 24 | Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.) | Full Analysis Set: randomized participants who received at least 1 dose of investigational product. Participants with an assessment. | Posted | Least Squares Mean | Standard Error | percent change | Baseline, Week 24 |
|
|
Double-blind Treatment (DBT) Period: From randomization (for all-cause mortality) or first dose of study drug (for adverse events) to up to week 24. Open-label Extension (OLE) Period: From the start of the OLE (week 24) to end of study (week 52) for all-cause mortality; and from first dose of study drug in the OLE up to 30 days after last dose, or end of study, whichever was earlier, for adverse events.
Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants randomized in the DBT Period as well as for all participants who entered into the OLE Period.
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 | Double-Blind Placebo | Double-blind placebo SC injection QM for 24 weeks. | 0 | 157 | 8 | 157 | 41 | 157 |
| EG001 | Double-Blind Evolocumab | Double-blind evolocumab SC injection QM for 24 weeks. | 0 | 310 | 10 | 307 | 78 | 307 |
| EG002 | Double-Blind Placebo/Open-Label Evolocumab | Participants originally randomized to placebo in the double-blind period then received open-label evolocumab 420 mg SC QM for 24 weeks. | 0 | 152 | 8 | 152 | 23 | 152 |
| EG003 | Double-Blind Evolocumab/Open-Label Evolocumab | Participants originally randomized to evolocumab in the double-blind period then received open-label evolocumab 420 mg SC QM for 24 weeks. | 2 | 303 | 14 | 299 | 50 | 299 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pericarditis constrictive | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Gastroenteritis bacterial | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Helicobacter gastritis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Respiratory syncytial virus bronchitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Brain contusion | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Basosquamous carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Bladder cancer stage 0, with cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Hair follicle tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Renal cell carcinoma stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Sarcomatoid carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Cerebral artery thrombosis | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Lipohypertrophy | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | 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 | Jan 20, 2019 | Jun 25, 2020 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D015658 | HIV Infections |
| D006949 | Hyperlipidemias |
| C566337 | Hypercholesterolemia, Autosomal Dominant, 3 |
| D007266 | Inhibition, Psychological |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| C577155 | evolocumab |
Not provided
Not provided
Not provided
| Withdrawal by Subject |
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