Pulmonary Arterial HypertensionPhase 3TRANSIT-1NCT02471183

Study to Assess the Tolerability and the Safety of the Transition From Inhaled Treprostinil to Oral Selexipag in Patients With Pulmonary Arterial Hypertension

A Phase 3 study testing Selexipag in people with Pulmonary Arterial Hypertension, run by Actelion at 15 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

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Pulmonary Arterial Hypertension
What is being tested?: Selexipag
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 15 sitesUnited States
Study dates: 12 Oct 2015to 5 Dec 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female patients aged from 18 to 75 years (inclusive) with pulmonary arterial hypertension (PAH).
Etiology of PAH belonging to one of the following subgroups: idiopathic PAH, Heritable PAH, drug or toxin induced, associated with connective tissue disease, associated with HIV infection, associated with congenital heart disease with simple systemic-to-pulmonary shunt at least 1 year after surgical repair.
Women of childbearing potential are eligible only if the following apply: Negative serum pregnancy test at Visit 1 and a negative urine pregnancy test at Visit on Day 1, agreement to undertake monthly urine pregnancy tests during the study and up to 30 days after study drug discontinuation, agreement to use efficient methods of birth control from Visit 1 up to at least 30 days after study treatment discontinuation.
Documented hemodynamic diagnosis of PAH by right heart catheterization (RHC).
Inhaled treprostinil treatment ongoing for at least 90 days and at stable dose for at least 30 days prior to Day 1.
WHO functional class (FC) II or III at Visit 1 and Visit 2.
6-minute walk distance (6MWD) ≥ 300 m at Visit 1.
On background oral PAH therapy for at least 90 days and on a stable dose for 30 days prior to Visit 2. Acceptable concomitant PAH therapies are one or two of the following: a) Endothelin receptor antagonist (ERA), b) Phosphodiesterase type 5 (PDE-5) inhibitor or soluble guanylate cyclase (sGC) stimulator.

Who cannot join

Treatment with any prostacyclin or prostacyclin analogs other than inhaled treprostinil within 90 days before Day 1, or patients scheduled to receive any of these treatments within the duration of the study.
Any hospitalization within 90 days before Day 1.
Worsening in WHO FC within 30 days prior to Day 1.
At any time prior to Day 1, documented moderate or severe obstructive or restrictive lung disease.
Known or suspicion of pulmonary veno-occlusive disease (PVOD).
Anemia: < 80 g/L (5.0 mmol/L) hemoglobin.

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Clinically relevant thyroid disease (hypo- or hyperthyroidism).
Known and documented severe hepatic impairment.
Uncontrolled hypertension.
Sitting systolic blood pressure < 85 mmHg.
Acute myocardial infarction within the last 90 days prior to Visit 1.
History of left-sided heart disease.
Left ventricular disease/dysfunction risk factors.
Documented pericardial effusion within 90 days prior to Visit 1.
Documented severe renal insufficiency.
Receiving or having received any investigational drugs within 90 days before Day 1.
Having received selexipag at any time before Day 1.
Acute or chronic impairment (other than dyspnea), limiting the ability to comply with study requirements.
Recently conducted or planned cardio-pulmonary rehabilitation program based on exercise training during the study.
Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements.
Known concomitant life-threatening disease with a life expectancy < 12 months.
Females who are lactating or pregnant or plan to become pregnant during the study.
Known hypersensitivity to any of the excipients of the drug formulation.

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

University of Michigan Health System
Ann Arbor, Michigan
Emory University
Atlanta, Georgia
Piedmont Healthcare Research Institute
Austell, Georgia
UT Southwestern
Dallas, Texas
Duke Unversity
Durham, North Carolina
Houston Methodist Hospital
Houston, Texas
UCSD Medical Center -La Jolla
La Jolla, California
Kentuckiana Pulmonary Associates
Louisville, Kentucky
Sentara Cardiovascular Research Instistute
Norfolk, Virginia
University of Pennsylvania
Philadelphia, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania
University of Pittsburgh Medical Center Health System
Pittsburgh, Pennsylvania
UCSF Medical Center
San Francisco, California
Washington University School of Medicine
St Louis, Missouri
Harbor UCLA Medical Center
Torrance, California

Other trials in United States

About this study

Official title: Multicenter, Open-label, Single-group Study to Assess the Tolerability and the Safety of the Transition From Inhaled Treprostinil to Oral Selexipag in Adult Patients With Pulmonary Arterial Hypertension

This study enrolls patients with pulmonary arterial hypertension (PAH) treated with inhaled treprostinil. During the study, the treatment with inhaled treprostinil will be tapered off and simultaneously replaced with an oral treatment (selexipag) targeting the disease in a similar way. The purpose of the study is i) to investigate the safety and tolerability of oral selexipag in patients who transition from inhaled treprostinil, ii) to investigate the effects of oral selexipag on PAH severity and exercise ability before and after transition, and iii) to gain new information about the patients experience taking oral selexipag compared to inhaled treprostinil. Study participants may stay in the study until the FDA has granted marketing authorization.

Conditions: Pulmonary Arterial Hypertension
Being tested: Selexipag
Medical subject headings: Pulmonary Arterial Hypertension

What participants receive

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

SelexipagDrug
Also called Uptravi, ACT-293987
Tablets for oral administration containing 200 micrograms (mcg) of selexipag to be administered twice a day. The individual dose is to be established during the first 12 weeks of the study. Doses are in the range from 200 micrograms (1 tablet) to 1,600 micrograms (8 tablets).

Study groups in NCT02471183
Study group	Role	What they receive
Selexipag, Open Label	Experimental	Subjects on inhaled treprostinil treatment participate in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily. From Week 12 up to Week 16, patients continue selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag. Receives: Drug: Selexipag

What is being measured

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

Percentage of Subjects With Sustained Treatment Transition
A sustained treatment transition is considered if the 3 following criteria are met a) being on study treatment (selexipag) at Week 16, and b) not having a study treatment interruption(s) of a total of 8 days or more prior to Week 16, and c) absence of inhaled treprostinil or any prostanoid treatment after Week 8 up to Week 16.
The percentage of subjects with a sustained treatment transition is calculated with 95% confidence interval (CI) using the Clopper-Pearson method.
Measured: At Week 16
Percentage of Subjects With Treatment-emergent Adverse Events (AEs),
Percentage of subjects with treatment-emergent AEs (serious and non serious), regardless of relationship to selexipag
Measured: 26 weeks on average (from the first dose of selexipag up to 30 days after the last dose of selexipag)
Number of Subjects With Adverse Events Leading to Premature Discontinuation of Selexipag
Number of subjects with adverse events leading to premature discontinuation of selexipag is determined from the first dose of selexipag up to the last dose of selexipag
Measured: Up to 22 weeks on average
Absolute Change From Baseline Over Time in Blood Pressure
Both systolic(SBP) and diastolic (DBP) arterial blood pressure were measured in a sitting position after at least 5 minutes of rest at scheduled time points. Median change from baseline to pre-specified post-baseline visits are calculated
Measured: Baseline, Week 4, Week 12, Week 16
Absolute Change From Baseline Over Time in Heart Rate (HR)
Pulse rate is measured after at least 5 minutes of rest in a sitting position. Median change from baseline to pre-specified post-baseline visits are calculated.
Measured: Baseline, Week 4, Week 12, Week 16
Maximal Tolerated Dose
This is the individual maximal tolerated dose (MTD) observed at Week 12 in the subjects still on selexipag at Week 16.
MTD is defined as the dose of selexipag reached with the last dose change up to Week 12
Measured: At Week 12, in subjects still on selexipag at Week 16
Time to Discontinuation of Inhaled Treprostinil.
Median time from baseline (Day1) to the end of down-titration of inhaled treprostinil is calculated
Measured: Baseline to Week 16

Secondary outcomes (4)

Percentage of Subjects With WHO Functional Class (FC) Change From Baseline
The World Health Organization (WHO) defines 4 classes to classify the functional status of patients with pulmonary hypertension:
Class I (FC I): No limitation of physical activity. Class II (FC II): Slight limitation of physical activity. Class III (FC III): Marked limitation of physical activity. Class IV (FC IV): Inability to carry out any physical activity without symptoms.
Number of patients with improvement (shift from a higher to a lower class), worsening (shift from a lower to a higher class) or no change in WHO functional class at end of study compared to baseline are determined.
Measured: Baseline and Week 16
Absolute Change in 6-minute Walk Distance (6MWD) at Trough
The 6MWT is a non-encouraged test, which measures the distance (in meters) covered by the subject during a 6-minute walk. It is performed in a 30-meters long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones, with the permission to slow down, rest, or stop if needed.
Absolute change from baseline to Week 16 in 6MWD is measured at trough levels of inhaled treprostinil and/or selexipag. The trough level of inhaled treprostinil is defined as the last dose having been taken not less than 4 hours and not more than 48 hours prior to the 6MWT at Visit 1 (screening). The trough level of selexipag was defined as the last dose having been taken not less than 8 hours and not more than 7 days prior to the 6MWT at Visit 5 (Week 16).
Measured: Baseline and Week 16
Percentage of Patients With Change in 6-minute Walk Distance (6MWD)
Percentage of patients with an increase (> 8% of baseline), maintenance (+/- 8% of baseline), or decrease (< -8% of baseline) in their 6MWD (at trough) from baseline to Week 16. The ± 8% boundaries for change in 6MWD reflect the approximately 8% coefficient of variation in the reproducibility of the 6MWD.
The trough level of inhaled treprostinil is defined as the last dose having been taken not less than 4 hours and not more than 48 hours prior to the 6MWD test at Visit 1 (screening). The trough level of selexipag was defined as the last dose having been taken not less than 8 hours and not more than 7 days prior to the 6MWD test at Visit 5 (Week 16).
Measured: Baseline and Week 16
Geometric Mean of the Ratio in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) of Week 16 to Baseline
Changes in NT-proBNP levels in plasma are expressed by the geometric mean of the ratio of Week 16 to baseline
Measured: Baseline and Week 16

Timeline

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

12 Oct 20155 Dec 2016

First posted15 Jun 2015 (estimated)
Study start12 Oct 2015
Primary completion5 Dec 2016
Study completion5 Dec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pulmonary Arterial HypertensionStudies 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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02471183
Sponsor's protocol ID: AC-065A304
Acronym: TRANSIT-1
Status last verified: Dec 2017
First submitted: 11 Jun 2015
Last updated: 23 Jan 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Frost A, Janmohamed M, Fritz JS, McConnell JW, Poch D, Fortin TA, Miller CE, Chin KM, Fisher M, Eggert M, McEvoy C, Benza RL, Farber HW, Kim NH, Pfister T, Shiraga Y, McLaughlin V. Safety and tolerability of transition from inhaled treprostinil to oral selexipag in pulmonary arterial hypertension: Results from the TRANSIT-1 study. J Heart Lung Transplant. 2019 Jan;38(1):43-50. doi: 10.1016/j.healun.2018.09.003. Epub 2018 Sep 12.
PubMed 30391194

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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Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter, Open-label, Single-group Study to Assess the Tolerability and the Safety of the Transition From Inhaled Treprostinil to Oral Selexipag in Adult Patients With Pulmonary Arterial Hypertension
ClinicalTrials.gov ID: NCT02471183
Acronym / sponsor ID: TRANSIT-1 / AC-065A304
Conditions: Pulmonary Arterial Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: ActelionIndustry (pharma, biotech, devices)
Study start: 12 Oct 2015 (actual)
Primary completion: 5 Dec 2016 (actual)
Study completion: 5 Dec 2016 (actual)
First posted: 15 Jun 2015 (estimated)
Results: Posted 28 Dec 2017

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Selexipag, Open Label	Experimental	Drug: SelexipagSubjects on inhaled treprostinil treatment participate in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily. From Week 12 up to Week 16, patients continue selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Male and female patients aged from 18 to 75 years (inclusive) with pulmonary arterial hypertension (PAH).
Etiology of PAH belonging to one of the following subgroups: idiopathic PAH, Heritable PAH, drug or toxin induced, associated with connective tissue disease, associated with HIV infection, associated with congenital heart disease with simple systemic-to-pulmonary shunt at least 1 year after surgical repair.
Women of childbearing potential are eligible only if the following apply: Negative serum pregnancy test at Visit 1 and a negative urine pregnancy test at Visit on Day 1, agreement to undertake monthly urine pregnancy tests during the study and up to 30 days after study drug discontinuation, agreement to use efficient methods of birth control from Visit 1 up to at least 30 days after study treatment discontinuation.
Documented hemodynamic diagnosis of PAH by right heart catheterization (RHC).
Inhaled treprostinil treatment ongoing for at least 90 days and at stable dose for at least 30 days prior to Day 1.

Key exclusion criteria (23 listed)

Treatment with any prostacyclin or prostacyclin analogs other than inhaled treprostinil within 90 days before Day 1, or patients scheduled to receive any of these treatments within the duration of the study.
Any hospitalization within 90 days before Day 1.
Worsening in WHO FC within 30 days prior to Day 1.
At any time prior to Day 1, documented moderate or severe obstructive or restrictive lung disease.
Known or suspicion of pulmonary veno-occlusive disease (PVOD).

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
SelexipagAlso: Uptravi, ACT-293987Tablets for oral administration containing 200 micrograms (mcg) of selexipag to be administered twice a day. The individual dose is to be established during the first 12 weeks of the study. Doses are in the range from 200 micrograms (1 tablet) to 1,600 micrograms (8 tablets).	Drug	Selexipag, Open Label

Primary outcome

Percentage of Subjects With Sustained Treatment Transition
Time frame: At Week 16
A sustained treatment transition is considered if the 3 following criteria are met a) being on study treatment (selexipag) at Week 16, and b) not having a study treatment interruption(s) of a total of 8 days or more prior to Week 16, and c) absence of inhaled treprostinil or any prostanoid treatment after Week 8 up to Week 16. The percentage of subjects with a sustained treatment transition is calculated with 95% confidence interval (CI) using the Clopper-Pearson method.
Percentage of Subjects With Treatment-emergent Adverse Events (AEs),
Time frame: 26 weeks on average (from the first dose of selexipag up to 30 days after the last dose of selexipag)
Percentage of subjects with treatment-emergent AEs (serious and non serious), regardless of relationship to selexipag
Number of Subjects With Adverse Events Leading to Premature Discontinuation of Selexipag
Time frame: Up to 22 weeks on average
Number of subjects with adverse events leading to premature discontinuation of selexipag is determined from the first dose of selexipag up to the last dose of selexipag
Absolute Change From Baseline Over Time in Blood Pressure
Time frame: Baseline, Week 4, Week 12, Week 16
Both systolic(SBP) and diastolic (DBP) arterial blood pressure were measured in a sitting position after at least 5 minutes of rest at scheduled time points. Median change from baseline to pre-specified post-baseline visits are calculated
Absolute Change From Baseline Over Time in Heart Rate (HR)
Time frame: Baseline, Week 4, Week 12, Week 16
Pulse rate is measured after at least 5 minutes of rest in a sitting position. Median change from baseline to pre-specified post-baseline visits are calculated.
Maximal Tolerated Dose
Time frame: At Week 12, in subjects still on selexipag at Week 16
This is the individual maximal tolerated dose (MTD) observed at Week 12 in the subjects still on selexipag at Week 16. MTD is defined as the dose of selexipag reached with the last dose change up to Week 12
Time to Discontinuation of Inhaled Treprostinil.
Time frame: Baseline to Week 16
Median time from baseline (Day1) to the end of down-titration of inhaled treprostinil is calculated

4 secondary outcomes

Percentage of Subjects With WHO Functional Class (FC) Change From Baseline
Time frame: Baseline and Week 16
Absolute Change in 6-minute Walk Distance (6MWD) at Trough
Time frame: Baseline and Week 16
Percentage of Patients With Change in 6-minute Walk Distance (6MWD)
Time frame: Baseline and Week 16
Geometric Mean of the Ratio in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) of Week 16 to Baseline
Time frame: Baseline and Week 16

Results and safety

Results posted to the registry on 28 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Selexipag	34	32

Primary outcome: Percentage of Subjects With Sustained Treatment Transition

Time frame: At Week 16. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Selexipag n = 34
Value	82.4 (65.5 to 93.2)

Population analysed: All subjects who took at least one dose of selexipag were included in the safety analyses

Primary outcome: Percentage of Subjects With Treatment-emergent Adverse Events (AEs),

Time frame: 26 weeks on average (from the first dose of selexipag up to 30 days after the last dose of selexipag). Number. Unit: Percentage of participants

Measure	Selexipag n = 34
Value	97.1

Population analysed: All subjects who took at least one dose of selexipag were included in the safety analyses

Primary outcome: Number of Subjects With Adverse Events Leading to Premature Discontinuation of Selexipag

Time frame: Up to 22 weeks on average. Count of participants. Unit: Participants

Measure	Selexipag n = 34
Value	3

Population analysed: All subjects who took at least one dose of selexipag were included in the safety analyses

Primary outcome: Absolute Change From Baseline Over Time in Blood Pressure

Time frame: Baseline, Week 4, Week 12, Week 16. Median (Full Range). Unit: mmHg

Measure	Selexipag n = 34
SBP change from baseline at week 4	1.00 (-32.0 to 59.0)
SBP change from baseline at week 12	-3.00 (-28.0 to 35.0)
SBP change from baseline at week 16	-4.00 (-24.0 to 25.0)
DBP change from baseline at week 4	-3.00 (-26.0 to 34.0)
DBP change from baseline at week 12	-4.00 (-30.0 to 48.0)
DBP change from baseline at week 16	-6.00 (-21.0 to 15.0)

Population analysed: All subjects who took at least one dose of selexipag were included in the safety analyses

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From study treatment initiation up to 30 days after study treatment discontinuation. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Selexipag	2 of 34 (5.9%)	33 of 34 (97.1%)	0 of 34

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30391194Frost A, Janmohamed M, Fritz JS, McConnell JW, Poch D, Fortin TA, Miller CE, Chin KM, Fisher M, Eggert M, McEvoy C, Benza RL, Farber HW, Kim NH, Pfister T, Shiraga Y, McLaughlin V. Safety and tolerability of transition from inhaled treprostinil to oral selexipag in pulmonary arterial hypertension: Results from the TRANSIT-1 study. J Heart Lung Transplant. 2019 Jan;38(1):43-50. doi: 10.1016/j.healun.2018.09.003. Epub 2018 Sep 12.

Related trials for Pulmonary Arterial Hypertension

Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Selexipag in people with Pulmonary Arterial Hypertension, run by Actelion at 15 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 8 inclusion and 23 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 23 Jan 2018. 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 28 Dec 2017). 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?

Percentage of Subjects With Sustained Treatment Transition (time frame: At Week 16). The study lists 7 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 NCT02471183, 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 23 Jan 2018.