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One pill to rule them all? new combo therapy for PAH shows promise

NCT ID NCT03904693

Disease control Sponsor: Actelion Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a single pill containing two drugs (macitentan and tadalafil) works better than taking either drug alone for people with pulmonary arterial hypertension (PAH), a serious lung condition. 187 adults with PAH took either the combination pill or one of the single drugs for 16 weeks. The goal was to see if the combo improved blood flow in the lungs more effectively. This approach could make treatment easier by reducing the number of pills patients need to take.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
macitentan and tadalafil fixed-dose combination
What this could lead to
If successful, this single-pill combination could simplify treatment for PAH patients, potentially improving adherence and outcomes compared to taking separate pills.
What could go wrong
This is a completed Phase 3 trial, but results may not show a clear advantage over existing therapies. Side effects from either drug (e.g., headache, muscle pain) could still occur.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

187 people

The number who actually took part.

Started

Jul 2019

Finished

Sep 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Signed and dated informed consent form (ICF) * Confirmed diagnosis of symptomatic PAH in WHO FC II or III * Symptomatic PAH belonging to one of the following subgroups of WHO Group 1 pulmonary hypertension: * Idiopathic * Heritable * Drug- or toxin-induced * Associated with connective tissue disease, HIV infection, portal hypertension or congenital heart disease with simple systemic-to-pulmonary shunt with persistent pulmonary hypertension documented by a right heart catheterization (RHC) ≥ 1 year after surgical repair * PAH diagnosis confirmed by hemodynamic evaluation at rest (through central reading), evaluated within 5 weeks prior to randomization: * Mean pulmonary artery pressure (mPAP) ≥ 25 mmHg, AND * Pulmonary artery wedge pressure (PAWP) or left ventricular end diastolic pressure (LVEDP) ≤ 15 mmHg, AND * Pulmonary vascular resistance (PVR) ≥ 3 WU (i.e., ≥ 240 dyn∙sec∙cm-5) * Negative vasoreactivity test in idiopathic, heritable, and drug/toxin-induced PAH. (Participants for whom no vasoreactivity test was performed at diagnosis can be eligible if currently treated with PAH therapy for more than 3 months and PAH diagnosis confirmed by hemodynamic evaluation at least 3 months after introduction of their PAH therapy). * Currently receiving a stable dose of ERA or PDE-5i monotherapy for at least 3 months prior to baseline RHC, within the prespecified doses in the study protocol or no history of PAH-specific treatment * Participant able to perform the 6MWT with a minimum distance of 100 m and maximum distance of 450 m at Screening * A woman of childbearing potential must: * have negative serum pregnancy test at Screening and a negative urine pregnancy test at Randomization * agree to undertake monthly urine pregnancy tests during the study and up to at least 30 days after study treatment discontinuation * agree to follow the contraception scheme from Screening up to at least 30 days after study treatment discontinuation Exclusion Criteria: * Treatment with a soluble guanylate cyclase stimulator, L-arginine, any form of prostanoids or prostacyclin-receptor agonists (including oral, inhaled, or infused routes) in the 3-month period prior to start of treatment * Treatment with combination therapy of ERA and PDE-5i in the 3-month period prior to start of treatment or history of intolerance to ERA and PDE-5i combination therapy * Hypersensitivity to any of the study treatments or any excipient of their formulations * Treatment with a strong cytochrome P450 3A4 (CYP3A4) inducer in the 1-month period prior to start of treatment * Treatment with a strong CYP3A4 inhibitor or a moderate dual CYP3A4/CYP2C9 inhibitor or co-administration of a combination of moderate CYP3A4 and moderate CYP2C9 inhibitors in the 1-month period prior to start of treatment * Treatment with doxazosin * Treatment with any form of organic nitrate, either regularly or intermittently * Diuretic treatment initiated or dose changed within 1 week prior to the RHC or start of treatment * Treatment with another investigational drug in the 3-month period prior to start of treatment * Body mass index (BMI) \> 40 kg/m2 at Screening * Known 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 * Essential hypertension (even if well controlled) * Coronary artery disease, i.e. history of stable angina or known more than 50% stenosis in a coronary artery or history of myocardial infarction or history of or planned coronary artery bypass grafting and/or coronary artery stenting * Known presence of moderate or severe obstructive lung disease any time prior to Screening as specified in study protocol * Known presence of moderate or severe restrictive lung disease any time prior to Screening as specified in study protocol * Clinically significant aortic or mitral valve disease; pericardial constriction; restrictive or congestive left-sided cardiomyopathy; life-threatening cardiac arrhythmias; significant left ventricular dysfunction; or left ventricular outflow obstruction, in the opinion of the investigator * Known permanent atrial fibrillation, in the opinion of the investigator * Known or suspected uncontrolled thyroid disease (hypo- or hyperthyroidism) * Documented pulmonary veno-occlusive disease * Hemoglobin \< 100 g/L (\<10 g/dL) at Screening * Known severe hepatic impairment as specified in study protocol * Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 1.5 × upper limit of normal (ULN) at Screening * Severe renal impairment at Screening as specified in study protocol * Systemic hypotension at Screening or Randomization and systemic hypertension at Screening as specified in study protocol * Acute myocardial infarction or cerebrovascular event (e.g., stroke) within the last 26 weeks prior to Screening * Known bleeding disorder, in the opinion of the investigator * Loss of vision in one or both eyes because of non-arteritic anterior ischemic optic neuropathy * Hereditary degenerative retinal disorders, including retinitis pigmentosa * History of priapism, conditions that predispose to priapism (example, sickle cell anemia, multiple myeloma, or leukemia) or anatomical deformation of the penis (example, angulation, cavernosal fibrosis, or Peyronie's disease) * Difficulty swallowing large pills/tablets that would interfere with the ability to comply with study treatment regimen * Any planned surgical intervention (including organ transplant) during the double-blind treatment period, except minor interventions * Exercise training program for cardiopulmonary rehabilitation in the 12-week period prior to start of treatment, or planned to be started during the double-blind period of the study * Pregnant, planning to become pregnant or lactating * Any known factor or disease that might interfere with treatment adherence, full participation in the study or interpretation of the results as judged by the investigator (e.g., drug or alcohol dependence etc.) * Known concomitant life-threatening disease with a life expectancy less than (\<) 12 months * Calcium channel blocker treatment initiated, or dose changed within 3 months prior to right heart catheterization (RHC) at screening

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Conditions

The condition(s) this trial relates to.

pulmonary arterial hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary arterial hypertension (PAH) (who group 1 PH)

Contacts and locations

Locations

  • Abdullah, IA

    Durban, 4001, South Africa

  • Alberta Health Services

    Calgary, Alberta, T1Y 6J4, Canada

  • Altay Regional Cardiological Dispensary

    Barnaul, 656055, Russia

  • Ankara University Medical Faculty

    Ankara, 6500, Turkey (Türkiye)

  • Azienda Ospedaliera San Gerardo

    Monza, 20090, Italy

  • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

    Bari, 70124, Italy

  • Baylor Scott White - Plano

    Plano, Texas, 75093, United States

  • Beijing Anzhen Hospital

    Beijing, 100029, China

  • Bursa Yuksek Ihtisas Training and Research Hospital

    Bursa, 16310, Turkey (Türkiye)

  • Cardiologia c/o Spedali Civili

    Brescia, 25123, Italy

  • Chang-Gung Memorial Hospital, LinKou Branch

    Taoyuan, 333, Taiwan

  • Chiba University Hospital

    Chiba, 260 8677, Japan

  • Core Research Group

    Milton, 4064, Australia

  • Cukurova University Medical Faculty

    Adana, 01790, Turkey (Türkiye)

  • Dokuz Eylul University Hospital

    Izmir, 35340, Turkey (Türkiye)

  • Dr Kalla

    Lenasia, 1820, South Africa

  • ECZ Otwock Klinika Kardiologii Klinika Krazenia Plucnego Chorob Zakrzepowo Zatorowych i Kardiologii

    Otwock, 05-400, Poland

  • Ege University School of Medicine

    Izmir, 35100, Turkey (Türkiye)

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • Fukushima Medical University Hospital

    Fukushima, 960 1295, Japan

  • Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)

    Botucatu, 18618-686, Brazil

  • GCM SUM I Oddzial Kardiologii

    Katowice, 40 635, Poland

  • GU Moscow Regional Research Clinical Institute n.a. M.F.Vla

    Moscva, 129090, Russia

  • General University Hospital II.department of Internal Medicine-cardiology and angiology

    Prague, 128 08, Czechia

  • Gottsegen György Országos Kardiológiai Intézet, Felnőtt kardiológiai osztály

    Budapest, 1096, Hungary

  • Gunma University Hospital

    Gunma, 371-0034, Japan

  • Hacettepe University Medical Faculty

    Ankara, 6100, Turkey (Türkiye)

  • Hokkaido University Hospital

    Sapporo, 060-8648, Japan

  • Hosp Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007, Spain

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040, Spain

  • Hosp Univ Vall D Hebron

    Barcelona, 8035, Spain

  • Hosp. Gral. Univ. Valencia

    Valencia, 46014, Spain

  • Hosp. Univ. La Paz

    Madrid, 28046, Spain

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39011, Spain

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034, Spain

  • Hosp. Virgen de La Salud

    Toledo, 45004, Spain

  • Hospital Das Clinicas Da Faculdade De Medicina Da USP

    São Paulo, 05403-000, Brazil

  • Hospital das Clinicas de Porto Alegre

    Porto Alegre, 90035-007, Brazil

  • IRCCS Policlinico San Matteo, Università degli studi di Pavi

    Pavia, 27100, Italy

  • Institut Jantung Negara (National Heart Institute)

    Kuala Lumpur, 50400, Malaysia

  • Instituto Nacional de Cardiologia Dr. Ignacio Chavez

    México, 14080, Mexico

  • Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa

    Belo Horizonte, 30441-070, Brazil

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90035-074, Brazil

  • Istanbul University - Cerrahpasa Cardiology Institution

    Istanbul, 34096, Turkey (Türkiye)

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34096, Turkey (Türkiye)

  • Jiangsu Province Hospital

    Nanjing, China

  • Juntendo University Hospital

    Tokyo, 113-8431, Japan

  • Kagoshima University Hospital

    Kagoshima, 890-8544, Japan

  • Kanazawa University Hospital

    Kanazawa, 920 8641, Japan

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 813, Taiwan

  • Kardiologische Praxis Papenburg

    Papenburg, 26871, Germany

  • Kartal Kosuyolu Yuksek Ihtisas Egitim Ve Arastirma Hastanesi

    Kartal Istanbul, 34865, Turkey (Türkiye)

  • Klinika Kardiologii Z Oddzialem Intensywnego Nadzoru Kardiologicznego UM W Bialymstoku

    Bialystok, 15 276, Poland

  • Klinikum Würzburg Mitte gGmbH Standort Missioklinik

    Würzburg, 97074, Germany

  • Kobe University Hospital

    Kobe, 650 0017, Japan

  • Konya Selcuk University Medical Faculty

    Konya, 42131, Turkey (Türkiye)

  • Kumamoto University Hospital

    Kumamoto, 860-8556, Japan

  • Kure Kyosai Hospital

    Hiroshima, 737-8505, Japan

  • Kurume University Hospital

    Kurume, 830-0011, Japan

  • Kyorin University Hospital

    Mitaka, 181-8611, Japan

  • Kyoto University Hospital

    Kyoto, 606 8507, Japan

  • Kyushu University Hospital

    Fukuoka, 812 8582, Japan

  • Legacy Hospital

    Portland, Oregon, 97210, United States

  • London Health Sciences Centre

    London, Ontario, N6A 5W9, Canada

  • Mackay Memorial Hospital

    Taipei, 10449, Taiwan

  • Marmara University Medical Faculty

    Istanbul, 34899, Turkey (Türkiye)

  • Medical College of Wisconsin Froedtert Hospital

    Milwaukee, Wisconsin, 53226, United States

  • Mersin University Medical Faculty

    Mersin, 33110, Turkey (Türkiye)

  • Mie University Hospital

    Tsu, 514 8507, Japan

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407, United States

  • Nagasaki University Hospital

    Nagasaki, 852-8501, Japan

  • National Cerebral and Cardiovascular Center

    Suita-Shi, 564-8565, Japan

  • National Cheng Kung University Hospital

    Tainan, 704, Taiwan

  • National Heart Hospital

    Sofia, 1309, Bulgaria

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192, Japan

  • National Medical Research Center of Cardiology of MoH of Russian Federation

    Moscow, 121552, Russia

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • National medical Research Center n.a. V.A.Almazov of MoH of Russian Federation

    Saint Petersburg, 197341, Russia

  • Norton Healthcare

    Louisville, Kentucky, 40202-1332, United States

  • OSF HealthCare Cardiovascular Institute

    Peoria, Illinois, 61614, United States

  • Oddzial Kardiologii Wojewodzki Szpital Specjalistyczny im W Bieganskiego

    Lodz, 91 347, Poland

  • Okayama University Hospital

    Okayama, 700 8558, Japan

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Ospedale San Francesco

    Nuoro, 08100, Italy

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pécs, 7624, Hungary

  • Piedmont Healthcare

    Atlanta, Georgia, 30309, United States

  • Pitt County Memorial Hospital d/b/a Vidant Medical Center

    Greenville, North Carolina, 27835, United States

  • Policlinico Umberto I

    Roma, 00161, Italy

  • Providence Medical Foundation

    Fullerton, California, 92835, United States

  • Pulmonary Arterial Hypertension Clinic

    Hobart, 7000, Australia

  • Royal Adelaide Hospital

    Adelaide, 5000, Australia

  • SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo

    São Paulo, 04024-002, Brazil

  • Samara Regional Clinical Cardiological Dispensary

    Samara, 443070, Russia

  • Sanford Health

    Fargo, North Dakota, 58122, United States

  • Sanford Health

    Sioux Falls, South Dakota, 57105, United States

  • Sapporo Medical University Hospital

    Sapporo, 060-8543, Japan

  • Sarawak Heart Center

    Kuching, 94300, Malaysia

  • Scientific and Research Institution of Cardiovascular Diseases Complex Problems

    Kemerovo, 650002, Russia

  • Secretaria da Saude do Estado do Ceara - Hospital Doutor Carlos Alberto Studart Gomes

    Fortaleza, 60840-285, Brazil

  • Semmelweis Egyetem,Pulmonológiai Klinika

    Budapest, 1083, Hungary

  • Shanghai Pulmonary Hospital

    Shanghai, 200433, China

  • Shinshu University Hospital

    Matsumoto, 390 8621, Japan

  • Sparrow Clinical Research Institute

    Lansing, Michigan, 48912, United States

  • St. Elizabeth Hospital Mercy Bon Secors

    Youngstown, Ohio, 44503, United States

  • Szegedi Tudomanyegyetem

    Szeged, 6725, Hungary

  • Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy, Klinika Kardiologii

    Bydgoszcz, 85-168, Poland

  • Taipei Veterans General Hospital

    Taipei, 112, Taiwan

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120, China

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, 710061, China

  • The General Hospital of Northern Theater Command

    Shenyang, 110000, China

  • The Second Xiangya Hospital of Central South Hospital

    Changsha, 410011, China

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514, United States

  • The University of Tokyo Hospital

    Bunkyō City, 113-8655, Japan

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • Thoraxklinik am Universitatsklinikum Heidelberg

    Heidelberg, 69126, Germany

  • Tianjin Medical University General Hospital

    Tianjin, 300052, China

  • Tohoku University Hospital

    Sendai, 980 8574, Japan

  • Tokai University Hospital

    Isehara, 259-1193, Japan

  • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

    Porto Alegre, 90610-000, Brazil

  • Unidad de Investigacion Clinica en Medicina S.C. (UDICEM)

    Monterrey, 64718, Mexico

  • Universidade Federal De Minas Gerais - Hospital das Clínicas

    Belo Horizonte, 30130-100, Brazil

  • Universidade Federal de Goias - Hospital das Clinicas da UFG

    Goiânia, 74605-020, Brazil

  • Universitaetsklinikum Giessen

    Giessen, 35392, Germany

  • Universitaetsklinikum Hamburg Eppendorf

    Hamburg, 20246, Germany

  • Universitaetsklinikum Regensburg

    Regensburg, 93053, Germany

  • Universitat Greifswald

    Greifswald, 17475, Germany

  • Universitatsklinikum Bonn

    Bonn, 53105, Germany

  • Universitatsklinikum Carl Gustav Carus Dresden

    Dresden, 01307, Germany

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566, Japan

  • University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD

    Sofia, 1750, Bulgaria

  • University of Alberta

    Edmonton, Alberta, T6G 2G3, Canada

  • University of Cincinnati

    Cincinnati, Ohio, 45267, United States

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Southern California

    Los Angeles, California, 90033, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University of Tsukuba Hospital

    Tsukuba, 305 8576, Japan

  • University of Wisconsin At Madison

    Madison, Wisconsin, 53792, United States

  • Uniwersytecki Szpital Kliniczny nr 2 PUM Klinika Kardiologii

    Szczecin, 70 111, Poland

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 214, Poland

  • VA Sierra Nevada Health Care System

    Reno, Nevada, 89509, United States

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9, Canada

  • WVU Health Sciences Center

    Morgantown, West Virginia, 26506, United States

  • Washington University School Of Medicine

    St Louis, Missouri, 63110, United States

  • WellStar Health System

    Marietta, Georgia, 30060, United States

  • Wojewodzki Szpital Specjalistyczny Oddzial Kardiologiczny

    Wroclaw, 51 124, Poland

  • Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ, Oddzial Kardiologii

    Lublin, 20-718, Poland

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