Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)

NCT ID: NCT03904693

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 187 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-29
• Study Completion Date: 2024-09-27

Brief Summary

Combination therapy in pulmonary arterial hypertension (PAH) has been the subject of active investigation for more than a decade, with the benefit of targeting different pathways known to be involved in the pathogenesis of the disease. Adherence to prescribed therapy has an impact on clinical outcomes. Reducing the pill/tablet count and frequency has a major impact on patients' adherence to therapies and therefore the observed clinical outcomes. One way to simplify treatment is to use fixed-dose combination (FDC) products that combine multiple treatments targeting different pathways into a single tablet.

This study aims to demonstrate that the FDC of macitentan and tadalafil is more effective than therapy with 10 mg of macitentan alone or 40 mg of tadalafil alone. This phase 3 study will evaluate the efficacy and safety at 16 weeks of an FDC (macitentan 10 mg and tadalafil 40 mg) against these two PAH-approved therapies given as monotherapy to further confirm the added value of the FDC.

Detailed Description

PAH is characterized by a progressive increase in pulmonary arterial pressure (PAP) and in pulmonary vascular resistance (PVR) potentially leading to right heart failure and death. Current PAH-specific therapeutic options include treatments that target the three pathways (endothelin, nitric oxide, and prostacyclin pathways). While combination treatment is common, FDC pills or tablets that combine two or more PAH-specific therapies are not available, thereby requiring participants to take multiple pills/tablets daily. An FDC is an attractive option for PAH participants because it simplifies the treatment regimen by combining two therapies (which would otherwise involve a total of three tablets: one macitentan 10 mg tablet and two tadalafil 20 mg tablets) into a single tablet. Macitentan is an orally active, non-peptide, potent dual endothelin receptor A and B antagonist. Tadalafil is a selective inhibitor of phosphodiesterase type-5 (PDE-5), the enzyme responsible for the degradation of cyclic guanosine monophosphate (cGMP). This study comprises the following consecutive periods: Screening period (lasts up to 30 days), Double-blind treatment period (consists of the titration phase [the first 2 weeks] and the maintenance phase [Week 3 through Week 16]), Open-label treatment period, End-of-Treatment (EOT), Safety follow-up (S-FU) period, and End of Study (EOS). The total study duration for a participant will be up to 30 months. Study assessments like physical examinations, vital signs, right heart catheterization, 6-minute walk test will be performed. Safety will be assessed throughout the study.

Conditions

Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)

Keywords

Pulmonary Arterial Hypertension; PAH; macitentan; tadalafil; fixed dose combination therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

FDC therapy + Placebo macitentan + Placebo tadalafil

Subjects to receive FDC macitentan/tadalafil (macitentan 10 mg and tadalafil 40 mg) plus matching placebos for the two other study treatments.

Group Type: EXPERIMENTAL

FDC macitentan/tadalafil

Intervention Type: DRUG

Film-coated tablet with 10 mg macitentan and 40 mg tadalafil, to be administered orally once daily.

Placebo macitentan

Intervention Type: DRUG

Matching placebo not containing any active substance but otherwise identical in appearance to the respective active drug tablet, to be administered orally once daily.

Placebo tadalafil

Intervention Type: DRUG

Matching placebo not containing any active substance but otherwise identical in appearance to the respective active drug tablet, to be administered orally once daily.

Macitentan mono-therapy + Placebo tadalafil + Placebo FDC

Subjects to receive macitentan 10 mg plus matching placebos for the two other study treatments.

Group Type: ACTIVE_COMPARATOR

Macitentan 10 mg

Intervention Type: DRUG

Film-coated tablet with 10 mg macitentan, to be administered orally once daily.

Placebo FDC

Intervention Type: DRUG

Matching placebo not containing any active substance but otherwise identical in appearance to the respective active drug tablet, to be administered orally once daily.

Placebo tadalafil

Intervention Type: DRUG

Matching placebo not containing any active substance but otherwise identical in appearance to the respective active drug tablet, to be administered orally once daily.

Tadalafil mono-therapy + Placebo macitentan + Placebo FDC

Subjects to receive tadalafil 40 mg (2 x 20 mg) plus matching placebos for the two other study treatments.

Group Type: ACTIVE_COMPARATOR

Tadalafil 40 mg

Intervention Type: DRUG

Film-coated tablet with 40 mg tadalafil (2 x 20 mg tablets), to be administered orally once daily.

Placebo FDC

Intervention Type: DRUG

Matching placebo not containing any active substance but otherwise identical in appearance to the respective active drug tablet, to be administered orally once daily.

Placebo macitentan

Intervention Type: DRUG

Matching placebo not containing any active substance but otherwise identical in appearance to the respective active drug tablet, to be administered orally once daily.

Interventions

FDC macitentan/tadalafil

Film-coated tablet with 10 mg macitentan and 40 mg tadalafil, to be administered orally once daily.

Intervention Type: DRUG

Macitentan 10 mg

Film-coated tablet with 10 mg macitentan, to be administered orally once daily.

Intervention Type: DRUG

Tadalafil 40 mg

Film-coated tablet with 40 mg tadalafil (2 x 20 mg tablets), to be administered orally once daily.

Intervention Type: DRUG

Placebo FDC

Matching placebo not containing any active substance but otherwise identical in appearance to the respective active drug tablet, to be administered orally once daily.

Intervention Type: DRUG

Placebo macitentan

Matching placebo not containing any active substance but otherwise identical in appearance to the respective active drug tablet, to be administered orally once daily.

Intervention Type: DRUG

Placebo tadalafil

Matching placebo not containing any active substance but otherwise identical in appearance to the respective active drug tablet, to be administered orally once daily.

Intervention Type: DRUG

Other Intervention Names

ACT-064992D; ACT-064992

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Actelion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hany Rofael, MD

Role: STUDY_DIRECTOR

Janssen, LP

Locations

Providence Medical Foundation

Fullerton, California, United States

University of Southern California

Los Angeles, California, United States

Piedmont Healthcare

Atlanta, Georgia, United States

WellStar Health System

Marietta, Georgia, United States

OSF HealthCare Cardiovascular Institute

Peoria, Illinois, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Norton Healthcare

Louisville, Kentucky, United States

Sparrow Clinical Research Institute

Lansing, Michigan, United States

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Washington University School Of Medicine

St Louis, Missouri, United States

VA Sierra Nevada Health Care System

Reno, Nevada, United States

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

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

Greenville, North Carolina, United States

Sanford Health

Fargo, North Dakota, United States

University of Cincinnati

Cincinnati, Ohio, United States

St. Elizabeth Hospital Mercy Bon Secors

Youngstown, Ohio, United States

Legacy Hospital

Portland, Oregon, United States

Oregon Health and Science University

Portland, Oregon, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Sanford Health

Sioux Falls, South Dakota, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Baylor Scott White - Plano

Plano, Texas, United States

WVU Health Sciences Center

Morgantown, West Virginia, United States

University of Wisconsin At Madison

Madison, Wisconsin, United States

Medical College of Wisconsin Froedtert Hospital

Milwaukee, Wisconsin, United States

Royal Adelaide Hospital

Adelaide, , Australia

Pulmonary Arterial Hypertension Clinic

Hobart, , Australia

Core Research Group

Milton, , Australia

Universidade Federal De Minas Gerais - Hospital das Clínicas

Belo Horizonte, , Brazil

Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa

Belo Horizonte, , Brazil

Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)

Botucatu, , Brazil

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

Fortaleza, , Brazil

Universidade Federal de Goias - Hospital das Clinicas da UFG

Goiânia, , Brazil

Hospital das Clinicas de Porto Alegre

Porto Alegre, , Brazil

Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, , Brazil

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

Porto Alegre, , Brazil

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

São Paulo, , Brazil

Hospital Das Clinicas Da Faculdade De Medicina Da USP

São Paulo, , Brazil

National Heart Hospital

Sofia, , Bulgaria

University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD

Sofia, , Bulgaria

Alberta Health Services

Calgary, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

London Health Sciences Centre

London, Ontario, Canada

Beijing Anzhen Hospital

Beijing, , China

The Second Xiangya Hospital of Central South Hospital

Changsha, , China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, , China

Jiangsu Province Hospital

Nanjing, , China

Shanghai Pulmonary Hospital

Shanghai, , China

The General Hospital of Northern Theater Command

Shenyang, , China

Tianjin Medical University General Hospital

Tianjin, , China

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, , China

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

Prague, , Czechia

Universitatsklinikum Bonn

Bonn, , Germany

Universitatsklinikum Carl Gustav Carus Dresden

Dresden, , Germany

Universitaetsklinikum Giessen

Giessen, , Germany

Universitat Greifswald

Greifswald, , Germany

Universitaetsklinikum Hamburg Eppendorf

Hamburg, , Germany

Thoraxklinik am Universitatsklinikum Heidelberg

Heidelberg, , Germany

Kardiologische Praxis Papenburg

Papenburg, , Germany

Universitaetsklinikum Regensburg

Regensburg, , Germany

Klinikum Würzburg Mitte gGmbH Standort Missioklinik

Würzburg, , Germany

Semmelweis Egyetem,Pulmonológiai Klinika

Budapest, , Hungary

Gottsegen György Országos Kardiológiai Intézet, Felnőtt kardiológiai osztály

Budapest, , Hungary

Pecsi Tudomanyegyetem Klinikai Kozpont

Pécs, , Hungary

Szegedi Tudomanyegyetem

Szeged, , Hungary

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Bari, , Italy

Cardiologia c/o Spedali Civili

Brescia, , Italy

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, , Italy

Azienda Ospedaliera San Gerardo

Monza, , Italy

Ospedale San Francesco

Nuoro, , Italy

IRCCS Policlinico San Matteo, Università degli studi di Pavi

Pavia, , Italy

Policlinico Umberto I

Roma, , Italy

The University of Tokyo Hospital

Bunkyō City, , Japan

Chiba University Hospital

Chiba, , Japan

Kyushu University Hospital

Fukuoka, , Japan

Fukushima Medical University Hospital

Fukushima, , Japan

Gunma University Hospital

Gunma, , Japan

Kure Kyosai Hospital

Hiroshima, , Japan

Tokai University Hospital

Isehara, , Japan

Kagoshima University Hospital

Kagoshima, , Japan

Kanazawa University Hospital

Kanazawa, , Japan

Kobe University Hospital

Kobe, , Japan

Kumamoto University Hospital

Kumamoto, , Japan

Kurume University Hospital

Kurume, , Japan

University Hospital Kyoto Prefectural University of Medicine

Kyoto, , Japan

Kyoto University Hospital

Kyoto, , Japan

Shinshu University Hospital

Matsumoto, , Japan

Kyorin University Hospital

Mitaka, , Japan

Nagasaki University Hospital

Nagasaki, , Japan

Okayama University Hospital

Okayama, , Japan

National Hospital Organization Okayama Medical Center

Okayama, , Japan

Sapporo Medical University Hospital

Sapporo, , Japan

Hokkaido University Hospital

Sapporo, , Japan

Tohoku University Hospital

Sendai, , Japan

National Cerebral and Cardiovascular Center

Suita-Shi, , Japan

Juntendo University Hospital

Tokyo, , Japan

Mie University Hospital

Tsu, , Japan

University of Tsukuba Hospital

Tsukuba, , Japan

Institut Jantung Negara (National Heart Institute)

Kuala Lumpur, , Malaysia

Sarawak Heart Center

Kuching, , Malaysia

Instituto Nacional de Cardiologia Dr. Ignacio Chavez

México, , Mexico

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

Monterrey, , Mexico

Klinika Kardiologii Z Oddzialem Intensywnego Nadzoru Kardiologicznego UM W Bialymstoku

Bialystok, , Poland

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

Bydgoszcz, , Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, , Poland

GCM SUM I Oddzial Kardiologii

Katowice, , Poland

Oddzial Kardiologii Wojewodzki Szpital Specjalistyczny im W Bieganskiego

Lodz, , Poland

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

Lublin, , Poland

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

Otwock, , Poland

Uniwersytecki Szpital Kliniczny nr 2 PUM Klinika Kardiologii

Szczecin, , Poland

Wojewodzki Szpital Specjalistyczny Oddzial Kardiologiczny

Wroclaw, , Poland

Altay Regional Cardiological Dispensary

Barnaul, , Russia

Scientific and Research Institution of Cardiovascular Diseases Complex Problems

Kemerovo, , Russia

National Medical Research Center of Cardiology of MoH of Russian Federation

Moscow, , Russia

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

Moscva, , Russia

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

Saint Petersburg, , Russia

Samara Regional Clinical Cardiological Dispensary

Samara, , Russia

Abdullah, IA

Durban, , South Africa

Dr Kalla

Lenasia, , South Africa

Hosp Clinic de Barcelona

Barcelona, , Spain

Hosp Univ Vall D Hebron

Barcelona, , Spain

Hosp. Univ. Ramon Y Cajal

Madrid, , Spain

Hosp Univ Fund Jimenez Diaz

Madrid, , Spain

Hosp. Univ. La Paz

Madrid, , Spain

Hosp Clinico Univ de Salamanca

Salamanca, , Spain

Hosp. Univ. Marques de Valdecilla

Santander, , Spain

Hosp. Virgen de La Salud

Toledo, , Spain

Hosp. Gral. Univ. Valencia

Valencia, , Spain

Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

National Cheng Kung University Hospital

Tainan, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Mackay Memorial Hospital

Taipei, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Chang-Gung Memorial Hospital, LinKou Branch

Taoyuan District, , Taiwan

Cukurova University Medical Faculty

Adana, , Turkey (Türkiye)

Hacettepe University Medical Faculty

Ankara, , Turkey (Türkiye)

Ankara University Medical Faculty

Ankara, , Turkey (Türkiye)

Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, , Turkey (Türkiye)

Istanbul University - Cerrahpasa Cardiology Institution

Istanbul, , Turkey (Türkiye)

Istanbul University Cerrahpasa Medical Faculty

Istanbul, , Turkey (Türkiye)

Marmara University Medical Faculty

Istanbul, , Turkey (Türkiye)

Ege University School of Medicine

Izmir, , Turkey (Türkiye)

Dokuz Eylul University Hospital

Izmir, , Turkey (Türkiye)

Kartal Kosuyolu Yuksek Ihtisas Egitim Ve Arastirma Hastanesi

Kartal Istanbul, , Turkey (Türkiye)

Konya Selcuk University Medical Faculty

Konya, , Turkey (Türkiye)

Mersin University Medical Faculty

Mersin, , Turkey (Türkiye)

Countries

United States; Australia; Brazil; Bulgaria; Canada; China; Czechia; Germany; Hungary; Italy; Japan; Malaysia; Mexico; Poland; Russia; South Africa; Spain; Taiwan; Turkey (Türkiye)

References

Fan F, Sun L, Yang Z, Wang L, Wang Q, Li J, Gu H, Xie W, Zhang N, Bin J, Rofael H, Friberg M, Hauser JA. Macitentan Plus Tadalafil Single-Tablet Combination Therapy in Chinese Patients With Pulmonary Arterial Hypertension: A Subgroup Analysis of the A DUE Study. Pulm Circ. 2025 Nov 16;15(4):e70194. doi: 10.1002/pul2.70194. eCollection 2025 Oct.

Reference Type: DERIVED

PMID: 41250682 (View on PubMed)

Grunig E, Jansa P, Fan F, Hauser JA, Pannaux M, Morganti A, Rofael H, Chin KM. Randomized Trial of Macitentan/Tadalafil Single-Tablet Combination Therapy for Pulmonary Arterial Hypertension. J Am Coll Cardiol. 2024 Jan 30;83(4):473-484. doi: 10.1016/j.jacc.2023.10.045.

Reference Type: DERIVED

PMID: 38267108 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217051&amp;parentIdentifier=AC-077A301&amp;attachmentIdentifier=6a92fb9d-e152-4929-aa6b-06238109e9a5&amp;fileName=AC-077A301_-_RRF_KOM.pptx&amp;versionIdentifier=

RRF KOM slides

Other Identifiers

2014-004786-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AC-077A301

Identifier Type: OTHER

Identifier Source: secondary_id

AC-077A301

Identifier Type: -

Identifier Source: org_study_id