Pulmonary HypertensionPhase 2SOPRANONCT02554903
Clinical Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation
A Phase 2 study testing Macitentan 10mg in people with Pulmonary Hypertension, run by Actelion at 50 sites in United States.
Trial summary
STUDY OBJECTIVES Primary objective To evaluate the effect of macitentan 10 mg on pulmonary vascular resistance (PVR) as compared to placebo in subjects with pulmonary hypertension (PH) after left ventricular assist device (LVAD) implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Macitentan 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 50 sitesUnited States
- Study dates
- 28 Mar 2016to 13 Mar 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written Informed Consent prior to initiation of any study-mandated procedure.
- Males or females ≥ 18 years of age.
- Surgical implantation of LVAD within 90 days prior to Randomization.
- Hemodynamic evidence of PH on Baseline right heart catheterization (RHC) by the thermodilution method. Baseline RHC is defined as the last hemodynamic measurements after LVAD implantation and prior to the first dose of study treatment. PH is defined as:
- Mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg and
- Pulmonary artery wedge pressure (PAWP) ≤ 18 mmHg and
Show all 17Show fewer
- PVR > 3 Wood units.
- Stabilization of the patient for 48 h prior to the Baseline RHC, defined as:
- No LVAD pump speed/flow rate changes and
- Stable dose of oral diuretics and
- No intravenous (i.v.) inotropes or vasopressors and
- Patient able to ambulate.
- A woman of childbearing potential is eligible only if she has:
- A negative serum pregnancy test result during the Screening period (Visit 1) and Randomization (Visit 2) and
- Agreement to undertake monthly serum pregnancy tests during the study and up to 30 days after study treatment discontinuation and
- Agreement to use one of the methods of contraception / follow the contraception scheme described in Section 4.5 from Screening and up to at least 30 days after study treatment discontinuation.
- Patient must be randomized within 14 days of Baseline RHC.
Who cannot join
- Documented severe obstructive lung disease defined as: forced expiratory volume in 1 second / forced vital capacity (FEV1/FVC) < 0.7 associated with FEV1 < 50% of predicted value after bronchodilator administration.
- Documented moderate to severe restrictive lung disease defined as: total lung capacity < 60% of predicted value.
- Documented pulmonary veno-occlusive disease.
- Patients undergoing dialysis.
- Hemoglobin < 8.5 g/dL at Randomization.
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 × the upper limit of normal (ULN) at Randomization.
Show all 19Show fewer
- Severe hepatic impairment, e.g., Child-Pugh Class C liver disease.
- Body weight < 40 kg at Randomization.
- Doppler mean blood pressure < 65 mmHg at Randomization.
- GFR < 30 mL/min at Randomization.
- Pregnant, planning to become pregnant during the study period, or breastfeeding.
- Treatment with endothelin receptor antagonists (ERAs), phosphodiesterase-5 (PDE5) inhibitors, i.v., subcutaneous (s.c.), or oral prostanoids, or guanylate cyclase stimulators within 7 days prior to Baseline RHC or study treatment initiation.
- Treatment with inhaled prostanoids (e.g., iloprost, epoprostenol) or nitric oxide within 24 h prior to Baseline RHC or study treatment initiation.
- Treatment with strong inducers of cytochrome P450 isozyme 3A4 (CYP3A4) within 28 days prior to study treatment initiation (e.g., carbamazepine, rifampicin, rifabutin, phenytoin and St. John's Wort).
- Treatment with strong inhibitors of CYP3A4 within 28 days prior to study treatment initiation (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, nefazodone, ritonavir, saquinavir, boceprevir, telaprevir, iopinavir, fosamprenavir, darunavir, tipranavir, atazanavir, nelfinavir, amprenavir, and idinavir).
- Treatment with another investigational drug (planned, or taken) within 28 days prior to study treatment initiation.
- Known hypersensitivity to ERAs, or to any of the study treatment excipients.
- Any condition that prevents compliance with the protocol or adherence to therapy.
- Known concomitant life-threatening disease with a life expectancy < 12 months.
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
United States50 sites
#149_Seton Heart Institute
Austin, Texas, 78705
#129_John Hopkins University Medical Center
Baltimore, Maryland, 21287
#106_Cedars-Sinai Medical Center
Beverly Hills, California, 90211
#143_Tufts Medical Center
Boston, Massachusetts, 02111
#138_Massachusetts General Hospital
Boston, Massachusetts, 02114
#119_Brigham and Women's Hospital
Boston, Massachusetts, 02115
Medical University of South Carolina
Charleston, South Carolina, 29425
#114_University of Virginia
Charlottesville, Virginia, 22905
#135_University of Chicago Medical Center
Chicago, Illinois, 60637
#148_University of Cincinnati Medical Center
Cincinnati, Ohio, 45242
#153_Cleveland Clinic
Cleveland, Ohio, 44195
#141_Palmetto Health / Palmetto Heart
Columbia, South Carolina, 29203
#101_The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
#136_Baylor Health - Baylor University Medical Center
Dallas, Texas, 75226
#115_Henry Ford Hospital
Detroit, Michigan, 48202
#111_Inova Fairfax Hospital
Falls Church, Virginia, 22042
#142_Penn State Heart and Vascular Institute
Hershey, Pennsylvania, 17033
#107_Houston Methodist Hospital
Houston, Texas, 77030
#108_Indiana University Health Physicians Cardiology
Indianapolis, Indiana, 46202
#112_St. Vincent Medical Group, Inc
Indianapolis, Indiana, 46260
#120_University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
#150_Saint Luke's Hospital
Kansas City, Missouri, 64111
#154_University of California San Diego
La Jolla, California, 92037
#117_University of Louisville
Louisville, Kentucky, 40202
#155_University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
#151_Stern Cardiovascular Foundation
Memphis, Tennessee, 38120
#146_Vanderbilt University Medical Center
Nashville, Tennessee, 37232
#105_Ochsner Medical Center
New Orleans, Louisiana, 70121
#103_Weill Cornell Medical College
New York, New York, 10021
#139_Icahn School of Medicine at Mount Sinai
New York, New York, 94080
#113_Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
#121_Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112
#131_University of Nebraska Medical Center
Omaha, Nebraska, 68918
#126_Florida Hospital
Orlando, Florida, 32804
#140_Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
#125_Mayo Clinic Arizona
Phoenix, Arizona, 85054
#134_Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
#130_University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
#116_Virginia Commonwealth University (VCU) Medical Center
Richmond, Virginia, 23298
#102_Mayo Clinic
Rochester, Minnesota, 55905
#110_Sutter Heart Institute
Sacramento, California, 95819
#127_The University of Utah
Salt Lake City, Utah, 84112
#122_Advanced Heart Failure Clinic - HCM
San Antonio, Texas, 78229
#132_University of California San Francisco
San Francisco, California, 94143
#104_Washington University School of Medicine
St Louis, Missouri, 63110
#133_Montefiore Medical Center
The Bronx, New York, 10467
#145_The University of Toledo Medical Center
Toledo, Ohio, 43614
#144_University of Arizona
Tucson, Arizona, 85724
#147_Westchester Medical Center
Valhalla, New York, 10595
#123_MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: A Prospective, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation
STUDY OBJECTIVES Primary objective To evaluate the effect of macitentan 10 mg on pulmonary vascular resistance (PVR) as compared to placebo in subjects with pulmonary hypertension (PH) after left ventricular assist device (LVAD) implantation.
Secondary objectives To evaluate the effect of macitentan 10 mg as compared to placebo on cardio-pulmonary hemodynamics and disease severity in subjects with PH after LVAD implantation.
Read more
To evaluate the safety and tolerability of macitentan 10 mg in subjects with PH after LVAD implantation.
Exploratory objectives To explore the potential effect of macitentan 10 mg as compared to placebo on right ventricular function in subjects with PH after LVAD implantation.
To explore the potential effect of macitentan 10 mg as compared to placebo on selected clinical events in subjects with PH after LVAD implantation.
To explore the potential effect of macitentan 10 mg as compared to placebo on renal function as measured by glomerular filtration rate (GFR) in subjects with PH after LVAD implantation.
- Conditions
- Pulmonary Hypertension
- Being tested
- Macitentan 10mg, Placebo sugar pill
- Keywords
- LVAD
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macitentan 10mgDrug
Also called Active drug
2 groups, randomized in a 1:1 ratio by an Interactive Voice/Web Randomization System to macitentan 10 mg or placebo
Placebo sugar pillDrug
Also called placebo comparator
2 groups, randomized in a 1:1 ratio by an Interactive Voice/Web Randomization System to macitentan 10 mg or placebo
| Study group | Role | What they receive |
|---|---|---|
| Macitentan 10 mg po | Experimental | Approximately 78 adult subjects with PH post-LVAD implantation will be randomized (1:1) to receive either macitentan 10 mg, or matching placebo, once daily orally. Receives: Drug: Macitentan 10mg |
| Placebo sugar pill | Placebo comparator | Approximately 78 adult subjects with PH post-LVAD implantation will be randomized (1:1) to receive either macitentan 10 mg, or matching placebo, once daily orally. Receives: Drug: Placebo sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Vascular Resistance (PVR) Ratio of Week 12 to Baseline
PVR ratio equals to Week 12 PVR / Baseline PVR. PVR represents the resistance against which the right ventricle needs to pump. PVR was calculated using the following formula: mean pulmonary arterial pressure (mPAP) - pulmonary artery wedge pressure (PAWP)/cardiac output (CO); where mPAP and PAWP were measured at end-expiration and CO was measured in triplicate using the thermodilution method.
Measured: Baseline to Week 12
Secondary outcomes (8)
Change From Baseline to Week 12 in Mean Right Atrial Pressure (mRAP)
mRAP was collected in the eCRF (electronic case record form). Right atrial pressure (RAP) is the blood pressure in the right atrium of the heart. Change from baseline to Week 12 in mRAP was measured at rest and no correction for multiple testing was applied.
Measured: Baseline to Week 12
Change From Baseline to Week 12 in Mean Pulmonary Arterial Pressure (mPAP)
mPAP was collected in the eCRF. The pulmonary artery pressure is a measure of the blood pressure found in the main pulmonary artery. Change from baseline to Week 12 in mPAP was measured at rest and no correction for multiple testing was applied.
Measured: Baseline to Week 12
Change From Baseline to Week 12 in Pulmonary Arterial Wedge Pressure (PAWP)
PAWP was collected in the eCRF. PAWP is pressure within the pulmonary arterial system when the catheter tip is 'wedged' in the tapering branch of one of the pulmonary arteries. Change from baseline to Week 12 in PAWP was measured at rest and no correction for multiple testing was applied.
Measured: Baseline to Week 12
Change From Baseline to Week 12 in Cardiac Index (CI)
CI was calculated as Cardiac Output (CO)/body surface area (BSA), where CO is Thermodilution Cardiac Output (Liters per minute [L/min]) and BSA (m^2) equals to 0.007184*weight^0.425 (kilograms)*height^0.725 (centimeter). CI was represented in liters per minute per square meter (L/min/m^2). Change from baseline to Week 12 in CI was measured at rest and no correction for multiple testing was applied.
Measured: Baseline to Week 12
Change From Baseline to Week 12 in Total Pulmonary Resistance (TPR)
TPR was calculated as mPAP/CO where mPAP is mean pulmonary arterial pressure and CO is cardiac output. Change from baseline to Week 12 in TPR was calculated at rest and no correction for multiple testing was applied.
Measured: Baseline to Week 12
Change From Baseline to Week 12 in Mixed Venous Oxygen Saturation (SvO2)
Mixed venous oxygen saturation measures the end result of oxygen consumption and delivery. Change from baseline to Week 12 in SvO2 was reported and measured at rest and no correction for multiple testing was applied.
Measured: Baseline to Week 12
Change From Baseline to Week 12 in N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) Levels
NT-proBNP levels in the blood are used for diagnosis of acute congestive heart failure (CHF) and may be useful to establish prognosis in heart failure.
Measured: Baseline to Week 12
Change From Baseline to Week 12 in Participants World Health Organization (WHO) Functional Class (FC)
WHO FC is a classification which reflects disease severity based on symptoms. WHO Functional Classification of pulmonary hypertension comprises of Class I (participants with pulmonary hypertension but without resulting limitation of physical activity), II (participants with pulmonary hypertension resulting in slight limitation of physical activity), III (participants with pulmonary hypertension resulting in marked limitation of physical activity) and IV (participants with pulmonary hypertension with inability to carry out any physical activity without symptoms). Change from baseline in WHO FC was reported. WHO FC was categorized as worsening (change greater than [>] 0); improvement (change less than [<] 0); or no change (change equals to [=] 0).
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study start28 Mar 2016
- Primary completion13 Mar 2020
- Study completion13 Mar 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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Rocco, Study director, Actelion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554903
- Sponsor's protocol ID
- AC-055-205
- Acronym
- SOPRANO
- Status last verified
- Mar 2025
- First submitted
- 8 Sep 2015
- Last updated
- 30 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Frantz RP, Desai SS, Ewald G, Franco V, Hage A, Horn EM, LaRue SJ, Mathier MA, Mandras S, Park MH, Ravichandran AK, Schilling JD, Wang IW, Zolty R, Rendon GG, Rocco MA, Selej M, Zhao C, Rame JE. SOPRANO: Macitentan in patients with pulmonary hypertension following left ventricular assist device implantation. Pulm Circ. 2024 Dec 4;14(4):e12446. doi: 10.1002/pul2.12446. eCollection 2024 Oct.
PubMed 39635465
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
- A Prospective, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation
- ClinicalTrials.gov ID
- NCT02554903
- Acronym / sponsor ID
- SOPRANO / AC-055-205
- Conditions
- Pulmonary Hypertension
- Keywords
- LVAD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2016 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 18 Sep 2015 (estimated)
- Results
- Posted 1 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
STUDY OBJECTIVES Primary objective To evaluate the effect of macitentan 10 mg on pulmonary vascular resistance (PVR) as compared to placebo in subjects with pulmonary hypertension (PH) after left ventricular assist device (LVAD) implantation.
Secondary objectives To evaluate the effect of macitentan 10 mg as compared to placebo on cardio-pulmonary hemodynamics and disease severity in subjects with PH after LVAD implantation.
To evaluate the safety and tolerability of macitentan 10 mg in subjects with PH after LVAD implantation.
Exploratory objectives To explore the potential effect of macitentan 10 mg as compared to placebo on right ventricular function in subjects with PH after LVAD implantation.
To explore the potential effect of macitentan 10 mg as compared to placebo on selected clinical events in subjects with PH after LVAD implantation.
To explore the potential effect of macitentan 10 mg as compared to placebo on renal function as measured by glomerular filtration rate (GFR) in subjects with PH after LVAD implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Macitentan 10 mg po | Experimental | Drug: Macitentan 10mgApproximately 78 adult subjects with PH post-LVAD implantation will be randomized (1:1) to receive either macitentan 10 mg, or matching placebo, once daily orally. |
| Placebo sugar pill | Placebo comparator | Drug: Placebo sugar pillApproximately 78 adult subjects with PH post-LVAD implantation will be randomized (1:1) to receive either macitentan 10 mg, or matching placebo, once daily orally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Written Informed Consent prior to initiation of any study-mandated procedure.
- Males or females ≥ 18 years of age.
- Surgical implantation of LVAD within 90 days prior to Randomization.
- Hemodynamic evidence of PH on Baseline right heart catheterization (RHC) by the thermodilution method. Baseline RHC is defined as the last hemodynamic measurements after LVAD implantation and prior to the first dose of study treatment. PH is defined as:
- Stabilization of the patient for 48 h prior to the Baseline RHC, defined as:
Key exclusion criteria (19 listed)
- Documented severe obstructive lung disease defined as: forced expiratory volume in 1 second / forced vital capacity (FEV1/FVC) < 0.7 associated with FEV1 < 50% of predicted value after bronchodilator administration.
- Documented moderate to severe restrictive lung disease defined as: total lung capacity < 60% of predicted value.
- Documented pulmonary veno-occlusive disease.
- Patients undergoing dialysis.
- Hemoglobin < 8.5 g/dL at Randomization.
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 |
|---|---|---|
| Macitentan 10mgAlso: Active drug2 groups, randomized in a 1:1 ratio by an Interactive Voice/Web Randomization System to macitentan 10 mg or placebo | Drug | Macitentan 10 mg po |
| Placebo sugar pillAlso: placebo comparator2 groups, randomized in a 1:1 ratio by an Interactive Voice/Web Randomization System to macitentan 10 mg or placebo | Drug | Placebo sugar pill |
Primary outcome
Pulmonary Vascular Resistance (PVR) Ratio of Week 12 to Baseline
Time frame: Baseline to Week 12
PVR ratio equals to Week 12 PVR / Baseline PVR. PVR represents the resistance against which the right ventricle needs to pump. PVR was calculated using the following formula: mean pulmonary arterial pressure (mPAP) - pulmonary artery wedge pressure (PAWP)/cardiac output (CO); where mPAP and PAWP were measured at end-expiration and CO was measured in triplicate using the thermodilution method.
8 secondary outcomes
Change From Baseline to Week 12 in Mean Right Atrial Pressure (mRAP)
Time frame: Baseline to Week 12
Change From Baseline to Week 12 in Mean Pulmonary Arterial Pressure (mPAP)
Time frame: Baseline to Week 12
Change From Baseline to Week 12 in Pulmonary Arterial Wedge Pressure (PAWP)
Time frame: Baseline to Week 12
Change From Baseline to Week 12 in Cardiac Index (CI)
Time frame: Baseline to Week 12
Change From Baseline to Week 12 in Total Pulmonary Resistance (TPR)
Time frame: Baseline to Week 12
Change From Baseline to Week 12 in Mixed Venous Oxygen Saturation (SvO2)
Time frame: Baseline to Week 12
Change From Baseline to Week 12 in N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) Levels
Time frame: Baseline to Week 12
Change From Baseline to Week 12 in Participants World Health Organization (WHO) Functional Class (FC)
Time frame: Baseline to Week 12
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 39635465Frantz RP, Desai SS, Ewald G, Franco V, Hage A, Horn EM, LaRue SJ, Mathier MA, Mandras S, Park MH, Ravichandran AK, Schilling JD, Wang IW, Zolty R, Rendon GG, Rocco MA, Selej M, Zhao C, Rame JE. SOPRANO: Macitentan in patients with pulmonary hypertension following left ventricular assist device implantation. Pulm Circ. 2024 Dec 4;14(4):e12446. doi: 10.1002/pul2.12446. eCollection 2024 Oct.
- Individual participant dataSharing planned: Undecided
Related trials for Pulmonary 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)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
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.
Mark Rocco study director
Actelion
50 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Macitentan 10mg in people with Pulmonary Hypertension, run by Actelion at 50 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 17 inclusion and 19 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 50 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2021). 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?
Pulmonary Vascular Resistance (PVR) Ratio of Week 12 to Baseline (time frame: Baseline to Week 12). 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 NCT02554903, 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.