DyslipidemiaPhase 3NCT03080935
Fourier Open-label Extension Study in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries
A Phase 3 study testing Evolocumab in people with Dyslipidemia, run by Amgen at 85 sites in 7 countries.
Trial summary
This is a multicenter, open-label extension (OLE) study designed to assess the extended long-term safety of evolocumab in subjects who have completed the FOURIER trial (Study 20110118). Approximately 1600 subjects will be enrolled in this study. This study will continue for 260 weeks (approximately 5 years). Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- Evolocumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 85 sitesin 7 countries
- Study dates
- 13 Mar 2017to 4 Mar 2022
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has provided informed consent prior to initiation of any study-specific activities/procedures.
- Subject had completed FOURIER (Study 20110118) while still receiving assigned Investigational Product.
Who cannot join
- Permanent discontinuation of Investigational Product during FOURIER for any reason including an adverse event or serious adverse event.
- Currently receiving treatment in another investigational device or drug study, or less than 4 weeks since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
- Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge.
- History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
- Subject has known sensitivity to any of the active substances or excipients (eg, sodium acetate) to be administered during dosing.
- Females who are pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment with evolocumab and for an additional 15 weeks after treatment with evolocumab discontinues.
- Female subjects of childbearing potential unwilling to use an acceptable method of effective contraception during treatment and for an additional 15 weeks after the last dose of protocol-required therapies.
Trial locations and contacts
85 sites in 7 countries.
85 sites in 7 countries
Germany17 sites
Universitaets-Herzzentrum Freiburg - Bad Krozingen
Bad Krozingen, 79189
Klinische Forschung Berlin GbR
Berlin, 10787
Vivantes Klinikum Neukölln
Berlin, 12351
Deutsches Rotes Kreuz Kliniken Berlin Köpenick
Berlin, 12559
Deutsches Herzzentrum Berlin
Berlin, 13353
Sankt-Johannes-Hospital
Dortmund, 44137
Gesellschaft fur Wissens und Technologietransfer der Technischen Uni Dresden
Dresden, 01307
Universitätsklinikum Köln
Köln, 50937
Ambulantes Herzzentrum Kassel
Kassel, 34121
Herz-Gefäß-Zentrum Nymphenburg am Klinikum Dritter Orden
München, 80333
Deutsches Herzzentrum München des Freistaates Bayern
München, 80636
Otto von Guericke Universität Magdeburg
Magdeburg, 39120
Johannes Gutenberg Universität Mainz
Mainz, 55131
Robert Bosch Krankenhaus
Stuttgart, 70376
Universitätsklinikum Ulm
Ulm, 89081
Forschungszentrum Ruhr
Witten, 58455
Helios Universitätsklinikum Wuppertal
Wuppertal, 42117
Belgium16 sites
Algemeen Stedelijk Ziekenhuis Aalst
Aalst, 9300
Onze Lieve Vrouw Ziekenhuis Aalst
Aalst, 9300
Ziekenhuis Netwerk Antwerpen Middelheim
Antwerp, 2020
Ziekenhuis Netwerk Antwerpen Stuivenberg
Antwerp, 2060
Imelda Ziekenhuis vzw
Bonheiden, 2820
Centre Hospitalier Universitaire Brugmann
Brussels, 1020
Cliniques universitaires de Bruxelles Hopital Erasme
Brussels, 1070
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Brussels, 1200
Algemeen Ziekenhuis Sint Lucas
Ghent, 9000
Universitair Ziekenhuis Gent
Ghent, 9000
Medif sprl
Gozée, 6534
Centre Hospitalier Universitaire de Tivoli
La Louvière, 7100
Centres Hospitaliers Jolimont - Hopital de Jolimont
La Louvière, 7100
Centre Hospitalier Regional de la Citadelle
Liège, 4000
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, 4000
Algemeen Ziekenhuis Turnhout
Turnhout, 2300
Denmark14 sites
Aalborg Hospital
Aalborg, 9000
Center for Clinical and Basic Research Aalborg
Aalborg, 9000
Aarhus Universitetshospital
Aarhus N, 8200
Centre for Clinical and Basic Research Ballerup
Ballerup Municipality, 2750
Sydvestjysk Sygehus
Esbjerg, 6700
Frederiksberg/Bispebjerg Hospitaler
Frederiksberg, 2000
Glostrup Hospital
Glostrup Municipality, 2600
Hvidovre Hospital
Hvidovre, 2650
Amager Hospital
København S, 2300
Odense Universitetssygehus
Odense, 5000
Sjaellands Universitetshospital, Roskilde
Roskilde, 4000
Svendborg Sygehus
Svendborg, 5700
Center for Clinical and Basic Research Vejle
Vejle, 7100
Regionshospitalet Viborg
Viborg, 8800
France13 sites
Centre Hospitalier Regional Universitaire de Besancon, Hopital Jean Minjoz
Besançon, 25030
Centre Hospitalier Régional Universitaire de Tours - Hôpital Trousseau
Chambray-lès-Tours, 37170
Hopital Louis Pasteur
Le Coudray, 28630
Centre Hospitalier Regional Universitaire de Montpellier - Hopital Arnaud de Villeneuve
Montpellier, 34295
Centre Hospitalier Universitaire de Nantes - Hopital Guillaume et Rene Laennec
Nantes, 44093
Nouvelles Cliniques Nantaises
Nantes, 44202
Centre Hospitalier Universitaire de Nice - Hopital Pasteur
Nice, 06000
Hopital Lariboisiere
Paris, 75010
Hopital Pitie-Salpetriere
Paris, 75013
Centre Hospitalier de Pau - Hopital Francois Mitterrand
Pau, 64000
Centre Hospitalier Universitaire de Reims - Hopital Robert Debre
Reims, 51100
Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil
Toulouse, 31059
Centre Hospitalier Intercommunal Haute Saone
Vesoul, 70014
Sweden10 sites
Falu Lasarett
Falun, 791 82
Helsingborgs Lasarett
Helsingborg, 252 47
Länssjukhuset Ryhov
Jönköping, 551 85
Sunderby Sjukhus
Luleå, 971 80
Skanes Universitetssjukhus
Lund, 221 85
Capio Citykliniken
Lund, 222 21
Universitetssjukhuset Ã-rebro
Örebro, 701 85
Ostersunds sjukhus
Östersund, 831 83
Akardo MedSite
Stockholm, 117 27
Norrlands Universitetssjukhus
Umeå, 901 85
Italy9 sites
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, 24127
Azienda Ospedaliero Universitaria Careggi
Florence, 50139
Centro Cardiologico Monzino
Milan, 20138
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, 20162
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Palermo, 90146
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
Perugia, 06129
Fondazione Toscana Gabriele Monasterio, Stabilimento Ospedaliero di Pisa
Pisa, 56124
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
Siena, 53100
Portugal6 sites
Hospital Garcia de Orta, EPE
Almada, 2801-951
Centro Hospitalar e Universitario de Coimbra EPE
Coimbra, 3000-075
Centro Hospitalar Cova da Beira, EPE - Hospital Pero da Covilha
Covilha, 6200-251
Hospital Cuf Infante Santo
Lisbon, 1350-352
Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Sao Francisco Xavier
Lisbon, 1449-005
Centro Hospitalar de Setubal EPE Hospital de Sao Bernardo
Setúbal, 2910-446
About this study
Official title: A Multicenter, Open-label, Single-arm, Extension Study to Assess Long-term Safety of Evolocumab Therapy in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries
This is a multicenter, open-label extension (OLE) study designed to assess the extended long-term safety of evolocumab in subjects who have completed the FOURIER trial (Study 20110118). Approximately 1600 subjects will be enrolled in this study. This study will continue for 260 weeks (approximately 5 years).
Read the detailed description
This is a multicenter, open-label extension (OLE) study designed to assess the extended long-term safety of evolocumab in subjects who have completed the FOURIER trial (Study 20110118). FOURIER is a randomized placebo-controlled study of evolocumab, in patients with clinically evident atherosclerotic CVD on stable effective statin therapy. Subjects at sites participating in FOURIER OLE (Study 20160250) who are eligible and have signed the FOURIER OLE informed consent will be enrolled after completion of FOURIER.
The FOURIER OLE study requires laboratory assessments at day 1, week 12, and thereafter approximately every 6 months from day 1; the corresponding blood samples will be processed using a central laboratory.
Upon enrollment in FOURIER OLE study, subjects will receive evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM) according to their preference. Frequency and corresponding dose of administration can be changed at any scheduled time point where evolocumab is supplied to the subject, provided the appropriate supply is available. It is recommended that subjects continue the same background lipid-lowering therapy (LLT), including statin, as taken during FOURIER.
This study will continue for 260 weeks (approximately 5 years). Subjects ending administration of evolocumab should continue study assessments until the end of study. All subjects will be followed and complete procedures/assessments from enrollment through the date of study termination unless the subject has withdrawn consent, irrespective of whether the subject is continuing to receive treatment.
All deaths and cardiovascular events of interest will be reviewed by an independent external Clinical Events Committee (CEC), using standardized definitions.
- Conditions
- Dyslipidemia
- Being tested
- Evolocumab
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvolocumabDrug
Also called AMG 145
Subjects will receive Evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM), according to the subject's preference.
| Study group | Role | What they receive |
|---|---|---|
| Evolocumab | Experimental | Single arm study administering Evolocumab. Receives: Drug: Evolocumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced an Adverse Event
All adverse event summaries for the primary analysis of the primary endpoint (OLE study period only) included all treatment-emergent events reported on the Event electronic case report form (eCRF), including CEC positively reviewed events and disease-related events.
Measured: Up to 5 years
Secondary outcomes (2)
Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit
Measured: Baseline, Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260
Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL
Measured: Baseline, Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start13 Mar 2017
- Primary completion4 Mar 2022
- Study completion4 Mar 2022
Why it stopped: Amgen business decision to close study early
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiaStudies 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
- 1,600 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
- NCT03080935
- Sponsor's protocol ID
- 20160250
- Other IDs
- 2016-004066-26, 2016
- Status last verified
- May 2024
- First submitted
- 10 Mar 2017
- Last updated
- 29 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Publications
O'Donoghue ML, Giugliano RP, Wiviott SD, Atar D, Keech A, Kuder JF, Im K, Murphy SA, Flores-Arredondo JH, Lopez JAG, Elliott-Davey M, Wang B, Monsalvo ML, Abbasi S, Sabatine MS. Long-Term Evolocumab in Patients With Established Atherosclerotic Cardiovascular Disease. Circulation. 2022 Oct 11;146(15):1109-1119. doi: 10.1161/CIRCULATIONAHA.122.061620. Epub 2022 Aug 29.
PubMed 36031810McClintick DJ, O'Donoghue ML, De Ferrari GM, Ferreira J, Ran X, Im K, Lopez JAG, Elliott-Davey M, Wang B, Monsalvo ML, Atar D, Keech A, Giugliano RP, Sabatine MS. Long-Term Efficacy of Evolocumab in Patients With or Without Multivessel Coronary Disease. J Am Coll Cardiol. 2024 Feb 13;83(6):652-664. doi: 10.1016/j.jacc.2023.11.029.
PubMed 38325990Katsiki N, Athyros VG, Mikhailidis DP, Mantzoros C. Proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors: Shaping the future after the further cardiovascular outcomes research with PCSK9 inhibition in subjects with elevated risk (FOURIER) trial. Metabolism. 2017 Sep;74:43-46. doi: 10.1016/j.metabol.2017.04.007. Epub 2017 Apr 20. No abstract available.
PubMed 28477848
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Single-arm, Extension Study to Assess Long-term Safety of Evolocumab Therapy in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries
- ClinicalTrials.gov ID
- NCT03080935
- Acronym / sponsor ID
- 20160250
- Conditions
- Dyslipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Amgen business decision to close study early
- Enrolment
- 1,600 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2017 (actual)
- Primary completion
- 4 Mar 2022 (actual)
- Study completion
- 4 Mar 2022 (actual)
- First posted
- 15 Mar 2017 (actual)
- Results
- Posted 11 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, open-label extension (OLE) study designed to assess the extended long-term safety of evolocumab in subjects who have completed the FOURIER trial (Study 20110118). Approximately 1600 subjects will be enrolled in this study. This study will continue for 260 weeks (approximately 5 years).
Detailed description
This is a multicenter, open-label extension (OLE) study designed to assess the extended long-term safety of evolocumab in subjects who have completed the FOURIER trial (Study 20110118). FOURIER is a randomized placebo-controlled study of evolocumab, in patients with clinically evident atherosclerotic CVD on stable effective statin therapy. Subjects at sites participating in FOURIER OLE (Study 20160250) who are eligible and have signed the FOURIER OLE informed consent will be enrolled after completion of FOURIER.
The FOURIER OLE study requires laboratory assessments at day 1, week 12, and thereafter approximately every 6 months from day 1; the corresponding blood samples will be processed using a central laboratory.
Upon enrollment in FOURIER OLE study, subjects will receive evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM) according to their preference. Frequency and corresponding dose of administration can be changed at any scheduled time point where evolocumab is supplied to the subject, provided the appropriate supply is available. It is recommended that subjects continue the same background lipid-lowering therapy (LLT), including statin, as taken during FOURIER.
This study will continue for 260 weeks (approximately 5 years). Subjects ending administration of evolocumab should continue study assessments until the end of study. All subjects will be followed and complete procedures/assessments from enrollment through the date of study termination unless the subject has withdrawn consent, irrespective of whether the subject is continuing to receive treatment.
All deaths and cardiovascular events of interest will be reviewed by an independent external Clinical Events Committee (CEC), using standardized definitions.
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 | Drug: EvolocumabSingle arm study administering Evolocumab. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject has provided informed consent prior to initiation of any study-specific activities/procedures.
- Subject had completed FOURIER (Study 20110118) while still receiving assigned Investigational Product.
Key exclusion criteria (7 listed)
- Permanent discontinuation of Investigational Product during FOURIER for any reason including an adverse event or serious adverse event.
- Currently receiving treatment in another investigational device or drug study, or less than 4 weeks since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
- Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge.
- History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
- Subject has known sensitivity to any of the active substances or excipients (eg, sodium acetate) to be administered during dosing.
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 145Subjects will receive Evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM), according to the subject's preference. | Drug | Evolocumab |
Primary outcome
Number of Participants Who Experienced an Adverse Event
Time frame: Up to 5 years
All adverse event summaries for the primary analysis of the primary endpoint (OLE study period only) included all treatment-emergent events reported on the Event electronic case report form (eCRF), including CEC positively reviewed events and disease-related events.
2 secondary outcomes
Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit
Time frame: Baseline, Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260
Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL
Time frame: Baseline, Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 36031810O'Donoghue ML, Giugliano RP, Wiviott SD, Atar D, Keech A, Kuder JF, Im K, Murphy SA, Flores-Arredondo JH, Lopez JAG, Elliott-Davey M, Wang B, Monsalvo ML, Abbasi S, Sabatine MS. Long-Term Evolocumab in Patients With Established Atherosclerotic Cardiovascular Disease. Circulation. 2022 Oct 11;146(15):1109-1119. doi: 10.1161/CIRCULATIONAHA.122.061620. Epub 2022 Aug 29.
- Background: PubMed 38325990McClintick DJ, O'Donoghue ML, De Ferrari GM, Ferreira J, Ran X, Im K, Lopez JAG, Elliott-Davey M, Wang B, Monsalvo ML, Atar D, Keech A, Giugliano RP, Sabatine MS. Long-Term Efficacy of Evolocumab in Patients With or Without Multivessel Coronary Disease. J Am Coll Cardiol. 2024 Feb 13;83(6):652-664. doi: 10.1016/j.jacc.2023.11.029.
- Derived from this study: PubMed 28477848Katsiki N, Athyros VG, Mikhailidis DP, Mantzoros C. Proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors: Shaping the future after the further cardiovascular outcomes research with PCSK9 inhibition in subjects with elevated risk (FOURIER) trial. Metabolism. 2017 Sep;74:43-46. doi: 10.1016/j.metabol.2017.04.007. Epub 2017 Apr 20. No abstract available.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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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
85 sites in 7 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 Dyslipidemia, run by Amgen at 85 sites in 7 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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 85 sites in Germany, Belgium, Denmark, France, Sweden and 2 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 11 Jan 2023). 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 Who Experienced an Adverse Event (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03080935, which also lists 3 linked publications.
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 29 May 2024.