HealthyASI-2012NCT01722474
Assessment of Three Instruments for the Non-invasive Measurement of Arterial Stiffness.
A study testing ASI Device in people with Healthy and Diabetes Type 2, run by University of Manitoba at 1 site in Canada.
Trial summary
The ASI Non-Invasive Arterial Stiffness Screening Device (ASI Device) is an investigational device under development for the non-invasive assessment of arterial stiffness. The ASI Device is considerably smaller and more cost effective than its commercially available counterparts. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Diabetes Type 2, Obesity
- What is being tested?
- ASI Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2012to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants of the Healthy Group must meet the following criteria to be eligible for participation in the study:
- Healthy male or female, greater or equal to 20 and less than or equal to 70 years of age;
- Willing to comply with the protocol requirements;
- Willing to provide informed consent.
- Participants of the Obese/Type 2 Diabetes Group must meet the following criteria to be eligible for participation in the study:
- Male or female, greater or equal to 20 and less than or equal to 70 years of age;
Show all 18Show fewer
- Presence of clinically diagnosed Type 2 Diabetes, and/or a body mass index (BMI) > 30;
- Willing to comply with the protocol requirements;
- Willing to provide informed consent.
- Participants of the Vascular Disease Group must meet the following criteria to be eligible for participation in the study:
- Male or female, greater or equal to 20 and less than or equal to 70 years of age;
- Documented evidence of atherosclerosis as manifested by one of the following:
- documented myocardial infarction;
- documented CAD as defined as >70% stenosis of an epicardial coronary artery;
- documented PAD including those with claudication as defined by an ankle brachial index of <0.9;
- angiographically documented carotid or lower limb stenosis of >50%
- Willing to comply with the protocol requirements;
- Willing to provide informed consent -
Who cannot join
- Participants of the Healthy Group will be excluded if they have any of the following:
- Presence of a clinically diagnosed disease affecting the circulatory, respiratory, immune, skeletal, urinary, muscular, endocrine, digestive, nervous or reproductive system that requires medical treatment;
- Cigarette/cigar smoking, current or within the last 6 months;
- Current (within the last 30 days) bacterial, viral or fungal infection;
- Taking any prescribed medication (with the exception of birth control or HRT) within the last 3 months or over-the-counter medication within the past 72 h;
- Pregnancy;
Show all 26Show fewer
- Amputation or malformation of any limb or extremity (fingers, leg, or arm) which would impede the placement of sensors, probes, or blood pressure cuffs.
- Participants of the Obese/Type 2 Diabetes Group will be excluded if they have any of the following:
- Documented evidence of atherosclerosis as manifested by one of the following:
- documented myocardial infarction;
- documented CAD as defined as >70% stenosis of an epicardial coronary artery;
- documented PAD including those with claudication as defined by an ankle brachial index of <0.9;
- angiographically documented carotid or lower limb stenosis of >50%
- having had a documented previous intervention for CAD or PAD.
- Cigarette/cigar smoking, current or within the last 6 months;
- Current (within the last 30 days) bacterial, viral or fungal infection;
- Taking over-the-counter medication within the past 72 h;
- Pregnancy;
- Amputation or malformation of any limb or extremity (fingers, leg, or arm) which would impede the placement of sensors, probes, or blood pressure cuffs.
- Participants of the Vascular Disease Group will be excluded if they have any of the following:
- Cigarette/cigar smoking, current or within the last 6 months;
- Current (within the last 30 days) bacterial, viral or fungal infection;
- Taking over-the-counter medication within the past 72 h;
- Pregnancy;
- Amputation or malformation of any limb or extremity (fingers, leg, or arm) which would impede the placement of sensors, probes, or blood pressure cuffs.
- Having had a documented previous intervention for CAD or PAD
Trial locations and contacts
1 site in 1 country.
Canada1 site
St. Boniface General Hospital - Asper Clinical Research Institute
Winnipeg, Manitoba, R2H 2A6
About this study
The ASI Non-Invasive Arterial Stiffness Screening Device (ASI Device) is an investigational device under development for the non-invasive assessment of arterial stiffness. The ASI Device is considerably smaller and more cost effective than its commercially available counterparts. As the device is readily portable, it is intended to be targeted for use in the community (or at home), as opposed to within the hospital or clinic setting only. However, as the device is still under development, it is not known whether it is capable of determining arterial stiffness with the same sensitivity and consistency as those already in commercial use. An added variable is the fact the sensor for the ASI Device is located on the fingertip.
Validation is a prerequisite for obtaining Health Canada approval of devices for diagnostic purposes. The ASI Device has not been tested against other instruments capable of providing similar measurements. Therefore, a clinical trial to compare the ASI Device against similar devices is necessary. The study will compare measurements of arterial stiffness and other central haemodynamic parameters obtained with the ASI Device against similar measurements from devices that have already been approved for this purpose by Health Canada/United States Food and Drug Administration (FDA).
Read the detailed description
This is an exploratory, proof of concept, open sequential registration comparative study designed to establish the utility and accuracy of the ASI Non-Invasive Arterial Stiffness Screening Device (ASI-Device) for the non-invasive vascular assessment of arterial stiffness relative to other such devices already approved and commercially available in Canada and the United States.
The pressure exerted from the contraction of the heart creates a wave form, which travels down the individual's arterial trunk to all parts of the body. The velocity (speed) at which this wave form travels can serve as an indicator of the degree of arterial stiffness. The faster the speed of travel of the pulse wave the stiffer the arteries. It has been demonstrated in other studies that the contour (shape) of the waveform can be affected by the pulse wave velocity and that analysis of this shape is an acceptable surrogate for determining the pulse wave velocity and ultimately determining the severity of arterial stiffness. This method of analysing the contour of the pulse wave to determine the severity of arterial stiffness is called pulse wave analysis (PWA).
The ASI Device non-invasively measures the severity of arterial stiffness derived through pulse wave analysis. The study will compare measurements of arterial stiffness and other central haemodynamic parameters, as derived through pulse wave analysis obtained with the ASI Device, against similar measurements from the SphygmoCor Px System from AtCor and the CR-2000 CV Profiler from Hypertension Inc, devices that already have approval for this purpose by Health Canada and/or the United States Food and Drug Administration.
Three groups of individuals will be sought;
- Healthy participants (n=25)
- Persons with Type 2 Diabetes and/or Obesity (n=15)
- Persons with a diagnosed Cardiovascular/Vascular disease (such as CAD or PAD) (n=15)
Participants will be asked to provide written informed consent prior to participation in the study. Eligible participants will be asked to attend an in-person visit where they will undergo the non-invasive vascular testing. Testing will be comprised of:
- Pulse Wave Analysis using the ASI Device
- Pulse Wave Analysis using the SphygmoCor Device
- Pulse Wave Analysis using the CR-2000 CV Profiler
Although pulse wave contour analysis (PWA) has been demonstrated to be an acceptable surrogate for the assessment of arterial stiffness, Pulse Wave Velocity has been the gold standard for the assessment of arterial stiffness. As such, the VP-1000, a non-invasive vascular screening device, will also be used to measure pulse wave velocity.
- Being tested
- ASI Device
- Keywords
- Pulse Wave Analysis, Arterial Stiffness
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Coronary Artery Disease, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASI DeviceDevice
Also called ASI Non-Invasive Arterial Stiffness Screening Device
| Study group | Role | What they receive |
|---|---|---|
| ASI Device | Experimental | Study Participants will attend the research clinic one time (one visit) for the vascular testing. Each instrument/assessment will be run sequentially starting with the Arterial Stiffness Screening Device, then followed by SphygmoCor system, which will then be followed by the CR-2000 CV Profiler, then finally the VP-1000. Receives: Device: ASI Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the ability of the non-invasive ASI Device to determine arterial stiffness as compared to SphygmoCor, CR-2000 CV Profiler and VP-1000.
The average, median, and standard deviation of outcomes from PWA (i.e. augmentation index, or equivalent stiffness index), will be calculated and a correlation analysis conducted to compare the results obtained from each instrument.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionJul 2013
- Study completionSep 2013
Why it stopped: Minor device modifications required, move revised device to clinical site in USA.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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 N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- St. Boniface Hospital, Arterial Stiffness Incorporated
- Responsible party
- Principal investigator, Dr. Peter Zahradka, University of Manitoba
- Investigators
- Peter C Zahradka, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01722474
- Sponsor's protocol ID
- B2012:040
- Acronym
- ASI-2012
- Status last verified
- Feb 2014
- First submitted
- 2 Nov 2012
- Last updated
- 12 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
O'Rourke MF, Staessen JA, Vlachopoulos C, Duprez D, Plante GE. Clinical applications of arterial stiffness; definitions and reference values. Am J Hypertens. 2002 May;15(5):426-44. doi: 10.1016/s0895-7061(01)02319-6.
PubMed 12022246Laurent S, Cockcroft J, Van Bortel L, Boutouyrie P, Giannattasio C, Hayoz D, Pannier B, Vlachopoulos C, Wilkinson I, Struijker-Boudier H; European Network for Non-invasive Investigation of Large Arteries. Expert consensus document on arterial stiffness: methodological issues and clinical applications. Eur Heart J. 2006 Nov;27(21):2588-605. doi: 10.1093/eurheartj/ehl254. Epub 2006 Sep 25.
PubMed 17000623Weatherley BD, Nelson JJ, Heiss G, Chambless LE, Sharrett AR, Nieto FJ, Folsom AR, Rosamond WD. The association of the ankle-brachial index with incident coronary heart disease: the Atherosclerosis Risk In Communities (ARIC) study, 1987-2001. BMC Cardiovasc Disord. 2007 Jan 16;7:3. doi: 10.1186/1471-2261-7-3.
PubMed 17227586Ding FH, Fan WX, Zhang RY, Zhang Q, Li Y, Wang JG. Validation of the noninvasive assessment of central blood pressure by the SphygmoCor and Omron devices against the invasive catheter measurement. Am J Hypertens. 2011 Dec;24(12):1306-11. doi: 10.1038/ajh.2011.145. Epub 2011 Oct 6.
PubMed 21976274Wilkinson IB, Fuchs SA, Jansen IM, Spratt JC, Murray GD, Cockcroft JR, Webb DJ. Reproducibility of pulse wave velocity and augmentation index measured by pulse wave analysis. J Hypertens. 1998 Dec;16(12 Pt 2):2079-84. doi: 10.1097/00004872-199816121-00033.
PubMed 9886900Siebenhofer A, Kemp C, Sutton A, Williams B. The reproducibility of central aortic blood pressure measurements in healthy subjects using applanation tonometry and sphygmocardiography. J Hum Hypertens. 1999 Sep;13(9):625-9. doi: 10.1038/sj.jhh.1000887.
PubMed 10482972Dhindsa M, Sommerlad SM, DeVan AE, Barnes JN, Sugawara J, Ley O, Tanaka H. Interrelationships among noninvasive measures of postischemic macro- and microvascular reactivity. J Appl Physiol (1985). 2008 Aug;105(2):427-32. doi: 10.1152/japplphysiol.90431.2008. Epub 2008 May 15.
PubMed 18483158
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Three Instruments for the Non-invasive Measurement of Arterial Stiffness.
- ClinicalTrials.gov ID
- NCT01722474
- Acronym / sponsor ID
- ASI-2012 / B2012:040
- Keywords
- Pulse Wave Analysis, Arterial Stiffness
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Minor device modifications required, move revised device to clinical site in USA.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- St. Boniface Hospital, Arterial Stiffness Incorporated
- Study start
- Oct 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 6 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ASI Non-Invasive Arterial Stiffness Screening Device (ASI Device) is an investigational device under development for the non-invasive assessment of arterial stiffness. The ASI Device is considerably smaller and more cost effective than its commercially available counterparts. As the device is readily portable, it is intended to be targeted for use in the community (or at home), as opposed to within the hospital or clinic setting only. However, as the device is still under development, it is not known whether it is capable of determining arterial stiffness with the same sensitivity and consistency as those already in commercial use. An added variable is the fact the sensor for the ASI Device is located on the fingertip.
Validation is a prerequisite for obtaining Health Canada approval of devices for diagnostic purposes. The ASI Device has not been tested against other instruments capable of providing similar measurements. Therefore, a clinical trial to compare the ASI Device against similar devices is necessary. The study will compare measurements of arterial stiffness and other central haemodynamic parameters obtained with the ASI Device against similar measurements from devices that have already been approved for this purpose by Health Canada/United States Food and Drug Administration (FDA).
Detailed description
This is an exploratory, proof of concept, open sequential registration comparative study designed to establish the utility and accuracy of the ASI Non-Invasive Arterial Stiffness Screening Device (ASI-Device) for the non-invasive vascular assessment of arterial stiffness relative to other such devices already approved and commercially available in Canada and the United States.
The pressure exerted from the contraction of the heart creates a wave form, which travels down the individual's arterial trunk to all parts of the body. The velocity (speed) at which this wave form travels can serve as an indicator of the degree of arterial stiffness. The faster the speed of travel of the pulse wave the stiffer the arteries. It has been demonstrated in other studies that the contour (shape) of the waveform can be affected by the pulse wave velocity and that analysis of this shape is an acceptable surrogate for determining the pulse wave velocity and ultimately determining the severity of arterial stiffness. This method of analysing the contour of the pulse wave to determine the severity of arterial stiffness is called pulse wave analysis (PWA).
The ASI Device non-invasively measures the severity of arterial stiffness derived through pulse wave analysis. The study will compare measurements of arterial stiffness and other central haemodynamic parameters, as derived through pulse wave analysis obtained with the ASI Device, against similar measurements from the SphygmoCor Px System from AtCor and the CR-2000 CV Profiler from Hypertension Inc, devices that already have approval for this purpose by Health Canada and/or the United States Food and Drug Administration.
Three groups of individuals will be sought;
- Healthy participants (n=25)
- Persons with Type 2 Diabetes and/or Obesity (n=15)
- Persons with a diagnosed Cardiovascular/Vascular disease (such as CAD or PAD) (n=15)
Participants will be asked to provide written informed consent prior to participation in the study. Eligible participants will be asked to attend an in-person visit where they will undergo the non-invasive vascular testing. Testing will be comprised of:
- Pulse Wave Analysis using the ASI Device
- Pulse Wave Analysis using the SphygmoCor Device
- Pulse Wave Analysis using the CR-2000 CV Profiler
Although pulse wave contour analysis (PWA) has been demonstrated to be an acceptable surrogate for the assessment of arterial stiffness, Pulse Wave Velocity has been the gold standard for the assessment of arterial stiffness. As such, the VP-1000, a non-invasive vascular screening device, will also be used to measure pulse wave velocity.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASI Device | Experimental | Device: ASI DeviceStudy Participants will attend the research clinic one time (one visit) for the vascular testing. Each instrument/assessment will be run sequentially starting with the Arterial Stiffness Screening Device, then followed by SphygmoCor system, which will then be followed by the CR-2000 CV Profiler, then finally the VP-1000. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Participants of the Healthy Group must meet the following criteria to be eligible for participation in the study:
- Healthy male or female, greater or equal to 20 and less than or equal to 70 years of age;
- Willing to comply with the protocol requirements;
- Willing to provide informed consent.
- Participants of the Obese/Type 2 Diabetes Group must meet the following criteria to be eligible for participation in the study:
Key exclusion criteria (26 listed)
- Presence of a clinically diagnosed disease affecting the circulatory, respiratory, immune, skeletal, urinary, muscular, endocrine, digestive, nervous or reproductive system that requires medical treatment;
- Cigarette/cigar smoking, current or within the last 6 months;
- Current (within the last 30 days) bacterial, viral or fungal infection;
- Taking any prescribed medication (with the exception of birth control or HRT) within the last 3 months or over-the-counter medication within the past 72 h;
- Pregnancy;
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 |
|---|---|---|
| ASI DeviceAlso: ASI Non-Invasive Arterial Stiffness Screening Device | Device | ASI Device |
Primary outcome
To compare the ability of the non-invasive ASI Device to determine arterial stiffness as compared to SphygmoCor, CR-2000 CV Profiler and VP-1000.
Time frame: 1 day
The average, median, and standard deviation of outcomes from PWA (i.e. augmentation index, or equivalent stiffness index), will be calculated and a correlation analysis conducted to compare the results obtained from each instrument.
Results and safety
The study was stopped early (reason given: Minor device modifications required, move revised device to clinical site in USA.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2014.
- Background: PubMed 12022246O'Rourke MF, Staessen JA, Vlachopoulos C, Duprez D, Plante GE. Clinical applications of arterial stiffness; definitions and reference values. Am J Hypertens. 2002 May;15(5):426-44. doi: 10.1016/s0895-7061(01)02319-6.
- Background: PubMed 17000623Laurent S, Cockcroft J, Van Bortel L, Boutouyrie P, Giannattasio C, Hayoz D, Pannier B, Vlachopoulos C, Wilkinson I, Struijker-Boudier H; European Network for Non-invasive Investigation of Large Arteries. Expert consensus document on arterial stiffness: methodological issues and clinical applications. Eur Heart J. 2006 Nov;27(21):2588-605. doi: 10.1093/eurheartj/ehl254. Epub 2006 Sep 25.
- Results publication: PubMed 17227586Weatherley BD, Nelson JJ, Heiss G, Chambless LE, Sharrett AR, Nieto FJ, Folsom AR, Rosamond WD. The association of the ankle-brachial index with incident coronary heart disease: the Atherosclerosis Risk In Communities (ARIC) study, 1987-2001. BMC Cardiovasc Disord. 2007 Jan 16;7:3. doi: 10.1186/1471-2261-7-3.
- Results publication: PubMed 21976274Ding FH, Fan WX, Zhang RY, Zhang Q, Li Y, Wang JG. Validation of the noninvasive assessment of central blood pressure by the SphygmoCor and Omron devices against the invasive catheter measurement. Am J Hypertens. 2011 Dec;24(12):1306-11. doi: 10.1038/ajh.2011.145. Epub 2011 Oct 6.
- Results publication: PubMed 9886900Wilkinson IB, Fuchs SA, Jansen IM, Spratt JC, Murray GD, Cockcroft JR, Webb DJ. Reproducibility of pulse wave velocity and augmentation index measured by pulse wave analysis. J Hypertens. 1998 Dec;16(12 Pt 2):2079-84. doi: 10.1097/00004872-199816121-00033.
- Results publication: PubMed 10482972Siebenhofer A, Kemp C, Sutton A, Williams B. The reproducibility of central aortic blood pressure measurements in healthy subjects using applanation tonometry and sphygmocardiography. J Hum Hypertens. 1999 Sep;13(9):625-9. doi: 10.1038/sj.jhh.1000887.
- Results publication: PubMed 18483158Dhindsa M, Sommerlad SM, DeVan AE, Barnes JN, Sugawara J, Ley O, Tanaka H. Interrelationships among noninvasive measures of postischemic macro- and microvascular reactivity. J Appl Physiol (1985). 2008 Aug;105(2):427-32. doi: 10.1152/japplphysiol.90431.2008. Epub 2008 May 15.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Peter C Zahradka, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASI Device in people with Healthy and Diabetes Type 2, run by University of Manitoba at 1 site in Canada.
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 18 inclusion and 26 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 12 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
The study was stopped early (reason given: Minor device modifications required, move revised device to clinical site in USA.). Results are not available in the source record.
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?
To compare the ability of the non-invasive ASI Device to determine arterial stiffness as compared to SphygmoCor, CR-2000 CV Profiler and VP-1000. (time frame: 1 day). 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 NCT01722474, which also lists 7 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 12 Feb 2014.