Prostatic HyperplasiaPhase 1NCT02509104
Bioavailability Study of Fixed Dose Combination (FDC) Dutasteride and Tamsulosin Hydrochloride (HCl) Relative to One Dutasteride and One Tamsulosin HCl Tablet in Healthy Male Subjects
A Phase 1 study testing FDC capsule of dutasteride and tamsulosin and Dutasteride soft gelatine capsule and tamsulosin HCl oral disintegrating tablet in people with Prostatic Hyperplasia, run by GlaxoSmithKline at 1 site in United States.
Trial summary
The primary objective of this study is to determine the bioavailability of a FDC capsule formulation of dutasteride and tamsulosin hydrochloride (0.5 milligram [mg]/0.2 mg) relative to coadministration of one dutasteride 0.5 mg capsule and one tamsulosin HCl 0.2 mg tablet in healthy male subjects in fed and fasted… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostatic Hyperplasia
- What is being tested?
- FDC capsule of dutasteride and tamsulosin and Dutasteride soft gelatine capsule and tamsulosin HCl oral disintegrating tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2015to 10 Oct 2015
- Phase
- Phase 1
- 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 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male subjects aged between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator in consultation with the Medical Monitor if required agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Body weight >= 50 kilogram (kg) and body mass index (BMI) within the range 18 to 30 kg per meter square (m^2) (inclusive).
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
Who cannot join
- Alanine aminotransferase (ALT) and bilirubin >1.5xUpper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent).
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- History of postural hypotension, dizziness, poor hydration, vertigo, vaso-vagal reactions or any other signs and symptoms of orthostasis, which in the opinion of the investigator could be exacerbated by tamsulosin and result in putting the subject at risk of injury.
- History of diabetes or peptic ulcer disease which is uncontrolled by medical management.
- Current or history of: Breast cancer or clinical breast examination finding suggestive of breast malignancy; Malignancy within the past five years, except for basal cell carcinoma of the skin. Subjects with a prior malignancy who have had no evidence of disease for at least the past 5 years are eligible.
- Prior medical history or evidence of prostate cancer (e.g., positive biopsy, or suspicious ultrasound, or suspicious digital rectal examination [DRE]). Patients with suspicious ultrasound or DRE who have had a negative biopsy within the preceding 6 months and stable prostate specific antigen (PSA) are eligible for the study.
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- Based on averaged corrected QT (QTc) values of triplicate ECGs obtained over a brief recording period: QTcF > 450 millisecond (msec).
- Subjects must abstain from taking prescription or non-prescription drugs (including vitamins and dietary or herbal supplements), within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication until completion of the follow-up visit, unless in the opinion of the Investigator and sponsor the medication will not interfere with the Study.
- History of regular alcohol consumption within 6 months of the study defined as: For United States sites: an average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 gram (g) of alcohol: 12 ounces (360 millilitre [mL]) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
- Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.
- A positive pre-study drug/alcohol screen.
- A positive test for human immunodeficiency virus (HIV) antibody.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL over the duration of the study.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 50 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Unable to swallow and retain oral medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Single Dose, Two-way Crossover Study to Determine the Bioavailability of One Fixed Dose Combination Capsule Formulation of Dutasteride and Tamsulosin Hydrochloride (0.5 mg/0.2 mg) Relative to Coadministration of One Dutasteride 0.5 mg Capsule and One Tamsulosin Hydrochloride 0.2 mg Tablet in Healthy Male Subjects in the Fed and Fasted States
The primary objective of this study is to determine the bioavailability of a FDC capsule formulation of dutasteride and tamsulosin hydrochloride (0.5 milligram [mg]/0.2 mg) relative to coadministration of one dutasteride 0.5 mg capsule and one tamsulosin HCl 0.2 mg tablet in healthy male subjects in fed and fasted states. This is an open-label, randomized, single dose, two-way crossover study enrolling healthy male subjects, split into fasted (Cohort 1) and fed (Cohort 2) conditions. In both cohorts, one FDC capsule formulation of dutasteride 0.5 mg/tamsulosin HCl 0.2 mg will be administered in one treatment period and the coadministration of dutasteride and tamsulosin hydrochloride in a different treatment period. Each subject enrolled will be allowed to participate in only one cohort (i.e, will receive treatment under fasted or fed conditions) and will participate in both treatment periods. The two treatment periods will be separated by a minimum washout period of 28 days. The total duration in the study for each subject will be approximately 2.5 months from screening to the final follow-up visit.
- Conditions
- Prostatic Hyperplasia
- Being tested
- FDC capsule of dutasteride and tamsulosin, Dutasteride soft gelatine capsule and tamsulosin HCl oral disintegrating tablet
- Keywords
- Bioavailability, Dutasteride, Healthy Male Subjects, Fixed Dose Combination
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDC capsule of dutasteride and tamsulosinDrug
Each FDC capsule contains a mixture of dutasteride formulation (equivalent to 0.5 mg dutasteride) and tamsulosin (equivalent to 0.2 mg tamsulosin) and its physical appearance is hard shell capsule.
Dutasteride soft gelatine capsule and tamsulosin HCl oral disintegrating tabletDrug
Coadministration of dutasteride soft gelatine capsule and tamsulosin HCl oral disintegrating tablet. Each soft gelatine capsule consist of 0.5 mg of dutasteride and physical appearance is Oblong, size 6, dull yellow capsule. Each oral disintegrating tablet consist of 0.2 mg of tamsulosin and its physical appearance is white, round standard convex.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Fasted condition | Experimental | Each subject will receive both treatments A and B in either of period 1 or 2 with a washout period of 28 days between treatment periods. Subjects will receive the study treatments under fasting conditions. Receives: Drug: FDC capsule of dutasteride and tamsulosin; Drug: Dutasteride soft gelatine capsule and tamsulosin HCl oral disintegrating tablet |
| Cohort 2 Fed condition | Experimental | Each subject will receive both treatment A and B in either of period 1 or 2 with a washout period of 28 days between treatment periods. Subjects will receive the study treatments under fed (high fat breakfast) conditions. Receives: Drug: FDC capsule of dutasteride and tamsulosin; Drug: Dutasteride soft gelatine capsule and tamsulosin HCl oral disintegrating tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed serum concentration (Cmax) for dutasteride and tamsulosin
Blood samples for PK analysis will be collected for each subject at the following time points: Pre-dose, 15 minutes (min), 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48 \& 72 hours post dose in both the treatment periods. Cmax will be determined for tamsulosin and dutasteride.
Measured: Days 1 to 4 of both treatment periods
Area under the serum concentration-time curve (AUC) zero to time 't' (AUC[0-t]) for tamsulosin and dutasteride; AUC 0 to infinity (AUC 0-inf) will be determined for tamsulosin as data permit
Blood samples for PK analysis will be collected for each subject at the following time points: Pre-dose, 15 minutes (min), 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48 \& 72 hours post dose in both the treatment periods. AUC 0-t will be determined for tamsulosin and dutasteride. Additionally, AUC 0-inf will be determined for tamsulosin as data permit.
Measured: Days 1 to 4 of both treatment periods
Secondary outcomes (5)
Time of occurrence of Cmax (Tmax) for dutasteride and tamsulosin
Blood samples for PK analysis will be collected for each subject at the following time points: Pre-dose, 15 minutes (min), 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48 \& 72 hours post dose in both the treatment periods. Tmax will be determined for tamsulosin and dutasteride.
Measured: Days 1 to 4 of both treatment periods
Terminal phase half-life (t1/2) for tamsulosin
Blood samples for PK analysis of tamsulosin and dutasteride will be collected for each subject at the following time points: Pre-dose, 15 minutes (min), 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48 \& 72 h post dose in both the treatment periods. Terminal phase half-life will be determined for tamsulosin.
Measured: Days 1 to 4 of both treatment periods
Number of participants with adverse events (AE) /serious adverse event (SAE) as a measure of safety and tolerability
AEs and SAEs will be collected from the start of study Treatment until the follow-up contact.
Measured: From start of study treatment until follow-up contact (up to Week 7)
Composite of vital signs as a measure of safety and tolerability
Vital signs will be measured in semi-supine position after 5 minutes rest and will include temperature, systolic and diastolic blood pressure and pulse rate.
Measured: Screening visit, Day -1, and Day 2 (in both treatment periods) and follow-up visit (up to 2.5 months).
Composite of 12-lead electrocardiogram (ECG) assessment as a safety measure
ECG measurement include heart rate and measures PR, QRS, QT, and QT interval corrected using the Fridericia's formula (QTcF) intervals.
Measured: Screening, Day 1 and Day 2 in both treatment periods and follow-up visit (up to 2.5 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2015 (estimated)
- Study start30 Jul 2015
- Primary completion10 Oct 2015
- Study completion10 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509104
- Sponsor's protocol ID
- 201897
- Status last verified
- Jun 2018
- First submitted
- 23 Jul 2015
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Burns O, Zhu J, Manyak MJ, Ravindranath R, Koosha F, Haque N, Chung S. Relative Bioavailability of Fixed-Dose Combinations of Tamsulosin and Dutasteride: Results From 2 Randomized Trials in Healthy Male Volunteers. Clin Pharmacol Drug Dev. 2018 May;7(4):422-434. doi: 10.1002/cpdd.380. Epub 2017 Aug 11.
PubMed 28800206
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single Dose, Two-way Crossover Study to Determine the Bioavailability of One Fixed Dose Combination Capsule Formulation of Dutasteride and Tamsulosin Hydrochloride (0.5 mg/0.2 mg) Relative to Coadministration of One Dutasteride 0.5 mg Capsule and One Tamsulosin Hydrochloride 0.2 mg Tablet in Healthy Male Subjects in the Fed and Fasted States
- ClinicalTrials.gov ID
- NCT02509104
- Acronym / sponsor ID
- 201897
- Conditions
- Prostatic Hyperplasia
- Keywords
- Bioavailability, Dutasteride, Healthy Male Subjects, Fixed Dose Combination
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2015 (actual)
- Primary completion
- 10 Oct 2015 (actual)
- Study completion
- 10 Oct 2015 (actual)
- First posted
- 27 Jul 2015 (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 primary objective of this study is to determine the bioavailability of a FDC capsule formulation of dutasteride and tamsulosin hydrochloride (0.5 milligram [mg]/0.2 mg) relative to coadministration of one dutasteride 0.5 mg capsule and one tamsulosin HCl 0.2 mg tablet in healthy male subjects in fed and fasted states. This is an open-label, randomized, single dose, two-way crossover study enrolling healthy male subjects, split into fasted (Cohort 1) and fed (Cohort 2) conditions. In both cohorts, one FDC capsule formulation of dutasteride 0.5 mg/tamsulosin HCl 0.2 mg will be administered in one treatment period and the coadministration of dutasteride and tamsulosin hydrochloride in a different treatment period. Each subject enrolled will be allowed to participate in only one cohort (i.e, will receive treatment under fasted or fed conditions) and will participate in both treatment periods. The two treatment periods will be separated by a minimum washout period of 28 days. The total duration in the study for each subject will be approximately 2.5 months from screening to the final follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Fasted condition | Experimental | Drug: FDC capsule of dutasteride and tamsulosin, Drug: Dutasteride soft gelatine capsule and tamsulosin HCl oral disintegrating tabletEach subject will receive both treatments A and B in either of period 1 or 2 with a washout period of 28 days between treatment periods. Subjects will receive the study treatments under fasting conditions. |
| Cohort 2 Fed condition | Experimental | Drug: FDC capsule of dutasteride and tamsulosin, Drug: Dutasteride soft gelatine capsule and tamsulosin HCl oral disintegrating tabletEach subject will receive both treatment A and B in either of period 1 or 2 with a washout period of 28 days between treatment periods. Subjects will receive the study treatments under fed (high fat breakfast) conditions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male subjects aged between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator in consultation with the Medical Monitor if required agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Body weight >= 50 kilogram (kg) and body mass index (BMI) within the range 18 to 30 kg per meter square (m^2) (inclusive).
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
Key exclusion criteria (17 listed)
- Alanine aminotransferase (ALT) and bilirubin >1.5xUpper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent).
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- History of postural hypotension, dizziness, poor hydration, vertigo, vaso-vagal reactions or any other signs and symptoms of orthostasis, which in the opinion of the investigator could be exacerbated by tamsulosin and result in putting the subject at risk of injury.
- History of diabetes or peptic ulcer disease which is uncontrolled by medical management.
- Current or history of: Breast cancer or clinical breast examination finding suggestive of breast malignancy; Malignancy within the past five years, except for basal cell carcinoma of the skin. Subjects with a prior malignancy who have had no evidence of disease for at least the past 5 years are eligible.
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 |
|---|---|---|
| FDC capsule of dutasteride and tamsulosinEach FDC capsule contains a mixture of dutasteride formulation (equivalent to 0.5 mg dutasteride) and tamsulosin (equivalent to 0.2 mg tamsulosin) and its physical appearance is hard shell capsule. | Drug | Cohort 1 Fasted condition, Cohort 2 Fed condition |
| Dutasteride soft gelatine capsule and tamsulosin HCl oral disintegrating tabletCoadministration of dutasteride soft gelatine capsule and tamsulosin HCl oral disintegrating tablet. Each soft gelatine capsule consist of 0.5 mg of dutasteride and physical appearance is Oblong, size 6, dull yellow capsule. Each oral disintegrating tablet consist of 0.2 mg of tamsulosin and its physical appearance is white, round standard convex. | Drug | Cohort 1 Fasted condition, Cohort 2 Fed condition |
Primary outcome
Maximum observed serum concentration (Cmax) for dutasteride and tamsulosin
Time frame: Days 1 to 4 of both treatment periods
Blood samples for PK analysis will be collected for each subject at the following time points: Pre-dose, 15 minutes (min), 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48 \& 72 hours post dose in both the treatment periods. Cmax will be determined for tamsulosin and dutasteride.
Area under the serum concentration-time curve (AUC) zero to time 't' (AUC[0-t]) for tamsulosin and dutasteride; AUC 0 to infinity (AUC 0-inf) will be determined for tamsulosin as data permit
Time frame: Days 1 to 4 of both treatment periods
Blood samples for PK analysis will be collected for each subject at the following time points: Pre-dose, 15 minutes (min), 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48 \& 72 hours post dose in both the treatment periods. AUC 0-t will be determined for tamsulosin and dutasteride. Additionally, AUC 0-inf will be determined for tamsulosin as data permit.
5 secondary outcomes
Time of occurrence of Cmax (Tmax) for dutasteride and tamsulosin
Time frame: Days 1 to 4 of both treatment periods
Terminal phase half-life (t1/2) for tamsulosin
Time frame: Days 1 to 4 of both treatment periods
Number of participants with adverse events (AE) /serious adverse event (SAE) as a measure of safety and tolerability
Time frame: From start of study treatment until follow-up contact (up to Week 7)
Composite of vital signs as a measure of safety and tolerability
Time frame: Screening visit, Day -1, and Day 2 (in both treatment periods) and follow-up visit (up to 2.5 months).
Composite of 12-lead electrocardiogram (ECG) assessment as a safety measure
Time frame: Screening, Day 1 and Day 2 in both treatment periods and follow-up visit (up to 2.5 months).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- Derived from this study: PubMed 28800206Burns O, Zhu J, Manyak MJ, Ravindranath R, Koosha F, Haque N, Chung S. Relative Bioavailability of Fixed-Dose Combinations of Tamsulosin and Dutasteride: Results From 2 Randomized Trials in Healthy Male Volunteers. Clin Pharmacol Drug Dev. 2018 May;7(4):422-434. doi: 10.1002/cpdd.380. Epub 2017 Aug 11.
- Results for study 201897 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FDC capsule of dutasteride and tamsulosin and Dutasteride soft gelatine capsule and tamsulosin HCl oral disintegrating tablet in people with Prostatic Hyperplasia, run by GlaxoSmithKline at 1 site 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 17 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 19 Jun 2018. 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 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum observed serum concentration (Cmax) for dutasteride and tamsulosin (time frame: Days 1 to 4 of both treatment periods). The study lists 2 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 NCT02509104, which also lists 1 linked publication.
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 19 Jun 2018.