HypercholesterolemiaPhase 3NCT02304484
Open-label Extension (OLE) Study to Assess Safety and Efficacy of Evolocumab
A Phase 3 study testing Evolocumab in people with Hypercholesterolemia, run by Amgen at 126 sites in 29 countries.
Trial summary
The purpose of this study was to characterize the safety and tolerability of long-term administration of evolocumab in adults with known coronary artery disease and hypercholesterolemia. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Evolocumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 770 participants
- Where
- 126 sitesin 29 countries
- Study dates
- 24 Nov 2014to 9 Mar 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completed week 80 of study 20120153 (NCT01813422).
Who cannot join
- Did not complete investigational product in the 20120153 parent study
- Have an unstable medical condition, in the judgment of the investigator
- Known sensitivity to any of the products to be administered during dosing
- Currently enrolled in another investigational device or drug study (excluding evolocumab (AMG 145) parent study), or less than 30 days since ending another investigational device or drug study(s),or receiving other investigational agent(s)
Trial locations and contacts
126 sites in 29 countries.
126 sites in 29 countries
United States24 sites
Research Site
Amarillo, Texas, 79106
Research Site
Bay City, Michigan, 48708
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Bethesda, Maryland, 20814
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Canton, Ohio, 44710
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Columbia, Maryland, 21044
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Columbia, Missouri, 65212
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Covington, Louisiana, 70433
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Dallas, Texas, 75216
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Duluth, Minnesota, 55805
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Fargo, North Dakota, 58122
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Huntsville, Alabama, 35801
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Jacksonville, Florida, 32216
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Lexington, Kentucky, 40536
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Long Beach, California, 90822
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Midland, Michigan, 48670
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Mobile, Alabama, 36608
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Munster, Indiana, 46321
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Oak Ridge, Tennessee, 37830
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Ridgewood, New Jersey, 07450
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Saint Cloud, Minnesota, 56303
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San Diego, California, 92161
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Toledo, Ohio, 43614
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Torrance, California, 90502
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Wichita Falls, Texas, 76301
Canada11 sites
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Calgary, Alberta, T2N 4Z6
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Halifax, Nova Scotia, B3H 3A7
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Laval, Quebec, H7M 3L9
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London, Ontario, N6A 5A5
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Montreal, Quebec, H1T 2M4
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Québec, Quebec, G1V 4G5
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St. John's, Newfoundland and Labrador, A1B 3V6
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Toronto, Ontario, M5B 1W8
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Toronto, Ontario, M5G 2C4
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Victoria, British Columbia, V8R 4R2
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Winnipeg, Manitoba, R2H 2A6
Australia9 sites
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Adelaide, South Australia, 5000
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Chermside, Queensland, 4032
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Epping, Victoria, 3076
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Footscray, Victoria, 3011
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Fullarton, South Australia, 5063
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Herston, Queensland, 4029
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Liverpool, New South Wales, 2170
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Nedlands, Western Australia, 6009
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New Lambton Heights, New South Wales, 2305
Netherlands9 sites
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Alkmaar, 1815 JD
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Amsterdam, 1081 HV
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Amsterdam, 1091 AC
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Leeuwarden, 8934 AD
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Nijmegen, 6532 SZ
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Rotterdam, 3079 DZ
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Tilburg, 5042 AD
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Utrecht, 3508 GZ
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Zwolle, 8025 AB
Poland6 sites
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Chrzanów, 32-500
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Kędzierzyn-Koźle, 47-200
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Krakow, 31-202
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Krakow, 31-501
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Lodz, 90-549
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Warsaw, 04-628
Spain6 sites
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Barcelona, Catalonia, 08035
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Gijón, Principality of Asturias, 33394
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L'Hospitalet de Llobregat, Catalonia, 08907
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Madrid, 28034
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Madrid, 28046
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Málaga, Andalusia, 29010
Belgium5 sites
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Antwerp, 2020
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Edegem, 2650
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Genk, 3600
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Hasselt, 3500
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Lodelinsart, 6042
France5 sites
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Besançon, 25030
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Chambray-lès-Tours, 37170
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Marseille, 13385
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Paris, 75015
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Pessac, 33604
Hungary5 sites
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Budapest, 1023
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Budapest, 1122
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Budapest, 1134
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Debrecen, 4032
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Szeged, 6725
Argentina4 sites
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Córdoba, Córdoba Province, X5016KEH
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Córdoba, X5003DCE
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Córdoba, X5021FPI
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La Plata, Buenos Aires, B1906EHD
Czechia4 sites
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Brno, 625 00
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Hradec Králové, 500 05
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Prague, 128 08
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Zlín, 762 75
Italy4 sites
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Novara, 28100
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Rozzano MI, 20089
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Sesto San Giovanni (MI), 20099
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Torino, 10154
Mexico4 sites
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Aguascalientes, 20230
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Culiacán, Sinaloa, 80230
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Guadalajara, Jalisco, 44670
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San Luis Potosí City, San Luis Potosí, 78240
Russia4 sites
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Kemerovo, 650002
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Moscow, 101990
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Moscow, 119991
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Moscow, 121552
South Korea4 sites
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Daejeon, 301-723
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Seongnam-si, Gyeonggi-do, 463-707
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Seoul, 130-872
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Seoul, 156-707
Greece3 sites
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Athens, 11527
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Athens, 14561
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Heraklion, 71110
South Africa3 sites
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Centurion, Gauteng, 0157
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Kuils River, Western Cape, 7580
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Sunninghill, Gauteng, 2157
Brazil2 sites
Research Site
Porto Alegre, Rio Grande do Sul, 90620-001
Research Site
São Paulo, 05403-000
Malaysia2 sites
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George Town, 10050
Research Site
Kuantan, Pahang, 25100
About this study
Official title: A Multicenter, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of Evolocumab
The purpose of this study was to characterize the safety and tolerability of long-term administration of evolocumab in adults with known coronary artery disease and hypercholesterolemia.
- Conditions
- Hypercholesterolemia
- Being tested
- Evolocumab
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvolocumabBiological
Also called AMG 145, Repatha
Administered by subcutaneous injection once a month
| Study group | Role | What they receive |
|---|---|---|
| Evolocumab | Experimental | Participants received 420 mg evolocumab once a month for up to 2 years. Receives: Biological: Evolocumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
The severity of each adverse event (AE) was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 criteria, where Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe or medically significant AE, Grade 4 = Life-threatening consequences, and Grade 5 = death related to AE.
An adverse device effect was defined as any adverse event related to the use of a medical device (autoinjector/pen or automated mini doser [AMD]), including but not limited to, AEs resulting from insufficient or inadequate Instructions for Use, AEs resulting from any malfunction of the device, or AEs resulting from use error or from intentional misuse of the device.
Measured: From first dose of evolocumab up to 30 days after the last dose, or end of study, whichever was earlier, up to 108 weeks.
Secondary outcomes (1)
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Measured: Baseline (of study 20120153) and weeks 0, 4, 12, 24, 36, 48, 52, 76, and 104 of study 20140128
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study start24 Nov 2014
- Primary completion9 Mar 2018
- Study completion9 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 770 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304484
- Sponsor's protocol ID
- 20140128
- Other IDs
- 2014-001524-30, 2014
- Status last verified
- Feb 2019
- First submitted
- 7 Oct 2014
- Last updated
- 19 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of Evolocumab
- ClinicalTrials.gov ID
- NCT02304484
- Acronym / sponsor ID
- 20140128
- Conditions
- Hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 770 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2014 (actual)
- Primary completion
- 9 Mar 2018 (actual)
- Study completion
- 9 Mar 2018 (actual)
- First posted
- 2 Dec 2014 (estimated)
- Results
- Posted 19 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to characterize the safety and tolerability of long-term administration of evolocumab in adults with known coronary artery disease and hypercholesterolemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evolocumab | Experimental | Biological: EvolocumabParticipants received 420 mg evolocumab once a month for up to 2 years. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Completed week 80 of study 20120153 (NCT01813422).
Key exclusion criteria (4 listed)
- Did not complete investigational product in the 20120153 parent study
- Have an unstable medical condition, in the judgment of the investigator
- Known sensitivity to any of the products to be administered during dosing
- Currently enrolled in another investigational device or drug study (excluding evolocumab (AMG 145) parent study), or less than 30 days since ending another investigational device or drug study(s),or receiving other investigational agent(s)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EvolocumabAlso: AMG 145, RepathaAdministered by subcutaneous injection once a month | Biological | Evolocumab |
Primary outcome
Number of Participants With Adverse Events
Time frame: From first dose of evolocumab up to 30 days after the last dose, or end of study, whichever was earlier, up to 108 weeks.
The severity of each adverse event (AE) was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 criteria, where Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe or medically significant AE, Grade 4 = Life-threatening consequences, and Grade 5 = death related to AE. An adverse device effect was defined as any adverse event related to the use of a medical device (autoinjector/pen or automated mini doser [AMD]), including but not limited to, AEs resulting from insufficient or inadequate Instructions for Use, AEs resulting from any malfunction of the device, or AEs resulting from use error or from intentional misuse of the device.
1 secondary outcome
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline (of study 20120153) and weeks 0, 4, 12, 24, 36, 48, 52, 76, and 104 of study 20140128
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
126 sites in 29 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Evolocumab in people with Hypercholesterolemia, run by Amgen at 126 sites in 29 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 126 sites in United States, Canada, Australia, Netherlands, Poland and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (time frame: From first dose of evolocumab up to 30 days after the last dose, or end of study, whichever was earlier, up to 108 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.