Hypertension, PulmonaryPhase 3PLATYPUSNCT05179876
A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option
A Phase 3 study testing Macitentan, Selexipag and Macitentan/Tadalafil FDC in people with Hypertension, Pulmonary, run by Actelion at 45 sites in 13 countries.
Trial summary
The purpose of the study is to enable participants with pulmonary hypertension (PH) currently treated with study intervention(s) in a clinical study (parent studies [NCT03422328, NCT03904693,NCT04565990, NCT02932410, NCT03492177, and NCT04175600]), to continue to benefit from the intervention after closure of the… Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Hypertension, Pulmonary
- What is being tested?
- Macitentan, Selexipag and Macitentan/Tadalafil FDC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 45 sitesin 13 countries
- Study dates
- 4 May 2022to 28 Sep 2033
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participant must sign an informed consent form (ICF) (or their legally designated representative must sign) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
- Participant treated with oral macitentan or selexipag or fixed dose combination (FDC) of macitentan 10 milligrams (mg) and tadalafil 40 mg at the end of a sponsor parent study and: a) the indication of the parent study is included in the intervention-specific appendices (ISA) (pulmonary arterial hypertension [PAH]; b) participant has completed the parent study; c) no alternative means of access to study intervention (or equivalent approved therapy) have been identified; d) participant may continue to benefit from treatment with the study intervention; e) Participant is at least 18 years old for macitentan/tadalafil FDC, and at least 2 years old for macitentan or selexipag
- A female participant of childbearing potential must: a) have a negative urine or serum pregnancy test prior to first intake of study intervention; b) agree to perform monthly urine pregnancy test up to the end of the safety follow-up period; c) If heterosexually active, agree to follow contraceptive methods until 30 days after the last intake of the study intervention. For pediatric female participants: It is the responsibility of the investigator to ensure appropriate counselling, including consultation with a specialist (if needed), to the participant and/or parent(s)/ legally designated representative (LDR)(s) on the acceptable method of contraception
Who cannot join
- General:
- Participants prematurely discontinued from the study intervention in their parent study
- Female participant being pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study
- Planned or current treatment with another investigational treatment
- Macitentan-specific:
- Known allergies, hypersensitivity, or intolerance to macitentan or its excipients
Show all 22Show fewer
- Hemoglobin less than (<) 80 grams per liter (g/L)
- Serum aspartate (AST) and/or alanine aminotransferases (ALT) greater than (>) 3* upper limit of normal (ULN)
- Known and documented severe hepatic impairment that is, Child-Pugh Class C. For participants with hepatic impairment, Child-Pugh Class (Child-Pugh score) should be fully assessed and documented in the source documents at screening
- Selexipag-specific:
- Known allergies, hypersensitivity, or intolerance to selexipag or its excipients
- Suspected or known pulmonary veno-occlusive disease (PVOD)
- Uncontrolled thyroid disease
- Severe coronary heart disease or unstable angina, myocardial infarction within the last 6 months, decompensated cardiac failure (if not under close medical supervision), severe arrhythmia, cerebrovascular events (for example, transient ischemic attack, stroke) within the last 3 months, or congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension (PH)
- Known and documented severe hepatic impairment that is, Child-Pugh Class C. For participants with hepatic impairment, Child-Pugh Class (Child-Pugh score) should be fully assessed and documented in the source documents at screening
- Children only: (a) Current suspicion of intussusception or ileus or gastrointestinal obstruction, per the investigator's judgment; (b) hemoglobin or hematocrit <75 percent (%) of the lower limit of normal range
- Macitentan/tadalafil FDC-specific:
- Known allergies, hypersensitivity, or intolerance to macitentan or tadalafil or their excipients
- Hemoglobin <80 g/L
- Serum aspartate (AST) and/or alanine aminotransferases (ALT) >3* ULN range
- Known and documented severe hepatic impairment that is, Child-Pugh Class C. For participants with hepatic impairment, Child-Pugh Class should be fully assessed and documented in the source documents at screening
- Severe renal impairment (estimated glomerular filtration rate [eGF]/creatinine clearance <30 milliliter per minute [mL/min])
Trial locations and contacts
45 sites in 13 countries. Contact the study team or a site near you to ask about taking part.
45 sites in 13 countries
Poland8 sites, 3 recruiting
- Recruiting
Klinika Kardiologii Z Oddzialem Intensywnego Nadzoru Kardiologicznego UM W Bialymstoku
Bialystok, 15 276
- Completed
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy, Klinika Kardiologii
Bydgoszcz, 85-168
- Recruiting
SPSK nr 7 SUM w Katowicach Gornoslaskie Centrum Medyczne im Prof Leszka Gieca
Katowice, 40 635
- Completed
Oddzial Kardiologii Wojewodzki Szpital Specjalistyczny im W Bieganskiego
Lodz, 91 347
- Completed
Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego SPZOZ
Lublin, 20 718
- Completed
SPSK2 PUM Klinika Kardiologii
Szczecin, 70 111
- Completed
Wojewodzki Szpital Specjalist Osrodek Badawczo Rozwojowy
Wroclaw, 51 124
- Recruiting
Wojewodzki Szpital Specjalistyczny we Wroclawiu
Wroclaw, 51 124
China7 sites, 7 recruiting
- Recruiting
Beijing Anzhen Hospital 1
Beijing, 100029
- Recruiting
Beijing Anzhen Hospital
Beijing, 100029
- Recruiting
The Second Xiangya Hospital of Central South Hospital
Changsha, 410011
- Recruiting
Jiangsu Province Hospital
Nanjing
- Recruiting
Qingdao Women and Children's Hospital
Qingdao, 266035
- Recruiting
Childrens Hospital of Shanghai
Shanghai, 200062
- Recruiting
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, 710061
South Korea7 sites, 6 recruiting
- Recruiting
Chungnam National University Hospital
Daejeon, 35015
- Recruiting
Gachon University Gil Medical Center
Incheon, 21565
- Recruiting
Seoul National University Hospital 1
Seoul, 03080
- Recruiting
Seoul National University Hospital
Seoul, 03080
- Recruiting
Asan Medical Center
Seoul, 05505
- Recruiting
Samsung Medical Center
Seoul, 06351
- Completed
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591
Russia5 sites, 2 recruiting
- Completed
Scientific and Research Institution of Cardiovascular Diseases Complex Problems
Kemerovo, 650002
- Recruiting
E.Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation
Novosibirsk, 630055
- Completed
Federal State Budgetary Institution
Saint Petersburg, 197341
- Completed
Institute of Cardiology of Tomsk National Research Medical Center of Rus Academy of Sciences
Tomsk, 634012
- Recruiting
Regional Clinical Hospital No1
Tyumen, 625000
Taiwan5 sites, 5 recruiting
- Recruiting
Kaohsiung Veterans General Hospital
Kaohsiung City, 813
- Recruiting
National Cheng Kung University Hospital
Tainan, 704
- Recruiting
National Taiwan University Hospital
Taipei, 100
- Recruiting
Taipei Veterans General Hospital
Taipei, 112
- Recruiting
Chang-Gung Memorial Hospital, LinKou Branch
Taoyuan, 333
Vietnam3 sites, 3 recruiting
- Recruiting
Hanoi Heart Hospital
Hanoi
- Recruiting
Hanoi Medical University Hospital
Hanoi
- Recruiting
Children's Hospital 1
Ho Chi Minh City
Belarus2 sites, 1 recruiting
- Recruiting
The Republican Scientific-Practical Center ''Cardiology''
Minsk, 220036
- Completed
Minsk Regional Clinical Hospital Of The Red Banner Of Labor
Minsk
South Africa2 sites, 1 recruiting
- Completed
Abdullah, IA
Durban, 4001
- Recruiting
Dr Kalla
Lenasia, 1820
Ukraine2 sites
- Completed
Municipal Inst. Of Dnipropetrovsk Region. Council
Dnipro
- Completed
State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine
Kyiv, 03680
Bulgaria1 site, 1 recruiting
- Recruiting
University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD
Sofia, 1750
Hungary1 site, 1 recruiting
- Recruiting
Gottsegen György Országos Kardiológiai Intézet
Budapest, 1096
Thailand1 site, 1 recruiting
- Recruiting
Maharaj Nakorn Chiang Mai hospital Faculty of Medicine
Chiang Mai, 50200
About this study
Official title: A Prospective, Open-label, Platform Study for Long-term Follow-up of Participants Using Study Intervention in Pulmonary Hypertension Parent Studies
The purpose of the study is to enable participants with pulmonary hypertension (PH) currently treated with study intervention(s) in a clinical study (parent studies [NCT03422328, NCT03904693,NCT04565990, NCT02932410, NCT03492177, and NCT04175600]), to continue to benefit from the intervention after closure of the parent study in case they have no alternative means of access to the study intervention. This study will allow assessment of the long-term safety of each study intervention.
- Conditions
- Hypertension, Pulmonary
- Being tested
- Macitentan, Selexipag, Macitentan/Tadalafil FDC
- Keywords
- Chronic thromboembolic pulmonary hypertension (CTEPH), pulmonary arterial hypertension (PAH)
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MacitentanDrug
Also called JNJ-67896062
Adult participants will receive oral dose of macitentan 10 milligrams (mg) tablet once daily. Children greater than or equal to (>=) 2 year to less than (<) 18 years will be given an oral macitentan dose tailored to their body weight, ensuring an equivalent level of systemic exposure as in adults.
SelexipagDrug
Also called JNJ-67896049
Adult Participant will receive oral dose of selexipag tablet twice daily at the dose strength corresponding to their maintenance dose at the end of their parent study. Available strengths: 200, 400, 600, 800, 1000, 1200, 1400 and 1600 micrograms (µg). Children with body weight category of >=50 kg will use the tablets at the required dose strength as described for adults. Children with a body weight < 50 kg will receive tablets for pediatric use (dose strengths: 100 and 150 mcg), twice daily to enable continuation of individually maximum tolerated dose of selexipag according to their body weight category.
Macitentan/Tadalafil FDCDrug
Also called JNJ-68150420
Participants will receive oral FDC of macitentan 10 mg and tadalafil 40 mg once daily during the course of the study as already received in the parent studies.
| Study group | Role | What they receive |
|---|---|---|
| Macitentan | Experimental | Participants who have completed a parent study, benefit from their study intervention maintenance and have no adequate alternative local treatment option will be enrolled in this study and will continue to receive study drug macitentan orally during the course of the study. For adult participants study visits will be scheduled every 6 months and for pediatric participants study visits will be scheduled every 3 months. The study includes on-site visits to collect efficacy and safety information until participant discontinuation/withdrawal, or the respective study intervention is made commercially available in the country/territory or an equivalent approved therapy becomes available, or the sponsor decides to terminate the study prematurely. Receives: Drug: Macitentan |
| Selexipag | Experimental | Participants who have completed a parent study, benefit from their study intervention maintenance and have no adequate alternative local treatment option will be enrolled in this study and will continue to receive study drug selexipag orally during the course of the study. Study visits are scheduled every 6 months to collect efficacy and safety information until participant discontinuation/withdrawal, or the respective study intervention is made commercially available in the country/territory or an equivalent approved therapy becomes available, or the sponsor decides to terminate the study prematurely. Receives: Drug: Selexipag |
| Macitentan/Tadalafil FDC | Experimental | Participants who have completed a parent study, benefit from their study intervention maintenance and have no adequate alternative local treatment option will be enrolled in this study and will continue to receive drug Macitentan and Tadalafil fixed dose combination (FDC) orally during the course of the study. Study visits are scheduled every 6 months to collect efficacy and safety information until participant discontinuation/withdrawal, or the respective study intervention is made commercially available in the country/territory or an equivalent approved therapy becomes available, or the sponsor decides to terminate the study prematurely. Receives: Drug: Macitentan/Tadalafil FDC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs are defined as a treatment-emergent AE is any AE temporally associated with the use of study treatment (from start of treatment in the PLATYPUS protocol until 30 days after study treatment discontinuation) whether or not considered by the investigator as related to study treatment.
Measured: Baseline until End of Study (EOS) (up to 84 months)
Frequency of TEAEs Leading to Discontinuation
Frequency of TEAEs leading to discontinuation of study intervention will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs are defined as a treatment-emergent AE is any AE temporally associated with the use of study treatment (from start of treatment in the PLATYPUS protocol until 30 days after study treatment discontinuation) whether or not considered by the investigator as related to study treatment.
Measured: Baseline until EOS (up to 84 months)
Frequency of Serious Adverse Events (SAEs)
SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product and is medically important.
Measured: Baseline until EOS (up to 84 months)
Frequency of Deaths
Frequency of deaths will be reported.
Measured: Baseline until EOS (up to 84 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start4 May 2022
- Primary completion31 Jan 2027 (estimated)
- Study completion28 Sep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, PulmonaryStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, open-label, extension study, with a platform-study design for long-term safety follow-up of participants using study intervention as in their respective pulmonary hypertension (PH) parent study (that is, pulmonary arterial hypertension \[PAH\] or chronic thromboembolic pulmonary hypertension \[CTEPH\]). Participants who have completed a parent study, that benefit from their study intervention maintenance and have no adequate alternative local treatment option (access to the study intervention or an equivalent approved therapy) will be enrolled in this study.
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Actelion Pharmaceuticals Ltd Clinical Trial, Study director, Actelion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179876
- Sponsor's protocol ID
- CR109121
- Other IDs
- NOPRODPAPUH3001, 2021-002297-11, 2023-506791-27-00, 2023
- Acronym
- PLATYPUS
- Status last verified
- Nov 2026
- First submitted
- 17 Dec 2021
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Platform Study for Long-term Follow-up of Participants Using Study Intervention in Pulmonary Hypertension Parent Studies
- ClinicalTrials.gov ID
- NCT05179876
- Acronym / sponsor ID
- PLATYPUS / CR109121
- Conditions
- Hypertension, Pulmonary
- Keywords
- Chronic thromboembolic pulmonary hypertension (CTEPH), pulmonary arterial hypertension (PAH)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- 4 May 2022 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 28 Sep 2033 (estimated)
- First posted
- 5 Jan 2022 (actual)
- 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 purpose of the study is to enable participants with pulmonary hypertension (PH) currently treated with study intervention(s) in a clinical study (parent studies [NCT03422328, NCT03904693,NCT04565990, NCT02932410, NCT03492177, and NCT04175600]), to continue to benefit from the intervention after closure of the parent study in case they have no alternative means of access to the study intervention. This study will allow assessment of the long-term safety of each study intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a prospective, open-label, extension study, with a platform-study design for long-term safety follow-up of participants using study intervention as in their respective pulmonary hypertension (PH) parent study (that is, pulmonary arterial hypertension [PAH] or chronic thromboembolic pulmonary hypertension [CTEPH]). Participants who have completed a parent study, that benefit from their study intervention maintenance and have no adequate alternative local treatment option (access to the study intervention or an equivalent approved therapy) will be enrolled in this study.
| Arm | Type | Receives |
|---|---|---|
| Macitentan | Experimental | Drug: MacitentanParticipants who have completed a parent study, benefit from their study intervention maintenance and have no adequate alternative local treatment option will be enrolled in this study and will continue to receive study drug macitentan orally during the course of the study. For adult participants study visits will be scheduled every 6 months and for pediatric participants study visits will be scheduled every 3 months. The study includes on-site visits to collect efficacy and safety information until participant discontinuation/withdrawal, or the respective study intervention is made commercially available in the country/territory or an equivalent approved therapy becomes available, or the sponsor decides to terminate the study prematurely. |
| Selexipag | Experimental | Drug: SelexipagParticipants who have completed a parent study, benefit from their study intervention maintenance and have no adequate alternative local treatment option will be enrolled in this study and will continue to receive study drug selexipag orally during the course of the study. Study visits are scheduled every 6 months to collect efficacy and safety information until participant discontinuation/withdrawal, or the respective study intervention is made commercially available in the country/territory or an equivalent approved therapy becomes available, or the sponsor decides to terminate the study prematurely. |
| Macitentan/Tadalafil FDC | Experimental | Drug: Macitentan/Tadalafil FDCParticipants who have completed a parent study, benefit from their study intervention maintenance and have no adequate alternative local treatment option will be enrolled in this study and will continue to receive drug Macitentan and Tadalafil fixed dose combination (FDC) orally during the course of the study. Study visits are scheduled every 6 months to collect efficacy and safety information until participant discontinuation/withdrawal, or the respective study intervention is made commercially available in the country/territory or an equivalent approved therapy becomes available, or the sponsor decides to terminate the study prematurely. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Participant must sign an informed consent form (ICF) (or their legally designated representative must sign) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
- Participant treated with oral macitentan or selexipag or fixed dose combination (FDC) of macitentan 10 milligrams (mg) and tadalafil 40 mg at the end of a sponsor parent study and: a) the indication of the parent study is included in the intervention-specific appendices (ISA) (pulmonary arterial hypertension [PAH]; b) participant has completed the parent study; c) no alternative means of access to study intervention (or equivalent approved therapy) have been identified; d) participant may continue to benefit from treatment with the study intervention; e) Participant is at least 18 years old for macitentan/tadalafil FDC, and at least 2 years old for macitentan or selexipag
- A female participant of childbearing potential must: a) have a negative urine or serum pregnancy test prior to first intake of study intervention; b) agree to perform monthly urine pregnancy test up to the end of the safety follow-up period; c) If heterosexually active, agree to follow contraceptive methods until 30 days after the last intake of the study intervention. For pediatric female participants: It is the responsibility of the investigator to ensure appropriate counselling, including consultation with a specialist (if needed), to the participant and/or parent(s)/ legally designated representative (LDR)(s) on the acceptable method of contraception
Key exclusion criteria (22 listed)
- Participants prematurely discontinued from the study intervention in their parent study
- Female participant being pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study
- Planned or current treatment with another investigational treatment
- Known allergies, hypersensitivity, or intolerance to macitentan or its excipients
- Hemoglobin less than (<) 80 grams per liter (g/L)
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 |
|---|---|---|
| MacitentanAlso: JNJ-67896062Adult participants will receive oral dose of macitentan 10 milligrams (mg) tablet once daily. Children greater than or equal to (>=) 2 year to less than (<) 18 years will be given an oral macitentan dose tailored to their body weight, ensuring an equivalent level of systemic exposure as in adults. | Drug | Macitentan |
| SelexipagAlso: JNJ-67896049Adult Participant will receive oral dose of selexipag tablet twice daily at the dose strength corresponding to their maintenance dose at the end of their parent study. Available strengths: 200, 400, 600, 800, 1000, 1200, 1400 and 1600 micrograms (µg). Children with body weight category of >=50 kg will use the tablets at the required dose strength as described for adults. Children with a body weight < 50 kg will receive tablets for pediatric use (dose strengths: 100 and 150 mcg), twice daily to enable continuation of individually maximum tolerated dose of selexipag according to their body weight category. | Drug | Selexipag |
| Macitentan/Tadalafil FDCAlso: JNJ-68150420Participants will receive oral FDC of macitentan 10 mg and tadalafil 40 mg once daily during the course of the study as already received in the parent studies. | Drug | Macitentan/Tadalafil FDC |
Primary outcome
Frequency of Treatment Emergent Adverse Events (TEAEs)
Time frame: Baseline until End of Study (EOS) (up to 84 months)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs are defined as a treatment-emergent AE is any AE temporally associated with the use of study treatment (from start of treatment in the PLATYPUS protocol until 30 days after study treatment discontinuation) whether or not considered by the investigator as related to study treatment.
Frequency of TEAEs Leading to Discontinuation
Time frame: Baseline until EOS (up to 84 months)
Frequency of TEAEs leading to discontinuation of study intervention will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs are defined as a treatment-emergent AE is any AE temporally associated with the use of study treatment (from start of treatment in the PLATYPUS protocol until 30 days after study treatment discontinuation) whether or not considered by the investigator as related to study treatment.
Frequency of Serious Adverse Events (SAEs)
Time frame: Baseline until EOS (up to 84 months)
SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product and is medically important.
Frequency of Deaths
Time frame: Baseline until EOS (up to 84 months)
Frequency of deaths will be reported.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes. The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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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.
Actelion Pharmaceuticals Ltd Clinical Trial study director
Actelion
45 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Macitentan, Selexipag and Macitentan/Tadalafil FDC in people with Hypertension, Pulmonary, run by Actelion at 45 sites in 13 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 3 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in Poland, China, South Korea, Russia, Taiwan and 8 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Treatment Emergent Adverse Events (TEAEs) (time frame: Baseline until End of Study (EOS) (up to 84 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.