Chronic DiseaseSMIWizardNCT02451670
Reducing Cardiovascular Risk in Adults With Serious Mental Illness
A study testing Prioritized Clinical Decision Support in people with Chronic Disease and Mental Disorder, run by HealthPartners Institute at 3 sites in United States.
Trial summary
This purpose of this study is to adapt, implement and test the ability of a sophisticated point-of-care electronic health record-based clinical decision support that identifies and prioritizes all available evidence-based treatment options to reduce cardiovascular risk in patients with serious mental illness. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Disease, Mental Disorder, Health Behavior
- What is being tested?
- Prioritized Clinical Decision Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,347 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Jan 2016to 19 Sep 2018
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Serious Mental Illness diagnosis
- Age 18-75
- Index visit during the enrollment period
- First primary care visit where patient was not at goal for at least one of the six cardiovascular risk factor areas, and patient was not pregnant
- One or more post-index visits during the intervention period
Who cannot join
- No Serious Mental Illness diagnosis
- Under age 18 or over age 75
- In hospice or nursing home
- At goal for all cardiovascular risk 6 areas
- On research exclusion list
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Essentia Health
Duluth, Minnesota, 55805
Park Nicollet Clinic
Minneapolis, Minnesota, 55416
HealthPartners
Minneapolis, Minnesota, 55425
About this study
Official title: Reducing Cardiovascular Risk in Adults With Serious Mental Illness Using an Electronic Medical Record-based Clinical Decision Support
This purpose of this study is to adapt, implement and test the ability of a sophisticated point-of-care electronic health record-based clinical decision support that identifies and prioritizes all available evidence-based treatment options to reduce cardiovascular risk in patients with serious mental illness.
Read the detailed description
This study adapted a point-of-care electronic health record-based clinical decision support system (The Cardiovascular Wizard) to help primary care providers identify, provide appropriate care for, and control cardiovascular risk factors for patients with serious mental illness (bipolar disorder, schizophrenia, schizo-affective disorder). The Cardiovascular Wizard is designed to educate primary care providers about the increased risk of cardiovascular disease and mortality in people with serious mental illness, identify elevated cardiovascular risk factors in patients with serious mental illness, identify elevated cardiovascular risk factors in patients with serious mental illness, prioritize these cardiovascular risk based on how much improvement in cardiovascular risk a patient would experience if the cardiovascular risk factor was adequately addressed, recommend specific medications and other interventions to decrease each elevated cardiovascular risk factor, and provide this information in an easy-to-understand format for both patients with serious mental illness and their primary care providers.
The Cardiovascular Wizard was printed in intervention clinics and (i) compiled lab data (most recent glycated hemoglobin, systolic blood pressure and low-density lipoprotein levels), body mass index, smoking status, and aspirin use, (ii) calculated a modifiable 10 year cardiovascular risk for stroke or heart attack using the American College of Cardiology/American Heart Association 10-year atherosclerotic cardiovascular disease risk equation, (iii) prioritized clinical domains based on the absolute risk reduction for each component, (iv) compiled information related to liver and renal function, creatinine kinase level, and previous diagnoses (Congestive Heart Failure, Cardiovascular Disease, Diabetes Mellitus, and (v) provided recommendations for intensification of therapy for glycated hemoglobin, systolic blood pressure, and/or low-density lipoproteins if not at goal. Recommendations were based on evidence-based protocols including Joint National Committee, American Diabetes Association, and the Institute for Clinical Systems Improvement.
- Being tested
- Prioritized Clinical Decision Support
- Medical subject headings
- Chronic Disease, Mental Disorders, Health Behavior, Bipolar Disorder, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prioritized Clinical Decision SupportBehavioural
After entry of blood pressure data at all primary care visits, relevant electronic health record data were automatically extracted, encrypted and processed through Web-based clinical algorithms that determined if the patient met intervention eligibility criteria. In intervention clinics, the rooming staff received a best practice alert and printed patient and primary care provider versions of the clinical decision support that identified evidence-based treatment options for any uncontrolled cardiovascular risk factors and prioritized treatment recommendations based on potential cardiovascular risk reduction. Cardiovascular risk factors addressed in study participants were control of lipids, blood pressure, weight, tobacco, glucose and appropriate aspirin use. In control clinics, rooming staff did not receive a best practice alert and patients and primary care providers did not receive and were not able to access the clinical decision support.
| Study group | Role | What they receive |
|---|---|---|
| Prioritized Clinical Decision Support | Experimental | Patients receiving care in clinics randomized to the intervention arm of the study and their primary care providers were presented with patient-specific written advice as to prioritized treatment and lifestyle changes that could reduce their cardiovascular risk, prompted by an electronic health record-based alert during their primary care visit. Receives: Behavioral: Prioritized Clinical Decision Support |
| Usual Care | No intervention | Patients receiving care in clinics randomized to the usual care arm of the study and their providers were not presented with the prioritized clinical decision support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predicted Annual Rate of Change in 10 Year Risk of Fatal or Nonfatal Heart Attack or Stroke
A modifiable risk component for each cardiovascular risk factor not at optimal goal at the time of each encounter was calculated as the difference between total 10-year atherosclerotic cardiovascular disease risk with the patient's actual values and the goal value. Total modifiable cardiovascular risk was calculated by summing the modifiable cardiovascula risk components across cardiovascular risk factors not at optimal goal at the time of the encounter, and was calculated for each enrolled patient at the index visit and each subsequent encounter during the intervention period. Annual rate of change in modifiable cardiovascular risk was estimated from all patient encounters. A comparison of the difference in model-estimated rate of change in modifiable cardiovascular risk at 12 months post-index tested the primary efficacy hypothesis.
Measured: Index to 12 months post index visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study start20 Jan 2016
- Primary completion19 Sep 2018
- Study completion19 Sep 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.
- Publications (56)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinics have been randomized into a treatment and a control arm.
- Masking
- None (open label)
- Enrolment
- 10,347 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Essentia Health, National Institute of Mental Health (NIMH), Park Nicollet Clinic
- Responsible party
- Sponsor
- Investigators
- Rebecca C Rossom, MD, Principal investigator, HealthPartners Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02451670
- Sponsor's protocol ID
- A13-154
- Other IDs
- U19MH092201
- Acronym
- SMIWizard
- Status last verified
- Mar 2019
- First submitted
- 18 May 2015
- Last updated
- 5 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Weiner M, Warren L, Fiedorowicz JG. Cardiovascular morbidity and mortality in bipolar disorder. Ann Clin Psychiatry. 2011 Feb;23(1):40-7.
PubMed 21318195Osborn DP, Levy G, Nazareth I, Petersen I, Islam A, King MB. Relative risk of cardiovascular and cancer mortality in people with severe mental illness from the United Kingdom's General Practice Rsearch Database. Arch Gen Psychiatry. 2007 Feb;64(2):242-9. doi: 10.1001/archpsyc.64.2.242.
PubMed 17283292De Hert M, Dekker JM, Wood D, Kahl KG, Holt RI, Moller HJ. Cardiovascular disease and diabetes in people with severe mental illness position statement from the European Psychiatric Association (EPA), supported by the European Association for the Study of Diabetes (EASD) and the European Society of Cardiology (ESC). Eur Psychiatry. 2009 Sep;24(6):412-24. doi: 10.1016/j.eurpsy.2009.01.005. Epub 2009 Aug 13.
PubMed 19682863O'Connor PJ, Crain AL, Rush WA, Sperl-Hillen JM, Gutenkauf JJ, Duncan JE. Impact of an electronic medical record on diabetes quality of care. Ann Fam Med. 2005 Jul-Aug;3(4):300-6. doi: 10.1370/afm.327.
PubMed 16046561Osby U, Correia N, Brandt L, Ekbom A, Sparen P. Mortality and causes of death in schizophrenia in Stockholm county, Sweden. Schizophr Res. 2000 Sep 29;45(1-2):21-8. doi: 10.1016/s0920-9964(99)00191-7.
PubMed 10978869Hennekens CH, Hennekens AR, Hollar D, Casey DE. Schizophrenia and increased risks of cardiovascular disease. Am Heart J. 2005 Dec;150(6):1115-21. doi: 10.1016/j.ahj.2005.02.007.
PubMed 16338246Dixon L, Postrado L, Delahanty J, Fischer PJ, Lehman A. The association of medical comorbidity in schizophrenia with poor physical and mental health. J Nerv Ment Dis. 1999 Aug;187(8):496-502. doi: 10.1097/00005053-199908000-00006.
PubMed 10463067Davidson S, Judd F, Jolley D, Hocking B, Thompson S, Hyland B. Cardiovascular risk factors for people with mental illness. Aust N Z J Psychiatry. 2001 Apr;35(2):196-202. doi: 10.1046/j.1440-1614.2001.00877.x.
PubMed 11284901Druss BG, Bradford WD, Rosenheck RA, Radford MJ, Krumholz HM. Quality of medical care and excess mortality in older patients with mental disorders. Arch Gen Psychiatry. 2001 Jun;58(6):565-72. doi: 10.1001/archpsyc.58.6.565.
PubMed 11386985Trangle M, Gary M, Paul G, Christensen R. Minnesota 10 by 10. Reducing morbidity and mortality in people with serious mental illnesses. Minn Med. 2010 Jun;93(6):38-41.
PubMed 20827954Goff DC, Sullivan LM, McEvoy JP, Meyer JM, Nasrallah HA, Daumit GL, Lamberti S, D'Agostino RB, Stroup TS, Davis S, Lieberman JA. A comparison of ten-year cardiac risk estimates in schizophrenia patients from the CATIE study and matched controls. Schizophr Res. 2005 Dec 1;80(1):45-53. doi: 10.1016/j.schres.2005.08.010. Epub 2005 Sep 28.
PubMed 16198088Newcomer JW. Medical risk in patients with bipolar disorder and schizophrenia. J Clin Psychiatry. 2006;67 Suppl 9:25-30; discussion 36-42.
PubMed 16965186Kilbourne AM, Cornelius JR, Han X, Pincus HA, Shad M, Salloum I, Conigliaro J, Haas GL. Burden of general medical conditions among individuals with bipolar disorder. Bipolar Disord. 2004 Oct;6(5):368-73. doi: 10.1111/j.1399-5618.2004.00138.x.
PubMed 15383128Birkenaes AB, Opjordsmoen S, Brunborg C, Engh JA, Jonsdottir H, Ringen PA, Simonsen C, Vaskinn A, Birkeland KI, Friis S, Sundet K, Andreassen OA. The level of cardiovascular risk factors in bipolar disorder equals that of schizophrenia: a comparative study. J Clin Psychiatry. 2007 Jun;68(6):917-23. doi: 10.4088/jcp.v68n0614.
PubMed 17592917Wong CK, Tang EW, Herbison P, Birmingham B, Barclay L, Fu SY. Pre-existent depression in the 2 weeks before an acute coronary syndrome can be associated with delayed presentation of the heart attack. QJM. 2008 Feb;101(2):137-44. doi: 10.1093/qjmed/hcm153. Epub 2008 Jan 10.
PubMed 18187481
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Cardiovascular Risk in Adults With Serious Mental Illness Using an Electronic Medical Record-based Clinical Decision Support
- ClinicalTrials.gov ID
- NCT02451670
- Acronym / sponsor ID
- SMIWizard / A13-154
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,347 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- Essentia Health, National Institute of Mental Health (NIMH), Park Nicollet Clinic
- Study start
- 20 Jan 2016 (actual)
- Primary completion
- 19 Sep 2018 (actual)
- Study completion
- 19 Sep 2018 (actual)
- First posted
- 22 May 2015 (estimated)
- Results
- Posted 5 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This purpose of this study is to adapt, implement and test the ability of a sophisticated point-of-care electronic health record-based clinical decision support that identifies and prioritizes all available evidence-based treatment options to reduce cardiovascular risk in patients with serious mental illness.
Detailed description
This study adapted a point-of-care electronic health record-based clinical decision support system (The Cardiovascular Wizard) to help primary care providers identify, provide appropriate care for, and control cardiovascular risk factors for patients with serious mental illness (bipolar disorder, schizophrenia, schizo-affective disorder). The Cardiovascular Wizard is designed to educate primary care providers about the increased risk of cardiovascular disease and mortality in people with serious mental illness, identify elevated cardiovascular risk factors in patients with serious mental illness, identify elevated cardiovascular risk factors in patients with serious mental illness, prioritize these cardiovascular risk based on how much improvement in cardiovascular risk a patient would experience if the cardiovascular risk factor was adequately addressed, recommend specific medications and other interventions to decrease each elevated cardiovascular risk factor, and provide this information in an easy-to-understand format for both patients with serious mental illness and their primary care providers.
The Cardiovascular Wizard was printed in intervention clinics and (i) compiled lab data (most recent glycated hemoglobin, systolic blood pressure and low-density lipoprotein levels), body mass index, smoking status, and aspirin use, (ii) calculated a modifiable 10 year cardiovascular risk for stroke or heart attack using the American College of Cardiology/American Heart Association 10-year atherosclerotic cardiovascular disease risk equation, (iii) prioritized clinical domains based on the absolute risk reduction for each component, (iv) compiled information related to liver and renal function, creatinine kinase level, and previous diagnoses (Congestive Heart Failure, Cardiovascular Disease, Diabetes Mellitus, and (v) provided recommendations for intensification of therapy for glycated hemoglobin, systolic blood pressure, and/or low-density lipoproteins if not at goal. Recommendations were based on evidence-based protocols including Joint National Committee, American Diabetes Association, and the Institute for Clinical Systems Improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Clinics have been randomized into a treatment and a control arm.
| Arm | Type | Receives |
|---|---|---|
| Prioritized Clinical Decision Support | Experimental | Behavioral: Prioritized Clinical Decision SupportPatients receiving care in clinics randomized to the intervention arm of the study and their primary care providers were presented with patient-specific written advice as to prioritized treatment and lifestyle changes that could reduce their cardiovascular risk, prompted by an electronic health record-based alert during their primary care visit. |
| Usual Care | No intervention | –Patients receiving care in clinics randomized to the usual care arm of the study and their providers were not presented with the prioritized clinical decision support. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Serious Mental Illness diagnosis
- Age 18-75
- Index visit during the enrollment period
- First primary care visit where patient was not at goal for at least one of the six cardiovascular risk factor areas, and patient was not pregnant
- One or more post-index visits during the intervention period
Key exclusion criteria (5 listed)
- No Serious Mental Illness diagnosis
- Under age 18 or over age 75
- In hospice or nursing home
- At goal for all cardiovascular risk 6 areas
- On research exclusion list
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 |
|---|---|---|
| Prioritized Clinical Decision SupportAfter entry of blood pressure data at all primary care visits, relevant electronic health record data were automatically extracted, encrypted and processed through Web-based clinical algorithms that determined if the patient met intervention eligibility criteria. In intervention clinics, the rooming staff received a best practice alert and printed patient and primary care provider versions of the clinical decision support that identified evidence-based treatment options for any uncontrolled cardiovascular risk factors and prioritized treatment recommendations based on potential cardiovascular risk reduction. Cardiovascular risk factors addressed in study participants were control of lipids, blood pressure, weight, tobacco, glucose and appropriate aspirin use. In control clinics, rooming staff did not receive a best practice alert and patients and primary care providers did not receive and were not able to access the clinical decision support. | Behavioural | Prioritized Clinical Decision Support |
Primary outcome
Predicted Annual Rate of Change in 10 Year Risk of Fatal or Nonfatal Heart Attack or Stroke
Time frame: Index to 12 months post index visit
A modifiable risk component for each cardiovascular risk factor not at optimal goal at the time of each encounter was calculated as the difference between total 10-year atherosclerotic cardiovascular disease risk with the patient's actual values and the goal value. Total modifiable cardiovascular risk was calculated by summing the modifiable cardiovascula risk components across cardiovascular risk factors not at optimal goal at the time of the encounter, and was calculated for each enrolled patient at the index visit and each subsequent encounter during the intervention period. Annual rate of change in modifiable cardiovascular risk was estimated from all patient encounters. A comparison of the difference in model-estimated rate of change in modifiable cardiovascular risk at 12 months post-index tested the primary efficacy hypothesis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21318195Weiner M, Warren L, Fiedorowicz JG. Cardiovascular morbidity and mortality in bipolar disorder. Ann Clin Psychiatry. 2011 Feb;23(1):40-7.
- Background: PubMed 17283292Osborn DP, Levy G, Nazareth I, Petersen I, Islam A, King MB. Relative risk of cardiovascular and cancer mortality in people with severe mental illness from the United Kingdom's General Practice Rsearch Database. Arch Gen Psychiatry. 2007 Feb;64(2):242-9. doi: 10.1001/archpsyc.64.2.242.
- Background: PubMed 19682863De Hert M, Dekker JM, Wood D, Kahl KG, Holt RI, Moller HJ. Cardiovascular disease and diabetes in people with severe mental illness position statement from the European Psychiatric Association (EPA), supported by the European Association for the Study of Diabetes (EASD) and the European Society of Cardiology (ESC). Eur Psychiatry. 2009 Sep;24(6):412-24. doi: 10.1016/j.eurpsy.2009.01.005. Epub 2009 Aug 13.
- Background: PubMed 16046561O'Connor PJ, Crain AL, Rush WA, Sperl-Hillen JM, Gutenkauf JJ, Duncan JE. Impact of an electronic medical record on diabetes quality of care. Ann Fam Med. 2005 Jul-Aug;3(4):300-6. doi: 10.1370/afm.327.
- Background: PubMed 10978869Osby U, Correia N, Brandt L, Ekbom A, Sparen P. Mortality and causes of death in schizophrenia in Stockholm county, Sweden. Schizophr Res. 2000 Sep 29;45(1-2):21-8. doi: 10.1016/s0920-9964(99)00191-7.
- Background: PubMed 16338246Hennekens CH, Hennekens AR, Hollar D, Casey DE. Schizophrenia and increased risks of cardiovascular disease. Am Heart J. 2005 Dec;150(6):1115-21. doi: 10.1016/j.ahj.2005.02.007.
- Background: PubMed 10463067Dixon L, Postrado L, Delahanty J, Fischer PJ, Lehman A. The association of medical comorbidity in schizophrenia with poor physical and mental health. J Nerv Ment Dis. 1999 Aug;187(8):496-502. doi: 10.1097/00005053-199908000-00006.
- Background: PubMed 11284901Davidson S, Judd F, Jolley D, Hocking B, Thompson S, Hyland B. Cardiovascular risk factors for people with mental illness. Aust N Z J Psychiatry. 2001 Apr;35(2):196-202. doi: 10.1046/j.1440-1614.2001.00877.x.
- Background: PubMed 11386985Druss BG, Bradford WD, Rosenheck RA, Radford MJ, Krumholz HM. Quality of medical care and excess mortality in older patients with mental disorders. Arch Gen Psychiatry. 2001 Jun;58(6):565-72. doi: 10.1001/archpsyc.58.6.565.
- Background: PubMed 20827954Trangle M, Gary M, Paul G, Christensen R. Minnesota 10 by 10. Reducing morbidity and mortality in people with serious mental illnesses. Minn Med. 2010 Jun;93(6):38-41.
- Background: PubMed 16198088Goff DC, Sullivan LM, McEvoy JP, Meyer JM, Nasrallah HA, Daumit GL, Lamberti S, D'Agostino RB, Stroup TS, Davis S, Lieberman JA. A comparison of ten-year cardiac risk estimates in schizophrenia patients from the CATIE study and matched controls. Schizophr Res. 2005 Dec 1;80(1):45-53. doi: 10.1016/j.schres.2005.08.010. Epub 2005 Sep 28.
- Background: PubMed 16965186Newcomer JW. Medical risk in patients with bipolar disorder and schizophrenia. J Clin Psychiatry. 2006;67 Suppl 9:25-30; discussion 36-42.
- Individual participant dataSharing planned: No
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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.
Rebecca C Rossom, MD principal investigator
HealthPartners Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prioritized Clinical Decision Support in people with Chronic Disease and Mental Disorder, run by HealthPartners Institute at 3 sites in United States.
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 5 inclusion and 5 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 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 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?
Predicted Annual Rate of Change in 10 Year Risk of Fatal or Nonfatal Heart Attack or Stroke (time frame: Index to 12 months post index visit). 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 NCT02451670, which also lists 56 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 5 Nov 2019.