BronchiectasisPhase 2STRATUSNCT01255592
Evaluation of the Effect of AZD5069 in Patients With Bronchiectasis
A Phase 2 study testing AZD5069 in people with Bronchiectasis and Lung Disease, run by AstraZeneca at 15 sites in 3 countries.
Trial summary
The purpose of this study is to investigate the effect of AZD5069 in patients with bronchiectasis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bronchiectasis, Lung Disease, Respiratory Diseases
- What is being tested?
- AZD5069
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 15 sitesin 3 countries
- Study dates
- Feb 2011to Feb 2012
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male, or female of non-child bearing potential; ie, women who are permanently or surgically sterilised or post-menopausal.
- Aged 18 to 80 years inclusive at screening (Visit 1)
- Have a clinical diagnosis of idiopathic or post infective bronchiectasis as diagnosed with a historical high resolution computerised tomography (HRCT) or bronchogram
- Be sputum producers with a history of chronic expectoration on most days of most weeks of the year. Patients should have a history of spontaneously producing sputum on a daily basis and should be able to provide at least 2 of the 3 required baseline sputum samples with an average of 3 mL or more.
- Be on a stable treatment regimen, as judged by the investigator.
Who cannot join
- Any clinically significant disease or disorder
- Patients with other latent or chronic infections or at risk of infection within 90 days before Visit 2
- An acute exacerbation or acute respiratory infection (upper or lower) requiring oral steroids or antibiotics within 30 days prior to Visit 2
- An FEV1 of <30% of predicted normal at Visit 1
- Patients who have received live or live-attenuated vaccine in the 2 weeks prior to dosing (Visit 2)
- Concomitant diagnosis of significant pulmonary disease other than bronchiectasis or COPD, including symptomatic asthma and allergic bronchopulmonary aspergillosis
- Bronchiectasis associated with a generalised immunodeficiency disorder, where manifestations other than bronchiectasis predominate
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
United Kingdom10 sites
Research Site
Belfast
Research Site
Birmingham, Wstmid
Research Site
Bristol
Research Site
Cambridge
Research Site
Hull, East Yorkshire
Research Site
Leicester, Leicestershire
Research Site
London
Research Site
Newcastle upon Tyne
Research Site
Salford
Research Site
Wolverhampton
About this study
Official title: A Phase II Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28-Day Oral Administration of AZD5069 Twice Daily in Patients With Bronchiectasis
The purpose of this study is to investigate the effect of AZD5069 in patients with bronchiectasis.
- Conditions
- Bronchiectasis, Lung Disease, Respiratory Diseases
- Being tested
- AZD5069, Placebo
- Keywords
- Bronchiectasis, Neutrophil, Respiratory disease, Sputum
- Medical subject headings
- Bronchiectasis, Lung Diseases, Respiratory Tract Diseases, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5069Drug
Oral dose bid
PlaceboDrug
Oral dose bid
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Treatment arm AZD5069 Receives: Drug: AZD5069 |
| 2 | Placebo comparator | Placebo dose. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of Absolute Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Measured: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Secondary outcomes (25)
Ratio of the Percentage Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Measured: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Change From Baseline in Weight of 24-hour Sputum Collection
Patients collected all sputum produced during a 24-hour period at baseline and Day 28.
Measured: Baseline and end of treatment (Day 28)
Change From Baseline in Slow Vital Capacity (SVC)
Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. SVC is the measure of the change in volume of gas in the lungs from complete inspiration to complete expiration.
Measured: Baseline to end of treatment (Day 28)
Change From Baseline in Forced Vital Capacity (FVC)
Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FVC is the maximum volume of air which can be exhaled or inspired during a forced maneuver.
Measured: Baseline to end of treatment (Day 28)
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEV1 is the volume expired in the first second of maximal expiration after a full inspiration.
Measured: Baseline to end of treatment (Day 28)
Change From Baseline in Forced Expiratory Flow Between 25% and 75% of Forced Vital Capacity (FEF25-75)
Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEF25-75 is flow rate during the middle half of forced vital capacity (25%-75% of the total volume (FVC) exhaled).
Measured: Baseline to end of treatment (Day 28)
Transition Dyspnea Index (TDI) at End of Treatment (Day 28)
TDI measures changes in dyspnea severity from the baseline as established by the Baseline Dyspnea Index (BDI). TDI is an interviewer-administered rating of severity of dyspnea that assesses Change in Functional Impairment, Change in Magnitude of Task, and Change in Magnitude of Effort domains on a 7-point scale ranging from -3 (major deterioration) to +3 (major improvement). Total score ranges from -9 to +9. The lower the score, the more deterioration in severity of dyspnea.
Measured: Baseline to end of treatment (Day 28)
Change From Baseline for the Morning PEF and Evening PEF of the Bronkotest Diary Card
The Bronkotest diary card is a paper based diary card that was filled out by patients daily, recording values from morning and evening peak expiratory flow (PEF) measurements and answering 8 questions on signs and symptoms. Summary statistics for baseline (mean of the last 7 days prior to first dose) and change (mean of the last 7 days on treatment - baseline) only contain patients included in the analysis. For symptom scores a decrease is an improvement, for PEF an increase is an improvement.
Measured: Baseline and Last 7 days on treatment
Change From Baseline for the Symptom Scores of the Bronkotest Diary Card
The Bronkotest diary card is a paper based diary card that was filled out by patients daily, recording values from morning and evening peak expiratory flow (PEF) measurements and answering 8 questions on signs and symptoms. Symptom scores were recorded for night-time symptoms, breathing, sputum colour, sputum amount, sputum type, wellbeing, number of puffs of inhalers, and cough, generally scored on a scale from 0 (no symptoms) to 4 (worst symptoms). Summary statistics for baseline (mean of the last 7 days prior to first dose) and change (mean of the last 7 days on treatment - baseline) only contain patients included in the analysis. For symptom scores a decrease is an improvement, for PEF an increase is an improvement.
Measured: Baseline and Last 7 days on treatment
Change From Baseline Total and Domain Scores in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C)
SGRQ-C total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). The SGRQ-C contains 3 domains:
Symptom (distress due to respiratory symptoms), Activity (disturbance of physical activity) and Impact (overall impact on daily life and well being). All three domains with scale from 0 (best health status) to 100 (worst possible status).
Measured: Baseline and end of treatment (Day 28)
Ratio of Interleukin-1 Beta (IL-1β) in Sputum at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Measured: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of Interleukin-6 (IL-6) in Sputum at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Measured: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) in Sputum at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Measured: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of Monocyte Chemoattractant Protein-1 (MCP-1) in Sputum at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Measured: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of Tumor Necrosis Factor Alpha (TNF-α) in Sputum at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Measured: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of Growth-related Oncogene-α (GRO-α) in Sputum at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Measured: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of Interleukin-8 (IL-8) in Sputum at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Measured: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of Neutrophil Elastase Activity in Sputum at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Measured: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of Serum Amyloid A (SAA) in Serum at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Measured: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of C-reactive Protein (CRP) in Serum at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Measured: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of Tumor Necrosis Factor Alpha (TNF-α) in Serum at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Measured: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of Growth-related Oncogene-α (GRO-α) in Serum at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Measured: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of Interleukin-6 (IL-6) in Serum at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Measured: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of Interleukin-1 Beta (IL-1β) in Serum at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Measured: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of Interleukin-8 (IL-8) in Serum at End of Treatment Compared to Baseline
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
Measured: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startFeb 2011
- Primary completionFeb 2012
- Study completionFeb 2012
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 BronchiectasisStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bengt Larsson,, M.B, Study director, AstraZeneca R&D Mölndal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255592
- Sponsor's protocol ID
- D3550C00014
- Acronym
- STRATUS
- Status last verified
- Sep 2015
- First submitted
- 2 Dec 2010
- Last updated
- 8 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28-Day Oral Administration of AZD5069 Twice Daily in Patients With Bronchiectasis
- ClinicalTrials.gov ID
- NCT01255592
- Acronym / sponsor ID
- STRATUS / D3550C00014
- Conditions
- Bronchiectasis, Lung Disease, Respiratory Diseases
- Keywords
- Bronchiectasis, Neutrophil, Respiratory disease, Sputum
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 7 Dec 2010 (estimated)
- Results
- Posted 8 Oct 2015
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 is to investigate the effect of AZD5069 in patients with bronchiectasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD5069Treatment arm AZD5069 |
| 2 | Placebo comparator | Drug: PlaceboPlacebo dose. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male, or female of non-child bearing potential; ie, women who are permanently or surgically sterilised or post-menopausal.
- Aged 18 to 80 years inclusive at screening (Visit 1)
- Have a clinical diagnosis of idiopathic or post infective bronchiectasis as diagnosed with a historical high resolution computerised tomography (HRCT) or bronchogram
- Be sputum producers with a history of chronic expectoration on most days of most weeks of the year. Patients should have a history of spontaneously producing sputum on a daily basis and should be able to provide at least 2 of the 3 required baseline sputum samples with an average of 3 mL or more.
- Be on a stable treatment regimen, as judged by the investigator.
Key exclusion criteria (7 listed)
- Any clinically significant disease or disorder
- Patients with other latent or chronic infections or at risk of infection within 90 days before Visit 2
- An acute exacerbation or acute respiratory infection (upper or lower) requiring oral steroids or antibiotics within 30 days prior to Visit 2
- An FEV1 of <30% of predicted normal at Visit 1
- Patients who have received live or live-attenuated vaccine in the 2 weeks prior to dosing (Visit 2)
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 |
|---|---|---|
| AZD5069Oral dose bid | Drug | 1 |
| PlaceboOral dose bid | Drug | 2 |
Primary outcome
Ratio of Absolute Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
25 secondary outcomes
Ratio of the Percentage Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Change From Baseline in Weight of 24-hour Sputum Collection
Time frame: Baseline and end of treatment (Day 28)
Change From Baseline in Slow Vital Capacity (SVC)
Time frame: Baseline to end of treatment (Day 28)
Change From Baseline in Forced Vital Capacity (FVC)
Time frame: Baseline to end of treatment (Day 28)
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline to end of treatment (Day 28)
Change From Baseline in Forced Expiratory Flow Between 25% and 75% of Forced Vital Capacity (FEF25-75)
Time frame: Baseline to end of treatment (Day 28)
Transition Dyspnea Index (TDI) at End of Treatment (Day 28)
Time frame: Baseline to end of treatment (Day 28)
Change From Baseline for the Morning PEF and Evening PEF of the Bronkotest Diary Card
Time frame: Baseline and Last 7 days on treatment
Change From Baseline for the Symptom Scores of the Bronkotest Diary Card
Time frame: Baseline and Last 7 days on treatment
Change From Baseline Total and Domain Scores in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C)
Time frame: Baseline and end of treatment (Day 28)
Ratio of Interleukin-1 Beta (IL-1β) in Sputum at End of Treatment Compared to Baseline
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of Interleukin-6 (IL-6) in Sputum at End of Treatment Compared to Baseline
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) in Sputum at End of Treatment Compared to Baseline
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of Monocyte Chemoattractant Protein-1 (MCP-1) in Sputum at End of Treatment Compared to Baseline
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of Tumor Necrosis Factor Alpha (TNF-α) in Sputum at End of Treatment Compared to Baseline
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of Growth-related Oncogene-α (GRO-α) in Sputum at End of Treatment Compared to Baseline
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of Interleukin-8 (IL-8) in Sputum at End of Treatment Compared to Baseline
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of Neutrophil Elastase Activity in Sputum at End of Treatment Compared to Baseline
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of Serum Amyloid A (SAA) in Serum at End of Treatment Compared to Baseline
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of C-reactive Protein (CRP) in Serum at End of Treatment Compared to Baseline
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of Tumor Necrosis Factor Alpha (TNF-α) in Serum at End of Treatment Compared to Baseline
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of Growth-related Oncogene-α (GRO-α) in Serum at End of Treatment Compared to Baseline
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of Interleukin-6 (IL-6) in Serum at End of Treatment Compared to Baseline
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of Interleukin-1 Beta (IL-1β) in Serum at End of Treatment Compared to Baseline
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of Interleukin-8 (IL-8) in Serum at End of Treatment Compared to Baseline
Time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- CSR SynopsisLink provided by the sponsor.
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Bronchiectasis
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.
Bengt Larsson,, M.B study director
AstraZeneca R&D Mölndal
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD5069 in people with Bronchiectasis and Lung Disease, run by AstraZeneca at 15 sites in 3 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 5 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: finished, as of the sponsor's last update on 8 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United Kingdom, Poland, Czechia. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 8 Oct 2015). 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?
Ratio of Absolute Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline (time frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.). 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 8 Oct 2015.