Pulmonary Arterial HypertensionPhase 3TRITONNCT02558231
The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension
A Phase 3 study testing Macitentan, Tadalafil and Selexipag in people with Pulmonary Arterial Hypertension, run by Actelion at 58 sites in 15 countries.
Trial summary
The objective of this clinical trial is to compare the efficacy and safety of an initial triple oral treatment regimen (macitentan, tadalafil, selexipag) versus an initial dual oral treatment regimen (macitentan, tadalafil, placebo) in newly diagnosed, treatment-naïve patients with pulmonary arterial hypertension. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Macitentan, Tadalafil and Selexipag
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 247 participants
- Where
- 58 sitesin 15 countries
- Study dates
- 1 May 2016to 20 Apr 2020
- 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
- Signed informed consent prior to any study-mandated procedure.
- Male or female ≥ 18 and ≤ 75 years of age at screening.
- Initial PAH diagnosis < 6 months prior to enrollment.
- RHC performed between Day -28 and Day 1, meeting all the following criteria:
- Mean pulmonary artery pressure (mPAP) ≥ 25 mmHg.
- Pulmonary artery wedge pressure or left ventricular end-diastolic pressure ≤ 15 mmHg.
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- PVR ≥ 480 dyn•sec/cm5 (≥ 6 Wood Units).
- Negative vasoreactivity test mandatory in idiopathic, heritable, and drug/toxin induced PAH (at this or a previous RHC).
- Symptomatic PAH belonging to one of the following subgroups:
- Idiopathic.
- Heritable.
- Drug or toxin induced.
- Associated with one of the following: connective tissue disease; HIV infection; congenital heart disease.
- 6-minute walk distance (6MWD) ≥ 50 m at screening.
- Women of childbearing potential must not be pregnant, must perform regular pregnancy tests, and use reliable contraception.
Who cannot join
- Any PAH-specific drug therapy at any time.
- Cardio pulmonary rehabilitation program based on exercise (planned, or started ≤ 12 weeks prior to Day 1).
- Body mass index (BMI) > 40 kg/m2 at screening.
- Presence of three or more of the following risk factors for heart failure with preserved ejection fraction at screening:
- BMI > 30 kg/m2.
- Diabetes mellitus of any type.
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- Essential hypertension.
- Coronary artery disease, i.e., any of the following:
- History of stable angina or
- More than 50% stenosis in a coronary artery (by coronary angiography) or
- History of myocardial infarction or
- History of or planned coronary artery bypass grafting and/or coronary artery stenting.
- Acute myocardial infarction ≤ 12 weeks prior to screening.
- Stroke ≤ 12 weeks prior to screening.
- Known permanent atrial fibrillation.
- SBP < 90 mmHg at screening or Day 1.
- Ongoing or planned treatment with organic nitrates and/or doxazosin.
- Presence of one or more of the following signs of relevant lung disease at any time up to screening:
- Diffusing capacity of the lung for carbon monoxide (DLCO) < 40% of predicted (eligible only if no or mild interstitial lung disease on computed tomography).
- Forced vital capacity (FVC) < 60% of predicted.
- Forced expiratory volume in one second (FEV1) < 60% of predicted.
- Known or suspected pulmonary veno-occlusive disease (PVOD).
- Documented severe hepatic impairment (with or without cirrhosis) according to National Cancer Institute organ dysfunction working group criteria, defined as total bilirubin > 3 × upper limit of the normal range (ULN) accompanied by aspartate aminotransferase (AST) > ULN (assessed by central laboratory at screening); and/or Child-Pugh Class C.
- Serum AST and/or alanine aminotransferase (ALT) > 3 × ULN (assessed by central laboratory at screening).
- Severe renal impairment (estimated creatinine clearance ≤ 30 mL/min/1.73 m2) assessed by central laboratory at screening.
- Ongoing or planned dialysis.
- Hemoglobin < 100 g/L assessed by central laboratory at screening.
- Known or suspected uncontrolled thyroid disease (hypo- or hyperthyroidism).
- Loss of vision in one or both eyes because of non-arteritic ischemic optic neuropathy (NAION).
- Treatment with strong inducers of cytochrome P450 3A4 (CYP3A4; e.g., carbamazepine, rifampin, rifampicin, rifabutin, rifapentin, phenobarbital, phenytoin, and St. John's wort) ≤ 28 days prior to Day 1.
- Treatment with strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, nefazodone, ritonavir, and saquinavir) and/or strong inhibitors of CYP2C8 (e.g., gemfibrozil) ≤ 28 days prior to Day 1.
- Treatment with another investigational drug (planned, or taken ≤ 12 weeks prior to Day 1).
- Hypersensitivity to any of the 3 study treatments or any excipient of their formulations.
- Pregnancy, breastfeeding, or intention to become pregnant during the study.
- Concomitant life-threatening disease with a life expectancy < 12 months.
- Alcohol abuse.
- Any factor or condition likely to affect protocol compliance of the subject, as judged by the investigator.
Trial locations and contacts
58 sites in 15 countries.
58 sites in 15 countries
United States20 sites
University of New Mexico Hospital
Albuquerque, New Mexico, 87106
Piedmont Pulmonary and Critical Care Research
Atlanta, Georgia, 30309
Johns Hopkins School of Medicine
Baltimore, Maryland, 21205
Tufts Medical Center
Boston, Massachusetts, 02111-1552
Boston University Medical Center
Boston, Massachusetts, 02118-2526
Northwestern University
Chicago, Illinois, 60611
The Christ Hospital
Cincinnati, Ohio, 45219-2906
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-8550
Houston Methodist Hospital
Houston, Texas, 77030
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
UCSD Health Sciences
La Jolla, California, 92093
UCLA Medical Center
Los Angeles, California, 90095
Kentuckiana Pulmonary Associates
Louisville, Kentucky, 40202
LSU Health Sciences Center
New Orleans, Louisiana, 70112
Arizona Pulmonary Specialists, LTD
Phoenix, Arizona, 85012
Allegheny General Hospital of Research
Pittsburgh, Pennsylvania, 15212
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
Washington University School of Medicine
Saint Louis, Michigan, 63110
Cleveland Clinic Florida
Weston, Florida, 33331
Canada7 sites
University of Calgary
Calgary, T1Y 6J4
London Health Sciences Centre - Victoria Hospital
London, Ontario, N6A 5W9
Jewish General Hospital
Montreal, Quebec, H3T 1E2
University of Ottawa Heart Institute
Ottawa, K1Y 4W7
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, G1V 4G5
University of Toronto
Toronto, Ontario, M5G 2N2
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Germany7 sites
Universitätsklinikum Köln
Cologne, 50924
Unversitätsklinikum Carl Gustav Carus
Dresden, 01307
Universitätsklinikum Giessen
Giessen, 35392
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Medizinische Hochschule Hannover
Hanover, 30625
Universitätsklinikum Heidelberg
Heidelberg, 69126
Universitätsklinikum Regensburg
Regensburg, 93053
United Kingdom4 sites
Golden Jubilee National Hospital
Clydebank, G81 4DY
The Royal Free Hospital
London, NW3 2QG
Royal Brompton Hospital
London, SW3 6NP
Hammersmith Hospital
London, W12 0HS
Austria3 sites
LKH -Universität Klinkum Graz
Graz, 8036
Krankenhaus der Elisabethinen Linz
Linz, 4020
AKH Wien
Vienna, 1090
Sweden3 sites
Skånes universitetssjukhus Lund
Lund, 221 85
Norrlands universitetssjukhus
Umeå, 901 85
Kardiologkliniken
Uppsala, 751 85
Australia2 sites
Royal Prince Albert Hospital
Camperdown, New South Wales, 2050
St. Vincents Hospital Sydney
Darlinghurst, New South Wales, 2010
Belgium2 sites
Hôpital Erasme
Brussels, 1070
UZ Leuven - Campus Gasthuisberg
Leuven, 3000
Denmark2 sites
Aarhus University Hospital Skejby
Aarhus, 8200
Rigshospitalet Copenhagen
Copenhagen, 2100
Netherlands2 sites
VUmc Amsterdam
Amsterdam, 1081 HV
Maastricht University Medical Center
Maastricht, 6229 HX
Spain2 sites
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital 12 de Octubre
Madrid, 28041
About this study
Official title: The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension: A Multi-center, Double-blind, Placebo-controlled, Phase 3b Study
The objective of this clinical trial is to compare the efficacy and safety of an initial triple oral treatment regimen (macitentan, tadalafil, selexipag) versus an initial dual oral treatment regimen (macitentan, tadalafil, placebo) in newly diagnosed, treatment-naïve patients with pulmonary arterial hypertension.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Macitentan, Tadalafil, 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.
MacitentanDrug
Used open-label in both arms, 10 mg tablet, 1 tablet u.i.d.
TadalafilDrug
Used open-label in both arms, 20 mg tablet, 1-2 tablets u.i.d.
SelexipagDrug
Used double-blind in the triple oral treatment arm, 200 microgram tablet, 1-8 tablets b.i.d.
| Study group | Role | What they receive |
|---|---|---|
| Triple oral combination treatment | Experimental | Macitentan, tadalafil, and selexipag Receives: Drug: Macitentan; Drug: Tadalafil; Drug: Selexipag |
| Dual oral combination treatment | Placebo comparator | Macitentan, tadalafil, and placebo Receives: Drug: Macitentan; Drug: Tadalafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 26 in Pulmonary Vascular Resistance (PVR)
Change from baseline to Week 26 in PVR was expressed as the ratio of Week 26 to baseline PVR value (Week 26 divided by baseline) using re-calculated PVR. PVR was determined by right heart catheterization (RHC). A geometric least square mean ratio of Week 26 to baseline PVR less than (<) 1 corresponds to a reduction in PVR from baseline. Missing values were imputed using a last observation carried forward (LOCF) approach.
Measured: Baseline, Week 26
Secondary outcomes (9)
Change From Baseline to Week 26 in 6-minute Walk Distance (6MWD)
The change from baseline to Week 26 in 6MWD was calculated as Week 26 minus baseline. The test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. Missing values were imputed using a LOCF approach.
Measured: Baseline, Week 26
Change From Baseline to Week 26 in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) Levels
The change from baseline to Week 26 in NT-proBNP was expressed as the ratio of Week 26 to baseline NT-proBNP (Week 26 divided by baseline). A geometric least square mean ratio of Week 26 to baseline NT-proBNP <1 corresponds to a reduction in NT-proBNP from baseline. Missing values were imputed using a LOCF approach.
Measured: Baseline, Week 26
Percentage of Participants With Absence of Worsening From Baseline to Week 26 in World Health Organization (WHO) Functional Class (FC)
WHO FC is a classification graded from Class I to IV which reflects disease severity based on symptoms. Worsening was defined as death or hospitalization due to PAH. Class I: No limitation of activity; Class II: slight limitation with ordinary activities; Class III: may not have symptoms at rest but greatly limited activities; Class IV: symptoms at rest and inability to carry out any physical activity without symptoms. Missing values were imputed using a LOCF approach.
Measured: Week 26
Change From Baseline to Week 26 in Mean Pulmonary Arterial Pressure (mPAP)
Change from baseline to Week 26 in mean Pulmonary Arterial Pressure (mPAP) was measured. The pulmonary artery pressure is a measure of the blood pressure found in the main pulmonary artery. Missing values were imputed using a LOCF approach.
Measured: Baseline, Week 26
Change From Baseline to Week 26 in Mean Right Atrial Pressure (mRAP)
Change from baseline to Week 26 in mean Right Atrial Pressure (mRAP) was measured. Missing values were imputed using a LOCF approach.
Measured: Baseline, Week 26
Change From Baseline to Week 26 in Total Pulmonary Resistance
Change from baseline to Week 26 in total pulmonary resistance was measured. Total pulmonary resistance was calculated as mPAP/CO*80, where CO is cardiac output. Re-calculated values were used for analysis and missing values were imputed using a LOCF approach.
Measured: Baseline, Week 26
Change From Baseline to Week 26 in Cardiac Index
Change from baseline to Week 26 in cardiac index was measured. Cardiac index is the amount of blood pumped by the heart, per minute, per meter square of body surface area. Re-calculated values were used for analysis and missing values were imputed using a LOCF approach.
Measured: Baseline, Week 26
Change From Baseline to Week 26 in Venous Oxygen Saturation (%)
Change from baseline to Week 26 in venous oxygen saturation was measured. Missing values were imputed using a LOCF approach.
Measured: Baseline, Week 26
Number of Participants With Disease Progression Event
Number of participants with disease progression event were reported. Disease progression event as adjudicated by the CEC, defined as any of the following: a. Death (all causes; adjudicated for PAH relationship); b. Hospitalization for worsening PAH; c. Initiation of prostacyclin, a prostacyclin analog, or a prostacyclin receptor agonist for worsening PAH; d. Clinical worsening defined as a post-baseline decrease in 6MWD by more than (>) 15 percent (%) from the highest 6MWD obtained at or after baseline, accompanied by WHO FC III or IV (both conditions confirmed at two consecutive post-baseline visits separated by 1-21 days).
Measured: Week 26, Month 12, Month 18, Month 24, Month 30, and End of Analysis Period (up to 40 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study start1 May 2016
- Primary completion29 Aug 2019
- Study completion20 Apr 2020
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558231
- Sponsor's protocol ID
- AC-065A308
- Acronym
- TRITON
- Status last verified
- Mar 2025
- First submitted
- 22 Sep 2015
- Last updated
- 30 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Chin KM, Sitbon O, Doelberg M, Feldman J, Gibbs JSR, Grunig E, Hoeper MM, Martin N, Mathai SC, McLaughlin VV, Perchenet L, Poch D, Saggar R, Simonneau G, Galie N. Three- Versus Two-Drug Therapy for Patients With Newly Diagnosed Pulmonary Arterial Hypertension. J Am Coll Cardiol. 2021 Oct 5;78(14):1393-1403. doi: 10.1016/j.jacc.2021.07.057.
PubMed 34593120
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension: A Multi-center, Double-blind, Placebo-controlled, Phase 3b Study
- ClinicalTrials.gov ID
- NCT02558231
- Acronym / sponsor ID
- TRITON / AC-065A308
- Conditions
- Pulmonary Arterial Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- 1 May 2016 (actual)
- Primary completion
- 29 Aug 2019 (actual)
- Study completion
- 20 Apr 2020 (actual)
- First posted
- 23 Sep 2015 (estimated)
- Results
- Posted 11 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this clinical trial is to compare the efficacy and safety of an initial triple oral treatment regimen (macitentan, tadalafil, selexipag) versus an initial dual oral treatment regimen (macitentan, tadalafil, placebo) in newly diagnosed, treatment-naïve patients with pulmonary arterial hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triple oral combination treatment | Experimental | Drug: Macitentan, Drug: Tadalafil, Drug: SelexipagMacitentan, tadalafil, and selexipag |
| Dual oral combination treatment | Placebo comparator | Drug: Macitentan, Drug: TadalafilMacitentan, tadalafil, and placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Signed informed consent prior to any study-mandated procedure.
- Male or female ≥ 18 and ≤ 75 years of age at screening.
- Initial PAH diagnosis < 6 months prior to enrollment.
- RHC performed between Day -28 and Day 1, meeting all the following criteria:
- Symptomatic PAH belonging to one of the following subgroups:
Key exclusion criteria (37 listed)
- Any PAH-specific drug therapy at any time.
- Cardio pulmonary rehabilitation program based on exercise (planned, or started ≤ 12 weeks prior to Day 1).
- Body mass index (BMI) > 40 kg/m2 at screening.
- Presence of three or more of the following risk factors for heart failure with preserved ejection fraction at screening:
- Acute myocardial infarction ≤ 12 weeks prior to screening.
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 |
|---|---|---|
| MacitentanUsed open-label in both arms, 10 mg tablet, 1 tablet u.i.d. | Drug | Dual oral combination treatment, Triple oral combination treatment |
| TadalafilUsed open-label in both arms, 20 mg tablet, 1-2 tablets u.i.d. | Drug | Dual oral combination treatment, Triple oral combination treatment |
| SelexipagUsed double-blind in the triple oral treatment arm, 200 microgram tablet, 1-8 tablets b.i.d. | Drug | Triple oral combination treatment |
Primary outcome
Change From Baseline to Week 26 in Pulmonary Vascular Resistance (PVR)
Time frame: Baseline, Week 26
Change from baseline to Week 26 in PVR was expressed as the ratio of Week 26 to baseline PVR value (Week 26 divided by baseline) using re-calculated PVR. PVR was determined by right heart catheterization (RHC). A geometric least square mean ratio of Week 26 to baseline PVR less than (<) 1 corresponds to a reduction in PVR from baseline. Missing values were imputed using a last observation carried forward (LOCF) approach.
9 secondary outcomes
Change From Baseline to Week 26 in 6-minute Walk Distance (6MWD)
Time frame: Baseline, Week 26
Change From Baseline to Week 26 in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) Levels
Time frame: Baseline, Week 26
Percentage of Participants With Absence of Worsening From Baseline to Week 26 in World Health Organization (WHO) Functional Class (FC)
Time frame: Week 26
Change From Baseline to Week 26 in Mean Pulmonary Arterial Pressure (mPAP)
Time frame: Baseline, Week 26
Change From Baseline to Week 26 in Mean Right Atrial Pressure (mRAP)
Time frame: Baseline, Week 26
Change From Baseline to Week 26 in Total Pulmonary Resistance
Time frame: Baseline, Week 26
Change From Baseline to Week 26 in Cardiac Index
Time frame: Baseline, Week 26
Change From Baseline to Week 26 in Venous Oxygen Saturation (%)
Time frame: Baseline, Week 26
Number of Participants With Disease Progression Event
Time frame: Week 26, Month 12, Month 18, Month 24, Month 30, and End of Analysis Period (up to 40 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34593120Chin KM, Sitbon O, Doelberg M, Feldman J, Gibbs JSR, Grunig E, Hoeper MM, Martin N, Mathai SC, McLaughlin VV, Perchenet L, Poch D, Saggar R, Simonneau G, Galie N. Three- Versus Two-Drug Therapy for Patients With Newly Diagnosed Pulmonary Arterial Hypertension. J Am Coll Cardiol. 2021 Oct 5;78(14):1393-1403. doi: 10.1016/j.jacc.2021.07.057.
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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.
58 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Macitentan, Tadalafil and Selexipag in people with Pulmonary Arterial Hypertension, run by Actelion at 58 sites in 15 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 15 inclusion and 37 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 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in United States, Canada, Germany, United Kingdom, Austria and 10 more countries. 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 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 11 Sep 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?
Change From Baseline to Week 26 in Pulmonary Vascular Resistance (PVR) (time frame: Baseline, Week 26). 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 NCT02558231, 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 30 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.