Smoking CessationPhase 2NCT03709823

Trial of Cytisine in Adult Smokers

A Phase 2 study testing Cytisine and Behavioral support in people with Smoking Cessation, run by Achieve Life Sciences at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This placebo-controlled Phase 2b trial is being conducted at sites within the United States (US) to evaluate the effectiveness cytisine dosage (1.5 mg, 3.0 mg) and administration schedule (commercial titration versus simplified 3 times daily [TID] schedule) within a 25-day treatment period. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Smoking Cessation
What is being tested?: Cytisine and Behavioral support
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 254 participants
Where: 8 sitesUnited States
Study dates: 13 Nov 2018to 23 Apr 2019
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female subjects, age ≥ 18 years.
Current daily cigarette smokers (averaging ≥ 10 cigarettes per day upon completing a 7-day screening diary) and who intend to quit smoking.
Expired air carbon monoxide (CO) ≥ 10 parts per million (ppm).
Failed at least one previous attempt to stop smoking with or without therapeutic support.
Willing to initiate study treatment on the day after randomization and set a quit date that is 5-7 days after starting treatment.
Willing to actively participate in the study's smoking cessation behavioral support provided throughout the study.
Able to fully understand all study requirements, willing to participate, comply with dosing schedule, and sign the Informed Consent Form.

Who cannot join

Known hypersensitivity to cytisine or any of the excipients.
Positive urinary drugs of abuse screen, determined within 28 days before the first dose of cytisine.
Clinically significant abnormal serum chemistry or hematology values within 28 days of randomization (i.e. requiring treatment).
Clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined after minimum of 5 minutes in supine position within 28 days of randomization (i.e. requiring treatment or further assessment).
Body mass index (BMI) classification for being underweight (< 18.5 kg/m^2) or having ≥ Class 2 obesity (≥ 35 kg/m^2).
Recent history (within 3 months) of acute myocardial infarction, unstable angina, stroke, cerebrovascular incident or hospitalization for congestive heart failure.

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Current uncontrolled hypertension (blood pressure ≥ 160/100 mmHg).
Documented diagnosis of schizophrenia or bipolar psychiatric illness; currently psychotic; having suicidal ideation (Suicide Behaviors Questionnaire-Revised [SBQ-R] score ≥ 7); or current symptoms of moderate to severe depression (Hospital Anxiety and Depression Scale [HADS] score ≥ 11).
Renal impairment defined as a creatinine clearance (CrCl) < 60 mL/min (estimated with the Cockroft-Gault equation) or hepatic impairment defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.0 times the upper limit of normal (ULN).
Women who are pregnant or breast-feeding.
Male or Female subjects of child bearing potential who do not agree to use acceptable methods of birth control during the study treatment period.
Participation in a clinical study with an investigational drug within 4 weeks of randomization.
Treatment with other smoking cessation medications (bupropion, varenicline, nortriptyline, or any nicotine replacement therapy [NRT]) within 4 weeks of randomization or planned use of these other smoking cessation medications during the study.
Use within 2 weeks of randomization or planned use during the study of non-cigarette nicotine products (e-cigarettes, pipe tobacco, cigars, snuff, chewing tobacco, hookah) or marijuana vaping or smoking.
Any other reason that the investigator views the subject should not participate or would be unable to fulfill the requirements for the study.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Los Angeles Clinical Trials
Burbank, California, 91505
FutureSearch Trails of Dallas, LP
Dallas, Texas, 57231
Center for Pharmaceutical Research, LLC
Kansas City, Missouri, 64114
Volunteer Research Group
Knoxville, Tennessee, 37920
Central Kentucky Research Associates, LLC
Lexington, Kentucky, 40509
Coastal Carolina Research Center, Inc
Mt. Pleasant, South Carolina, 29464
Rochester Clinical Research, Inc
Rochester, New York, 14609
Clinical Research Consortium
Tempe, Arizona, 85283

Other trials in United States

About this study

Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 2b Trial of Cytisine in Adult Smokers

Conditions: Smoking Cessation
Being tested: Cytisine, Placebo Comparator, Behavioral support
Medical subject headings: Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CytisineDrug
film coated tablet containing 1.5 mg cytisine in a single tablet
Placebo ComparatorDrug
1.5 mg cellulose powder to match final weight of the cytisine tablet
Behavioral supportBehavioural
12 behavioral support sessions by a qualified staff member plus supportive literature and online resources

Study groups in NCT03709823
Study group	Role	What they receive
1.5 mg Cytisine, Commercial Schedule	Experimental	1.5 mg cytisine dose using the commercial 25-day titration schedule + behavioral support Receives: Drug: Cytisine; Behavioral: Behavioral support
3.0 mg Cytisine, Commercial Schedule	Experimental	3.0 mg cytisine dose using the commercial 25-day titration schedule + behavioral support Receives: Drug: Cytisine; Behavioral: Behavioral support
Placebo, Commercial Schedule	Placebo comparator	Placebo tablets using the commercial 25-day titration schedule + behavioral support Receives: Drug: Placebo Comparator; Behavioral: Behavioral support
1.5 mg Cytisine, TID Schedule	Experimental	1.5 mg cytisine dose for 25 days using a simplified 3 times daily (TID) schedule + behavioral support Receives: Drug: Cytisine; Behavioral: Behavioral support
3.0 mg Cytisine, TID Schedule	Experimental	3.0 mg cytisine dose for 25 days using a simplified TID schedule + behavioral support Receives: Drug: Cytisine; Behavioral: Behavioral support
Placebo, TID Schedule	Placebo comparator	Placebo tablets for 25 days using a simplified TID schedule + behavioral support Receives: Drug: Placebo Comparator; Behavioral: Behavioral support

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary Efficacy Analysis of Primary Outcome Measure: Percentage of Expected Cigarettes Smoked Per Participant During Study Treatment
The daily cigarette counts (number of cigarettes smoked in the past 24 hours) were self-reported by participants in the diary. Percentage of expected cigarettes smoked was computed for each participant at the end of treatment (cigarette score), based on daily cigarette counts during treatment vs the screening period. The percentage of expected cigarettes smoked was computed as Y = (100 x N) / (T x R) where N represents total number of cigarettes smoked each day over the treatment period from Day 1 to Day 25; T represents number of post-randomization days where number of cigarettes smoked is recorded; and R represents the average number of cigarettes smoked daily over the 7-day screening period as baseline. T*R represents the total number of cigarettes that would have been smoked without intervention over the number of recorded days. Separate statistical analyses were performed for the two cytisine administration schedules (commercial and TID).
Measured: Day 1 through Day 25
Sensitivity Analysis of Primary Outcome Measure: Analysis for Percentage of Expected Cigarettes Smoked Versus Pooled Placebo Arms, Commercial Schedule
The daily cigarette counts (number of cigarettes smoked in the past 24 hours) were self-reported by participants in the diary. Percentage of expected cigarettes smoked was computed for each participant at the end of treatment (cigarette score), based on daily cigarette counts during treatment vs the screening period. (See Outcome Measure 1 description for details.) The sensitivity analysis of the primary outcome measure was only performed if results of "Statistical Analysis 5" for Outcome Measure 1 demonstrated the placebo treatment arms (commercial and TID) were not significantly different, and so could be pooled. Separate statistical analyses were performed for the two cytisine administration schedules (commercial and TID).
Measured: Day 1 through Day 25
Sensitivity Analysis of Primary Outcome Measure: Analysis for Percentage of Expected Cigarettes Smoked Versus Pooled Placebo Arms, TID Schedule
The daily cigarette counts (number of cigarettes smoked in the past 24 hours) were self-reported by participants in the diary. Percentage of expected cigarettes smoked was computed for each participant at the end of treatment (cigarette score), based on daily cigarette counts during treatment vs the screening period. (See Outcome Measure 1 description for details.) The sensitivity analysis of the primary outcome measure was only performed if results of "Statistical Analysis 5" for Outcome Measure 1 demonstrated the placebo treatment arms (commercial and TID) were not significantly different, and so could be pooled. Separate statistical analyses were performed for the two cytisine administration schedules (commercial and TID).
Measured: Day 1 through Day 25

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Nov 201823 Apr 2019

First posted17 Oct 2018
Study start13 Nov 2018
Primary completion23 Apr 2019
Study completion23 Apr 2019

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 Smoking CessationStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 254 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03709823
Sponsor's protocol ID: ACH-CYT-09
Status last verified: May 2020
First submitted: 15 Oct 2018
Last updated: 18 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Smoking Cessation trials

Study at a glance

From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 2b Trial of Cytisine in Adult Smokers
ClinicalTrials.gov ID: NCT03709823
Acronym / sponsor ID: ACH-CYT-09
Conditions: Smoking Cessation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 254 participants (actual)
Lead sponsor: Achieve Life SciencesIndustry (pharma, biotech, devices)
Study start: 13 Nov 2018 (actual)
Primary completion: 23 Apr 2019 (actual)
Study completion: 23 Apr 2019 (actual)
First posted: 17 Oct 2018 (actual)
Results: Posted 18 May 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
1.5 mg Cytisine, Commercial Schedule	Experimental	Drug: Cytisine, Behavioral: Behavioral support1.5 mg cytisine dose using the commercial 25-day titration schedule + behavioral support
3.0 mg Cytisine, Commercial Schedule	Experimental	Drug: Cytisine, Behavioral: Behavioral support3.0 mg cytisine dose using the commercial 25-day titration schedule + behavioral support
Placebo, Commercial Schedule	Placebo comparator	Drug: Placebo Comparator, Behavioral: Behavioral supportPlacebo tablets using the commercial 25-day titration schedule + behavioral support
1.5 mg Cytisine, TID Schedule	Experimental	Drug: Cytisine, Behavioral: Behavioral support1.5 mg cytisine dose for 25 days using a simplified 3 times daily (TID) schedule + behavioral support
3.0 mg Cytisine, TID Schedule	Experimental	Drug: Cytisine, Behavioral: Behavioral support3.0 mg cytisine dose for 25 days using a simplified TID schedule + behavioral support
Placebo, TID Schedule	Placebo comparator	Drug: Placebo Comparator, Behavioral: Behavioral supportPlacebo tablets for 25 days using a simplified TID schedule + behavioral support

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Male or female subjects, age ≥ 18 years.
Current daily cigarette smokers (averaging ≥ 10 cigarettes per day upon completing a 7-day screening diary) and who intend to quit smoking.
Expired air carbon monoxide (CO) ≥ 10 parts per million (ppm).
Failed at least one previous attempt to stop smoking with or without therapeutic support.
Willing to initiate study treatment on the day after randomization and set a quit date that is 5-7 days after starting treatment.

Key exclusion criteria (15 listed)

Known hypersensitivity to cytisine or any of the excipients.
Positive urinary drugs of abuse screen, determined within 28 days before the first dose of cytisine.
Clinically significant abnormal serum chemistry or hematology values within 28 days of randomization (i.e. requiring treatment).
Clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined after minimum of 5 minutes in supine position within 28 days of randomization (i.e. requiring treatment or further assessment).
Body mass index (BMI) classification for being underweight (< 18.5 kg/m^2) or having ≥ Class 2 obesity (≥ 35 kg/m^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
Cytisinefilm coated tablet containing 1.5 mg cytisine in a single tablet	Drug	1.5 mg Cytisine, Commercial Schedule, 1.5 mg Cytisine, TID Schedule, 3.0 mg Cytisine, Commercial Schedule, 3.0 mg Cytisine, TID Schedule
Placebo Comparator1.5 mg cellulose powder to match final weight of the cytisine tablet	Drug	Placebo, Commercial Schedule, Placebo, TID Schedule
Behavioral support12 behavioral support sessions by a qualified staff member plus supportive literature and online resources	Behavioural	1.5 mg Cytisine, Commercial Schedule, 1.5 mg Cytisine, TID Schedule, 3.0 mg Cytisine, Commercial Schedule, 3.0 mg Cytisine, TID Schedule, Placebo, Commercial Schedule, Placebo, TID Schedule

Primary outcome

Primary Efficacy Analysis of Primary Outcome Measure: Percentage of Expected Cigarettes Smoked Per Participant During Study Treatment
Time frame: Day 1 through Day 25
The daily cigarette counts (number of cigarettes smoked in the past 24 hours) were self-reported by participants in the diary. Percentage of expected cigarettes smoked was computed for each participant at the end of treatment (cigarette score), based on daily cigarette counts during treatment vs the screening period. The percentage of expected cigarettes smoked was computed as Y = (100 x N) / (T x R) where N represents total number of cigarettes smoked each day over the treatment period from Day 1 to Day 25; T represents number of post-randomization days where number of cigarettes smoked is recorded; and R represents the average number of cigarettes smoked daily over the 7-day screening period as baseline. T*R represents the total number of cigarettes that would have been smoked without intervention over the number of recorded days. Separate statistical analyses were performed for the two cytisine administration schedules (commercial and TID).
Sensitivity Analysis of Primary Outcome Measure: Analysis for Percentage of Expected Cigarettes Smoked Versus Pooled Placebo Arms, Commercial Schedule
Time frame: Day 1 through Day 25
The daily cigarette counts (number of cigarettes smoked in the past 24 hours) were self-reported by participants in the diary. Percentage of expected cigarettes smoked was computed for each participant at the end of treatment (cigarette score), based on daily cigarette counts during treatment vs the screening period. (See Outcome Measure 1 description for details.) The sensitivity analysis of the primary outcome measure was only performed if results of "Statistical Analysis 5" for Outcome Measure 1 demonstrated the placebo treatment arms (commercial and TID) were not significantly different, and so could be pooled. Separate statistical analyses were performed for the two cytisine administration schedules (commercial and TID).
Sensitivity Analysis of Primary Outcome Measure: Analysis for Percentage of Expected Cigarettes Smoked Versus Pooled Placebo Arms, TID Schedule
Time frame: Day 1 through Day 25
The daily cigarette counts (number of cigarettes smoked in the past 24 hours) were self-reported by participants in the diary. Percentage of expected cigarettes smoked was computed for each participant at the end of treatment (cigarette score), based on daily cigarette counts during treatment vs the screening period. (See Outcome Measure 1 description for details.) The sensitivity analysis of the primary outcome measure was only performed if results of "Statistical Analysis 5" for Outcome Measure 1 demonstrated the placebo treatment arms (commercial and TID) were not significantly different, and so could be pooled. Separate statistical analyses were performed for the two cytisine administration schedules (commercial and TID).

Results and safety

Results posted to the registry on 18 May 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1.5 mg Cytisine, Commercial Schedule	51	48
3.0 mg Cytisine, Commercial Schedule	50	45
Placebo, Commercial Schedule	25	22
1.5 mg Cytisine, TID Schedule	52	50
3.0 mg Cytisine, TID Schedule	50	49
Placebo, TID Schedule	26	26

Primary outcome: Primary Efficacy Analysis of Primary Outcome Measure: Percentage of Expected Cigarettes Smoked Per Participant During Study Treatment

Time frame: Day 1 through Day 25. Least squares mean (Standard Error). Unit: percentage of cigarettes smoked

Measure	1.5 mg Cytisine, Commercial Schedule n = 51	3.0 mg Cytisine, Commercial Schedule n = 50	Placebo, Commercial Schedule n = 25	1.5 mg Cytisine, TID Schedule n = 52	3.0 mg Cytisine, TID Schedule n = 50	Placebo, TID Schedule n = 26
Value	26.62 (3.085)	25.04 (3.123)	47.10 (4.417)	29.40 (3.046)	32.50 (3.105)	35.30 (4.392)

1.5 mg Cytisine, Commercial Schedule vs Placebo, Commercial Schedule: LS Mean Difference vs. Placebo: -20.48 (95% CI -31.141 to -9.821), p = 0.0002, ANOVA
3.0 mg Cytisine, Commercial Schedule vs Placebo, Commercial Schedule: LS Mean Difference vs. Placebo: -22.07 (95% CI -32.791 to -11.342), p < 0.0001, ANOVA
1.5 mg Cytisine, TID Schedule vs Placebo, TID Schedule: LS Mean Difference vs. Placebo: -5.90 (95% CI -16.463 to 4.660), p = 0.2708, ANOVA

Primary outcome: Sensitivity Analysis of Primary Outcome Measure: Analysis for Percentage of Expected Cigarettes Smoked Versus Pooled Placebo Arms, Commercial Schedule

Time frame: Day 1 through Day 25. Least squares mean (Standard Error). Unit: percentage of expected cigarettes smoked

Measure	1.5 mg Cytisine, Commercial Schedule n = 51	3.0 mg Cytisine, Commercial Schedule n = 50	Pooled Placebo n = 51
Value	26.68 (3.065)	25.08 (3.100)	41.29 (3.099)

1.5 mg Cytisine, Commercial Schedule vs Pooled Placebo: LS Mean Difference vs. Placebo: -14.61 (95% CI -23.216 to -6.009), p = 0.0010, ANOVA
3.0 mg Cytisine, Commercial Schedule vs Pooled Placebo: LS Mean Difference vs. Placebo: -16.20 (95% CI -24.862 to -7.548), p = 0.0003, ANOVA

Primary outcome: Sensitivity Analysis of Primary Outcome Measure: Analysis for Percentage of Expected Cigarettes Smoked Versus Pooled Placebo Arms, TID Schedule

Time frame: Day 1 through Day 25. Least squares mean (Standard Error). Unit: percentage of expected cigarettes smoked

Measure	1.5 mg Cytisine, TID Schedule n = 52	3.0 mg Cytisine, TID Schedule n = 50	Pooled Placebo n = 51
Value	29.29 (3.291)	32.41 (3.355)	41.71 (3.358)

1.5 mg Cytisine, TID Schedule vs Pooled Placebo: LS Mean Difference vs. Placebo: -12.41 (95% CI -21.695 to -3.135), p = 0.0091, ANOVA
3.0 mg Cytisine, TID Schedule vs Pooled Placebo: LS Mean Difference vs. Placebo: -9.30 (95% CI -18.667 to 0.075), p = 0.0518, ANOVA

Adverse events

Time frame: From 1st dose of study drug through Week 8 (± 3 days) post-randomization. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1.5 mg Cytisine, Commercial Schedule	0 of 51 (0%)	16 of 51 (31.4%)	0 of 51
3.0 mg Cytisine, Commercial Schedule	0 of 50 (0%)	16 of 50 (32%)	0 of 50
Placebo, Commercial Schedule	0 of 25 (0%)	5 of 25 (20%)	0 of 25
1.5 mg Cytisine, TID Schedule	0 of 52 (0%)	15 of 52 (28.8%)	0 of 52
3.0 mg Cytisine, TID Schedule	0 of 50 (0%)	14 of 50 (28%)	0 of 50
Placebo, TID Schedule	0 of 26 (0%)	8 of 26 (30.8%)	0 of 26

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Mitchell Nides, PhD principal investigator

Los Angeles Clinical Trials

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cytisine and Behavioral support in people with Smoking Cessation, run by Achieve Life Sciences at 8 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 7 inclusion and 15 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 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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. 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 18 May 2020). 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?

Primary Efficacy Analysis of Primary Outcome Measure: Percentage of Expected Cigarettes Smoked Per Participant During Study Treatment (time frame: Day 1 through Day 25). The study lists 3 primary outcomes in all. 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 NCT03709823.

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 18 May 2020.