A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (STELLAR)

Study Purpose

The objectives of this study are to evaluate the efficacy and safety of sotatercept treatment (plus background PAH therapy) versus placebo (plus background PAH therapy) at 24 weeks in adults with PAH.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Key

Inclusion Criteria:

1. Age ≥ 18 years. 2. Documented diagnostic right heart catheterization (RHC) at any time prior to screening confirming the diagnosis of WHO pulmonary arterial hypertension (PAH) Group 1 in any of the following subtypes:

- Idiopathic PAH.

- Heritable PAH.

- Drug/toxin-induced PAH.

- PAH associated with connective tissue disease.

- PAH associated with simple, congenital systemic to pulmonary shunts at least 1 year following repair.

3. Symptomatic PAH classified as WHO Functional Class II or

III. 4.

Baseline RHC performed during the Screening Period documenting a minimum pulmonary vascular resistance (PVR) of ≥ 5 Wood units (WU) and a pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure of ≤ 15 mmHg. 5. On stable doses of background PAH therapy and diuretics (i.e., patient-specific dose goal for each therapy already achieved) for at least 90 days prior to screening; for infusion prostacyclins, dose adjustment within 10% of optimal dose is allowed per medical practice. 6. 6MWD ≥ 150 and ≤ 500 m repeated twice at screening (measured at least 4 hours apart, but no longer than 1 week), and both values are within 15% of each other (calculated from the highest value) 7. Females of childbearing potential must:

- Have 2 negative urine or serum pregnancy tests as verified by the investigator prior to starting study therapy; she must agree to ongoing urine or serum pregnancy testing during the study and until 8 weeks after the last dose of the study drug.

- If sexually active, have used, and agree to use, highly effective contraception without interruption, for at least 28 days prior to starting the investigational product, during the study (including dose interruptions), and for 16 weeks (112 days) after discontinuation of study treatment.

- Refrain from breastfeeding a child or donating blood, eggs, or ovum for the duration of the study and for at least 16 weeks (112 days) after the last dose of study treatment.

8. Male participants must:

- Agree to use a condom, defined as a male latex condom or nonlatex condom NOT made out of natural (animal) membrane (e.g., polyurethane), during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 16 weeks (112 days) following investigational product discontinuation, even if he has undergone a successful vasectomy.

- Refrain from donating blood or sperm for the duration of the study and for 16 weeks (112 days) after the last dose of study treatment.

9. Ability to adhere to study visit schedule and understand and comply with all protocol requirements. 10. Ability to understand and provide written informed consent. Key

Exclusion Criteria:

1. Diagnosis of pulmonary hypertension WHO Groups 2, 3, 4, or 5. 2. Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH and PAH associated with portal hypertension. Exclusions in PAH Group I should also include schistosomiasis APAH and pulmonary veno occlusive disease. 3. Hemoglobin (Hgb) at screening above gender-specific upper limit of normal (ULN), per local laboratory test. 4. Baseline platelet count < 50,000/mm3 (< 50.0 x 109/L) at screening. 5. Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure > 160 mmHg or sitting diastolic blood pressure > 100 mmHg during screening visit after a period of rest. 6. Baseline systolic BP < 90 mmHg at screening. 7. Pregnant or breastfeeding women. 8. Any of the following clinical laboratory values at the screening visit:

- Estimated glomerular filtration rate (eGFR) < 30 mL/min/m2 (as defined by MDRD equation) - Serum alanine aminotransferase, aspartate aminotransferase, or total bilirubin levels > 3 × ULN (bilirubin criterion waived if there is a documented history of Gilbert's syndrome) 9.

Currently enrolled in or have completed any other investigational product study within 30 days for small molecule drugs or within 5 half-lives for biologics prior to the date of signed informed consent. 10. Prior exposure to sotatercept (ACE-011) or luspatercept (ACE 536) and/or excipients or known allergic reaction to either one. 11. Have full or partial pneumonectomy. 12. Pulmonary function test (PFT) values of forced vital capacity (FVC) < 60% predicted at the screening visit or within 6 months prior to the screening visit. If PFT is not available, a chest CT scan showing more than mild interstitial lung disease (ILD) performed at the screening visit or 1 year prior to it. 13. Initiation of an exercise program for cardiopulmonary rehabilitation within 90 days prior to the screening visit or planned initiation during the study (participants who are stable in the maintenance phase of a program and who will continue for the duration of the study are eligible). 14. History of more than mild obstructive sleep apnea that is untreated. 15. Known history of portal hypertension or chronic liver disease, including hepatitis B and/or hepatitis C (with evidence of recent infection and/or active virus replication), defined as mild to severe hepatic impairment (Child-Pugh Class A-C) 16. History of restrictive, constrictive or congestive cardiomyopathy. 17. History of atrial septostomy within 180 days prior to the screening visit. 18. Electrocardiogram (ECG) with Fridericia's corrected QT interval (QTcF) > 500 ms during the screening period. 19. Personal or family history of long QT syndrome (LQTS) or sudden cardiac death. 20. Left ventricular ejection fraction < 45% on historical echocardiogram within 6 months prior to the screening visit. 21. Any symptomatic coronary disease events within 6 months (prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain) within 6 months of the screening visit. Note: Anginal pain can be ignored as an exclusion criterion if coronary angiography shows no obstructions. 22. Cerebrovascular accident within 3 months prior to the screening visit. 23. Acutely decompensated heart failure within 30 days prior to the screening visit, as per investigator assessment. 24. Significant (≥ 2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease. 25. Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, vasopressin) within 30 days prior to the screening visit

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04576988
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Medical Director
Principal Investigator Affiliation	Merck Sharp & Dohme LLC
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Active, not recruiting
Countries	Argentina, Australia, Belgium, Brazil, Canada, Czechia, France, Germany, Israel, Italy, Korea, Republic of, Mexico, Netherlands, New Zealand, Poland, Serbia, Spain, Sweden, Switzerland, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Arterial Hypertension

Additional Details

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, parallel-group study in subjects with symptomatic Pulmonary Arterial Hypertension (PAH) who present with idiopathic or heritable PAH, PAH associated with connective tissue diseases (CTD), drug or toxin induced, post shunt correction PAH, or PAH presenting at least 1 year following the correction of congenital heart defects (CHDs), and currently on background PAH therapy. The primary efficacy endpoint of the study is exercise capacity, as measured by the 6-minute walk distance (6MWD) measured at 24 week following initiation of treatment. Approximately 284 participants will be enrolled and randomized 1:1 to receive either sotatercept or placebo on the background of stable standard-of-care PAH mediation. Study duration will be approximately 2 years A stratified Wilcoxon test will be used for analysis of the primary endpoint, with appropriate imputation for missing data, as detailed in the Statistical Analysis Plan. An unblinded, external, independent Data Monitoring Committee (DMC) will monitor participant safety throughout the course of the study. Participants completing this study will be eligible to receive sotatercept in a separate, open-label extension study.

Arms & Interventions

Arms

Experimental: Sotatercept plus background PAH theraphy

Sotatercept at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg administered subcutaneously (SC) every 21 days plus background PAH therapy

Placebo Comparator: Placebo plus background PAH therapy

Placebo administered (SC) every 21 days plus background PAH therapy

Interventions

Drug: - Sotatercept

Sotatercept at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg administered subcutaneously (SC) every 21 days plus background PAH therapy.

Drug: - Placebo

Placebo administered subcutaneously (SC) every 21 days plus background PAH therapy.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Phoenix, Arizona

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Arizona Pulmonary Specialists (Site 1010)

Phoenix, Arizona, 85012

Pulmonary Associates, PA (Site 1008), Phoenix, Arizona

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Pulmonary Associates, PA (Site 1008)

Phoenix, Arizona, 85032

University of Arizona (Site 1006), Tucson, Arizona

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University of Arizona (Site 1006)

Tucson, Arizona, 85724

San Diego, California

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University of California San Diego Medical Center (Site 1002)

San Diego, California, 92037

Sherman Oaks, California

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University of California - Davis Medical Center (Site 1064)

Sherman Oaks, California, 95817

Stanford, California

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Stanford University Medical Center (Site 1024)

Stanford, California, 94305

Harbor UCLA Medical Center (Site 1028), Torrance, California

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Harbor UCLA Medical Center (Site 1028)

Torrance, California, 90502

Aurora, Colorado

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University of Colorado Hospital (Site 1013)

Aurora, Colorado, 80045

Washington, District of Columbia

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The George Washington University Medical Faculty Associates (Site 1025)

Washington, District of Columbia, 20037

Mayo Clinic Jacksonville (Site 1045), Jacksonville, Florida

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Mayo Clinic Jacksonville (Site 1045)

Jacksonville, Florida, 32256

University of South Florida (Site 1043), Tampa, Florida

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University of South Florida (Site 1043)

Tampa, Florida, 33606

The Emory Clinic (Site 1030), Atlanta, Georgia

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The Emory Clinic (Site 1030)

Atlanta, Georgia, 30322

Norton Pulmonary Specialists (Site 1066), Louisville, Kentucky

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Norton Pulmonary Specialists (Site 1066)

Louisville, Kentucky, 40202

Tufts Medical Center - PPDS (Site 1012), Boston, Massachusetts

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Tufts Medical Center - PPDS (Site 1012)

Boston, Massachusetts, 02111

Brigham and Women's Hospital (Site 1014), Boston, Massachusetts

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Brigham and Women's Hospital (Site 1014)

Boston, Massachusetts, 02115

University of Michigan (Site 1011), Ann Arbor, Michigan

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University of Michigan (Site 1011)

Ann Arbor, Michigan, 48109-5936

University of Minnesota (Site 1062), Minneapolis, Minnesota

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University of Minnesota (Site 1062)

Minneapolis, Minnesota, 55455

Mayo Clinic (Site 1023), Rochester, Minnesota

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Mayo Clinic (Site 1023)

Rochester, Minnesota, 55905

Kansas City, Missouri

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University of Kansas Medical Center (Site 1020)

Kansas City, Missouri, 66160-7232

Saint Louis, Missouri

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Washington University School of Medicine (Site 1022)

Saint Louis, Missouri, 63110

Nebraska Medical Center (Site 1053), Omaha, Nebraska

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Nebraska Medical Center (Site 1053)

Omaha, Nebraska, 68105

Reno, Nevada

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Renown Institute for Heart & Vascular Health (Site 1055)

Reno, Nevada, 89502-1262

New York, New York

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New York Presbyterian Hospital (Site 1046)

New York, New York, 10032

Durham, North Carolina

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Duke University Medical Center (Site 1026)

Durham, North Carolina, 27710

Cincinnati, Ohio

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University of Cincinnati Medical Center (Site 1035)

Cincinnati, Ohio, 45219-2316

Cincinnati, Ohio

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The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital (Site 1001)

Cincinnati, Ohio, 45219

Cleveland, Ohio

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University Hospitals Cleveland Medical Center (Site 1005)

Cleveland, Ohio, 44106

Columbus, Ohio

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The Ohio State University Wexner Medical Center (Site 1032)

Columbus, Ohio, 43210

Portland, Oregon

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Oregon Health and Science University (Site 1054)

Portland, Oregon, 97232

University of Pennsylvania (Site 1047), Philadelphia, Pennsylvania

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University of Pennsylvania (Site 1047)

Philadelphia, Pennsylvania, 19104

Pittsburgh, Pennsylvania

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UPMC Presbyterian. UPMC Presbyterian Hospital (Site 1059)

Pittsburgh, Pennsylvania, 15213

Rhode Island Hospital (Site 1033), Providence, Rhode Island

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Rhode Island Hospital (Site 1033)

Providence, Rhode Island, 02903

Charleston, South Carolina

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Medical University of South Carolina - PPDS (Site 1003)

Charleston, South Carolina, 29425-8900

Knoxville, Tennessee

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Statcare Pulmonary Consultants - Knoxville (Site 1031)

Knoxville, Tennessee, 37919

Nashville, Tennessee

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Vanderbilt University Medical Center (Site 1027)

Nashville, Tennessee, 37232

Houston, Texas

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CHI St. Luke's Health Baylor College of Medicine Medical Center (Site 1044)

Houston, Texas, 77030

Houston Methodist Hospital (Site 1009), Houston, Texas

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Houston Methodist Hospital (Site 1009)

Houston, Texas, 77030

University of Utah - PPDS (Site 1049), Salt Lake City, Utah

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University of Utah - PPDS (Site 1049)

Salt Lake City, Utah, 84132

Seattle, Washington

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University of Washington Medical Center - Montlake (Site 1067)

Seattle, Washington, 98195-0001

International Sites

Pilar, Buenos Aires, Argentina

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Hospital Universitario Austral ( Site 1901)

Pilar, Buenos Aires, B1629ODT

Quilmes, Buenos Aires, Argentina

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Instituto de Investigaciones Clinicas Quilmes ( Site 1903)

Quilmes, Buenos Aires, B1878GEG

Centro Medico Dra De Salvo ( Site 1904), Ciudad Autonoma de Buenos Aires, Caba, Argentina

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Centro Medico Dra De Salvo ( Site 1904)

Ciudad Autonoma de Buenos Aires, Caba, C1426ABP

Sanatorio Parque ( Site 1905), Rosario, Santa Fe, Argentina

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Sanatorio Parque ( Site 1905)

Rosario, Santa Fe, 2000

Santa Fe, Argentina

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Hospital Provincial Dr. Jose M. Cullen ( Site 1902)

Santa Fe, , S2732XAA

Camperdown, New South Wales, Australia

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Royal Prince Alfred Hospital ( Site 1106)

Camperdown, New South Wales, 2050

Darlinghurst, New South Wales, Australia

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Saint Vincents Hospital Sydney ( Site 1102)

Darlinghurst, New South Wales, 2010

John Hunter Hospital ( Site 1101), New Lambton, New South Wales, Australia

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John Hunter Hospital ( Site 1101)

New Lambton, New South Wales, 2305

Westmead Hospital ( Site 1105), Westmead, New South Wales, Australia

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Westmead Hospital ( Site 1105)

Westmead, New South Wales, 2145

Prince Charles Hospital ( Site 1104), Chermside, Queensland, Australia

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Prince Charles Hospital ( Site 1104)

Chermside, Queensland, 4032

The Alfred Hospital ( Site 1110), Melbourne, Victoria, Australia

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The Alfred Hospital ( Site 1110)

Melbourne, Victoria, 3004

Hopital Erasme ( Site 1402), Brussels, Bruxelles-Capitale, Region De, Belgium

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Hopital Erasme ( Site 1402)

Brussels, Bruxelles-Capitale, Region De, 1070

U.Z.-Gasthuisberg ( Site 1401), Leuven, Vlaams-Brabant, Belgium

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U.Z.-Gasthuisberg ( Site 1401)

Leuven, Vlaams-Brabant, 3000

Porto Alegre, Rio Grande Do Sul, Brazil

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Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 1805)

Porto Alegre, Rio Grande Do Sul, 90020-090

Hospital Dia do Pulmao ( Site 1802), Blumenau, Santa Catarina, Brazil

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Hospital Dia do Pulmao ( Site 1802)

Blumenau, Santa Catarina, 89030-101

Sao Paulo, Brazil

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Instituto do Coracao - HC FMUSP ( Site 1803)

Sao Paulo, , 05403-000

Edmonton, Alberta, Canada

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University Of Alberta Hospital ( Site 2101)

Edmonton, Alberta, T6G 2E1

Ottawa, Ontario, Canada

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University of Ottawa Heart Institute ( Site 2104)

Ottawa, Ontario, K1Y 4W7

Jewish General Hospital ( Site 2103), Montreal, Quebec, Canada

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Jewish General Hospital ( Site 2103)

Montreal, Quebec, H3T 1E2

Fakultni Nemocnice Olomouc ( Site 2203), Olomouc, Olomoucky Kraj, Czechia

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Fakultni Nemocnice Olomouc ( Site 2203)

Olomouc, Olomoucky Kraj, 779 00

Prague, Praha 4, Czechia

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Institut Klinicke a Experimentalni Mediciny ( Site 2202)

Prague, Praha 4, 140 21

Praha, Praha, Hlavni Mesto, Czechia

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Vseobecna fakultni nemocnice v Praze ( Site 2201_

Praha, Praha, Hlavni Mesto, 128 08

Hopital Pasteur (Site 1311), Nice, Alpes-Maritimes, France

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Hopital Pasteur (Site 1311)

Nice, Alpes-Maritimes, 06002

Strasbourg, Bas-Rhin, France

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Hopitaux Universitaires de Strasbourg ( Site 1307)

Strasbourg, Bas-Rhin, 67000

Brest, Finistere, France

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CHRU Brest - Hopital Cavale Blanche (Site 1314)

Brest, Finistere, 29609

Groupe Hospitalier Sud ( Site 1312), Pessac, Gironde, France

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Groupe Hospitalier Sud ( Site 1312)

Pessac, Gironde, 33604

Toulouse, Haute-Garonne, France

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CHU de Toulouse - Hopital Larrey ( Site 1315)

Toulouse, Haute-Garonne, 31059

Montpellier, Herault, France

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Hopital Arnaud de Villeneuve ( Site 1301)

Montpellier, Herault, 34090

Grenoble, Isere, France

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CHU de Grenoble - Hopital Michallon ( Site 1303)

Grenoble, Isere, 38043

CHU Nantes - Hopital Laennec (Site 1309), Nantes, Loire-Atlantique, France

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CHU Nantes - Hopital Laennec (Site 1309)

Nantes, Loire-Atlantique, 44093

Saint-Priest-en-Jarez, Loire, France

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Centre Hospitalier Universitaire de Saint-Etienne ( Site 1302)

Saint-Priest-en-Jarez, Loire, 42055

CHU Angers (Site 1313), Angers, Maine-et-Loire, France

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CHU Angers (Site 1313)

Angers, Maine-et-Loire, 49100

Vandoeuvre Les Nancy, Meurthe-et-Moselle, France

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C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 1308)

Vandoeuvre Les Nancy, Meurthe-et-Moselle, 54500

CHRU Lille ( Site 1306), Lille, Nord, France

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CHRU Lille ( Site 1306)

Lille, Nord, 59037

Le Kremlin Bicetre, Val-de-Marne, France

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Centre Hospitalier Universitaire de Bicetre ( Site 1304)

Le Kremlin Bicetre, Val-de-Marne, 94270

Heidelberg, Baden-Wurttemberg, Germany

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Thoraxklinik-Heidelberg gGmbH (Site 1509)

Heidelberg, Baden-Wurttemberg, 69126

Krankenhaus Neuwittelsbach (Site 1510), Muenchen, Bayern, Germany

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Krankenhaus Neuwittelsbach (Site 1510)

Muenchen, Bayern, 80639

Regensburg, Bayern, Germany

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Universitaetsklinik Regensburg (Site 1503)

Regensburg, Bayern, 93053

Giessen, Hessen, Germany

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Universitaetsklinikum Giessen und Marburg GmbH ( Site 1512)

Giessen, Hessen, 35392

Hannover, Niedersachsen, Germany

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Medizinische Hochschule Hannover (Site 1505)

Hannover, Niedersachsen, 30625

Köln, Nordrhein-Westfalen, Germany

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Uniklinik Köln, Institut für Kliniche Chemie ( Site 1511)

Köln, Nordrhein-Westfalen, 50937

Universitätsklinikum Halle (Site 1502), Halle (Saale), Sachsen-Anhalt, Germany

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Universitätsklinikum Halle (Site 1502)

Halle (Saale), Sachsen-Anhalt, 06120

Dresden, Sachsen, Germany

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Universitaetsklinikum Carl Gustav Carus der TU Dresden (Site 1501)

Dresden, Sachsen, 01307

DRK Kliniken Berlin Westend ( Site 1507), Berlin, Germany

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DRK Kliniken Berlin Westend ( Site 1507)

Berlin, , 14050

Haifa, Israel

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Lady Davis Carmel Medical Center (Site 1705)

Haifa, , 34362

Meir Medical Center (Site 1707), Kefar Saba, Israel

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Meir Medical Center (Site 1707)

Kefar Saba, , 4428164

Rabin Medical Center (Site 1703), Petah Tikva, Israel

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Rabin Medical Center (Site 1703)

Petah Tikva, , 4941492

Sheba Medical Center (Site 1701), Tel Hashomer, Israel

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Sheba Medical Center (Site 1701)

Tel Hashomer, , 5265601

Roma, Italy

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Universita "La Sapienza" Policlinico Umberto I (Site 2402)

Roma, , 00161

Incheon, Korea, Republic of

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Gachon University Gil Medical Center (Site 3103)

Incheon, , 21565

Seoul, Korea, Republic of

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Seoul National University Hospital (Site 3102)

Seoul, , 03080

Seoul, Korea, Republic of

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Severance Hospital Yonsei University Health System - PPDS (Site 3101)

Seoul, , 03722

CIMAB SA de CV (Site 2502), Torreon, Coahuila, Mexico

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CIMAB SA de CV (Site 2502)

Torreon, Coahuila, 27000

Monterrey, Nuevo Leon, Mexico

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Unidad de Investigacion Clinica en Medicina, S.C. (Site 2505)

Monterrey, Nuevo Leon, 64718

Huixquilucan, Mexico

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Operadora de Hospitales Angeles. S.A. de C.V. -Sucursal Lomas (Site 2501)

Huixquilucan, , 52763

Maastricht, Limburg, Netherlands

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Maastricht University Medical Center (Site 2603)

Maastricht, Limburg, 6229 HX

VU Medisch Centrum (Site 2601), Amsterdam, Noord-Holland, Netherlands

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VU Medisch Centrum (Site 2601)

Amsterdam, Noord-Holland, 1081 HV

Christchurch, Canterbury, New Zealand

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University of Otago, Wellington (Site 2701)

Christchurch, Canterbury, 8011

Hamilton, Waikato, New Zealand

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Waikato District Health Board (Site 2702)

Hamilton, Waikato, 3204

Greenlane Clinical Centre (Site 2703), Auckland, New Zealand

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Greenlane Clinical Centre (Site 2703)

Auckland, , 1051

Krakow, Malopolskie, Poland

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Krakowski Szpital Specjalistyczny im. Jana Pawla II (Site 2801)

Krakow, Malopolskie, 31-202

Otwock, Mazowieckie, Poland

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Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina (Site 2802)

Otwock, Mazowieckie, 05-400

Bialystok, Podlaskie, Poland

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Uniwersytecki Szpital Kliniczny w Bialymstoku (Site 2803)

Bialystok, Podlaskie, 15-276

Clinical Center of Serbia (Site 2901), Belgrade, Beograd, Serbia

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Clinical Center of Serbia (Site 2901)

Belgrade, Beograd, 11000

Belgrade, Beograd, Serbia

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Institute of Cardiovascular Diseases Dedinje (Site 2903)

Belgrade, Beograd, 116550

Nis, Nisavski Okrug, Serbia

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University Clinical Center Nis (Site 2904)

Nis, Nisavski Okrug, 1800

Santander, Cantabria, Spain

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Hospital Universitario Marques de Valdecilla (Site 1601)

Santander, Cantabria, 39008

Majadahonda, Madrid, Spain

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Hospital Universitario Puerta de Hierro-Majadahonda (Site 1604)

Majadahonda, Madrid, 28222

Barcelona, Spain

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Hospital Universitari Vall d'Hebron (Site 1605)

Barcelona, , 08035

Hospital Clinic de Barcelona (Site 1602), Barcelona, Spain

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Hospital Clinic de Barcelona (Site 1602)

Barcelona, , 08036

Madrid, Spain

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Hospital Universitario Ramon y Cajal (Site 1609)

Madrid, , 28034

Madrid, Spain

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Hospital Universitario Marques de Valdecilla (Site 1603)

Madrid, , 28041

Salamanca, Spain

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Hospital Clinico Universitario de Salamanca (Site 1608)

Salamanca, , 37007

Akademiska Sjukhuset (Site 3204), Uppsala, Uppsala Lan, Sweden

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Akademiska Sjukhuset (Site 3204)

Uppsala, Uppsala Lan, 751 85

Goteborg, Vastra Gotalands Lan, Sweden

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Sahlgrenska Universitets Sjukhuset (Site 3201)

Goteborg, Vastra Gotalands Lan, 413 45

Thonex, Geneve, Switzerland

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Hopitaux Universitaires de Geneve HUG (Site 3302)

Thonex, Geneve, 1226

Universitaetsspital Zuerich (Site 3301), Zurich, Switzerland

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Universitaetsspital Zuerich (Site 3301)

Zurich, , 8091

Glasgow, Glasgow City, United Kingdom

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Golden Jubilee National Hospital (Site 1204)

Glasgow, Glasgow City, G81 4DY

London, London, City Of, United Kingdom

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Royal Free London NHS Foundation Trust (Site 1202)

London, London, City Of, NW3 2QG

Royal Brompton Hospital (Site 1206), London, London, City Of, United Kingdom

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Royal Brompton Hospital (Site 1206)

London, London, City Of, SW3 6NP

London, London, City Of, United Kingdom

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Imperial College Healthcare NHS Trust (Site 1203)

London, London, City Of, W12 0HS

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