A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16)

Study Purpose

This is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. The objective of this study is to evaluate the efficacy, safety and tolerability of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. Efficacy is measured by change from baseline in pulmonary vascular resistance (PVR, primary endpoint) and 6-minute walk distance (6MWD, key secondary endpoint).

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 - 85 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

Participants must meet the following criteria to be enrolled in this proof-of-concept study: 1. Age 18 to 85 years. 2. Clinical diagnosis of HFpEF: • Left ventricular ejection fraction ≥50%, with no history of LVEF below 45% in more than two consecutive measurements under stable conditions. 3. Demonstrated Cpc-PH by all of the following:
  • - Baseline RHC performed within 28 days of randomization documenting a minimum PVR of ≥320 dyn•sec/cm5 (4 wood units) - Mean pulmonary arterial pressure (mPAP) of >20 mmHg.
  • - Pulmonary capillary wedge pressure (PCWP) >15 mmHg but < 30 mmHg.
4. New York Heart Association FC of II or
  • III. 5.
Six-minute Walk Distance ≥100 m repeated twice during Screening and both values within 15% of each other, calculated from the highest value. 6. Chronic medication for HF or for any underlying condition, administered at a stable (per investigator) dose for ≥30 days prior to Visit 1. Diuretics and/or anticoagulants are excepted from this rule but should not be newly started or stopped within 30 days of Visit 1, and a prescribed dose change should not occur within 7 days of Visit 1. Anticoagulation may be suspended for RHC if necessary. 7. Women of childbearing potential must:
  • - Have 2 negative urine or serum pregnancy tests as verified by the investigator during the Screening Period; must agree to ongoing pregnancy testing during the course of the study and until 8 weeks after the last dose of the study drug.
  • - If sexually active with a male partner: use highly effective contraception without interruption for at least 28 days prior to starting the investigational product AND agree to use the same highly effective contraception in combination with a barrier method 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 drug.
8. Male participants must:
  • - Agree to use a condom, defined as a male latex condom or non latex 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 drug.
9. Ability to adhere to the study visit schedule and understand and comply with all protocol requirements. 10. Agreement to not participate in any other trials of investigational drugs/devices while enrolled in the A011-16 study. 11. Ability to understand and provide documented consent for participation.

Exclusion Criteria:

Participants will be excluded from the study if any of the following criteria are met: 1. A diagnosis of PH in WHO Group 1, WHO Group 3, WHO Group 4, or WHO Group 5. 2. Clinically significant and active lung disease:
  • - Chronic obstructive pulmonary disease with post-bronchodilator forced expiratory volume in the first second (FEV1) <60% predicted.
  • - Restrictive lung disease with total lung capacity <70% predicted.
  • - More than mild interstitial lung disease (ILD), with FVC<70% or FEV1<60% predicted (still appropriate if absence of more than mild ILD, fibrosis, or COPD on computed tomography [CT] imaging) 3.
Cardiovascular co-morbidities, which include any of the following:
  • - History of more than mild mitral or aortic stenosis.
  • - Ongoing more than mild mitral or aortic regurgitation.
  • - More than one valve replacement or repair (mechanical or biomechanical) or anticipation of any valve replacement or repair.
  • - Severe tricuspid regurgitation due to primary valvular disease.
  • - Occurrence of myocardial infarction, acute coronary syndrome, coronary artery bypass graft or percutaneous coronary intervention within 180 days of Visit 1.
  • - History of serious life-threatening or hemodynamically significant arrhythmia.
  • - History of or anticipated heart transplant or ventricular assist device implantation.
  • - History of implantable cardioverter defibrillator placement or anticipated implantation of pacemaker, pacemaker implantation within 30 days of Screening.
  • - Anticipated implantation of pacemaker, pacemaker implantation within 30 days of Screening or history of implantable cardioverter defibrillator placement.
  • - Occurrence of myocardial infarction within 180 days of Visit 1.
  • - History of known pericardial constriction, hypertrophic cardiomyopathy, sarcoidosis, or amyloid cardiomyopathy.
  • - Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure >160 mmHg or sitting diastolic blood pressure >110 mmHg during Screening after a period of rest.
  • - Systemic hypotension as evidenced by sitting systolic blood pressure <90 mmHg or sitting diastolic blood pressure <50 mmHg during Screening.
  • - Resting heart rate of <45 bpm or >115 bpm.
  • - Stroke within 90 days of Visit 1.
  • - Acutely decompensated HF that required hospitalization within 30 days of Visit 1.
  • - Electrocardiogram during Screening Period with Fridericia's corrected QT interval (QTcF) >470 msec for males or >480 msec for females, or >500 msec if a ventricular conduction defect (right bundle branch block; left bundle branch block; or interventricular conduction delay) is present.
  • - Personal or family history of Brugada syndrome, sudden cardiac arrest or unexplained sudden cardiac death or arrest.
  • - Personal or family history of long QT syndrome unless the participant's ECG shows a normal QTc.
  • - Arrhythmogenic right ventricular dysplasia (ARVD) unless the participant has a recent cardiac MRI that shows no evidence of this diagnosis.
4. Hospitalization for any worsening of medical conditions or any significant surgery per investigator within 30 days of Visit 1. 5. Received any approved PAH-specific therapies (i.e., endothelin receptor antagonists, prostacyclin analogs, phosphodiesterase-5 inhibitors, soluble guanylate cyclase stimulators) within 30 days of Visit 1.The use of an oral phosphodiesterase type 5 inhibitor, if only indicated for erectile dysfunction, is permitted, if not administered within 48 hours of a study visit or procedure. 6. Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, vasopressin,or levosimendan) within 30 days of Visit 1. 7. Received erythropoietin within 6 months of Visit 1. 8. Known history of chronic liver disease, including untreated hepatitis B and/or hepatitis C (with evidence of recent infection and/or active virus replication), with severe hepatic impairment and/or cirrhosis (e.g., hepatic encephalopathy) 9. Prior exposure to sotatercept or luspatercept. 10. Currently enrolled in or have completed any other investigational product study within 30 days for small molecule drugs or within 5 half-lives for investigational biologics prior to the date of documented consent. 11. Initiation of an exercise program for cardiopulmonary rehabilitation within 90 days of Visit 1 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). 12. Any of the following clinical laboratory values prior to Visit 1 as specified:
  • - Hemoglobin (Hgb) above the gender-specific upper limit of normal (ULN) per local laboratory test within 28 days of Visit 1or <10 g/dL per local laboratory within 28 days of Visit 1.
  • - Serum alanine aminotransferase or aspartate aminotransferase levels >3× ULN or total bilirubin >3× ULN within 28 days of Visit 1.
  • - Estimated glomerular filtration rate <30 ml/min/1.73 m2 (4-variable Modification of Diet in Renal Disease equation) within 28 days of Visit 1 or required renal replacement therapy within 90 days of Visit 1.
  • - Glycated hemoglobin (HbA1c) >10% within 28 days of Visit 1.
  • - Platelet count < 75,000/mm3 within 28 days of Visit 1.
13. History of severe allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or excipients in the investigational product . 14. Major surgery within 60 days of Visit 1. Participants must have completely recovered from any previous surgery prior to Visit 1. 15. Prior organ transplantation (e.g., heart, lung, liver, kidney), bone marrow transplantation, or life expectancy of < 12 months. 16. Pregnancy or breastfeeding in females. 17. Active malignancy, with the exception of fully excised or treated basal cell carcinoma, cervical carcinoma in situ, or ≤ 2 squamous cell carcinomas of the skin. 18. History of clinically significant (as determined by the investigator) endocrine, hematologic, hepatic, (auto)immune, infectious (requiring chronic antibiotics), metabolic, urologic, pulmonary, neurologic, neuromuscular, dermatologic, psychiatric, renal, and/or another disease that may limit participation in the study. 19. Body mass index ≥50 kg/m2. 20. More than mild obstructive sleep apnea (treated or untreated). 21. Any non-cardiopulmonary condition or acute/chronic impairment(s) (other than dyspnea) that limits the ability to perform 6-minute walk test (6MWT).

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.

NCT04945460
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 2
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 & Co., Inc., Rahway, NJ USA
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 Recruiting
Countries Belgium, Canada, France, Germany, Israel, Italy, Poland, Spain, Sweden, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Hypertension, Pulmonary
Study Website: View Trial Website
Additional Details

Participants enrolled in the study will have a diagnosis of Cpc-PH due to HFpEF with New York Heart Association (NYHA) functional class (FC) II or

  • III. Participants will be randomly assigned in a 1:1:1 ratio to 1 of the 3 treatment groups (placebo, 0.3mg/kg sotatercept and 0.7mg/kg sotatercept) during the placebo-controlled Treatment Period.
In the extension phase, sotatercept-treated participants will continue on their current dose. Placebo participants will be re-randomized in a 1:1 ratio to one of the two sotatercept treatment groups utilized in the placebo-controlled Treatment Period. Each participant will be enrolled in the study for up to 114 weeks, including a 28-day Screening Period, a 24-week, double-blind, placebo-controlled Treatment Period, an 18-month Extension Period, and an 8-week Follow-up Period.

Arms & Interventions

Arms

Placebo Comparator: Placebo

Delivered subcutaneously (SC) every 3 weeks (Q3W) for 24 weeks in the placebo-controlled treatment period. After completion of the placebo-controlled treatment period, placebo participants will enter into 1 of the 2 sotatercept dose groups in an extension period.

Experimental: Sotatercept 0.3 mg/kg

Participants will receive sotatercept SC at a dose level of 0.3 mg/kg Q3W for 24 weeks in the placebo-controlled treatment period. After completion of the placebo-controlled treatment period, participants will continue to receive sotatercept SC at a dose level of 0.3 mg/kg Q3W in an extension period for up to 18 months.

Experimental: Sotatercept 0.3 mg/kg, escalating to 0.7 mg.kg

Sotatercept SC at a starting dose level of 0.3 mg/kg for 3 dosing visits (Q3W), then escalating to 0.7 mg/kg SC on the fourth dosing visit and Q3W for the remainder of the 24-week treatment Period.

Experimental: Extension Period: Placebo Crossed Over to Sotatercept 0.3 mg/kg

After the placebo-controlled treatment period, placebo participants will cross over to receive sotatercept SC at a dose of 0.3 mg/kg Q3W for up to 18 months in an extension period.

Experimental: Extension Period: Placebo Crossed Over to Sotatercept 0.3 mg/kg, escalating to 0.7 mg.kg

After the placebo-controlled treatment period, placebo participants will cross over to receive sotatercept SC at a starting dose level of 0.3 mg/kg for 3 dosing visits (Q3W), then escalating to 0.7 mg/kg SC on the fourth dosing visit and then Q3W for up to 18 months in an extension period.

Interventions

Drug: - Sotatercept 0.3 mg/kg

Administered by subcutaneous injection. Sotatercept (ACE-011) is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1.

Drug: - Placebo

Administered by subcutaneous injection

Drug: - Sotatercept 0.3 mg/kg escalating to 0.7 mg/kg

Administered by subcutaneous injection. Sotatercept (ACE-011) is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1.

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.

PULMONARY ASSOCIATES, P.A. ( Site 1008), Phoenix, Arizona

Status

Recruiting

Address

PULMONARY ASSOCIATES, P.A. ( Site 1008)

Phoenix, Arizona, 85032

Site Contact

Study Coordinator

Trialsites@merck.com

602-258-4951

University of Arizona ( Site 1006), Tucson, Arizona

Status

Recruiting

Address

University of Arizona ( Site 1006)

Tucson, Arizona, 85724-0001

Site Contact

Study Coordinator

Trialsites@merck.com

520-626-8000

Cedars Sinai Medical Center ( Site 1082), Los Angeles, California

Status

Recruiting

Address

Cedars Sinai Medical Center ( Site 1082)

Los Angeles, California, 90048

Site Contact

Study Coordinator

Trialsites@merck.com

310-423-3713

Orange, California

Status

Recruiting

Address

University of California Irvine ( Site 1086)

Orange, California, 92868

Site Contact

Study Coordinator

Trialsites@merck.com

949-824-6256

Santa Barbara, California

Status

Recruiting

Address

Jeffrey S.Sager MD Medical Corporation ( Site 1060)

Santa Barbara, California, 93105-5311

Site Contact

Study Coordinator

Trialsites@merck.com

805-845-1500

Stanford University ( Site 1024), Stanford, California

Status

Active, not recruiting

Address

Stanford University ( Site 1024)

Stanford, California, 94305

Torrance, California

Status

Recruiting

Address

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 1028)

Torrance, California, 90502

Site Contact

Study Coordinator

Trialsites@merck.com

310-222-3560

University Of Colorado ( Site 1013), Aurora, Colorado

Status

Recruiting

Address

University Of Colorado ( Site 1013)

Aurora, Colorado, 80045

Site Contact

Study Coordinator

Trialsites@merck.com

720-848-2786

Littleton, Colorado

Status

Recruiting

Address

South Denver Cardiology Associates ( Site 1091)

Littleton, Colorado, 80120

Site Contact

Study Coordinator

Trialsites@merck.com

303-715-2210

Winchester Chest Clinic ( Site 1093), New Haven, Connecticut

Status

Recruiting

Address

Winchester Chest Clinic ( Site 1093)

New Haven, Connecticut, 06519-1304

Site Contact

Study Coordinator

Trialsites@merck.com

203-688-1861

Washington, District of Columbia

Status

Recruiting

Address

The George Washington University Medical Faculty Associates ( Site 1025)

Washington, District of Columbia, 20037-3201

Site Contact

Study Coordinator

Trialsites@merck.com

202-795-2792

Bay Area Cardiology ( Site 1071), Brandon, Florida

Status

Recruiting

Address

Bay Area Cardiology ( Site 1071)

Brandon, Florida, 33511

Site Contact

Study Coordinator

Trialsites@merck.com

813-684-6000

Jacksonville, Florida

Status

Recruiting

Address

Mayo Clinic Jacksonville - PPDS ( Site 1045)

Jacksonville, Florida, 32224

Site Contact

Study Coordinator

Trialsites@merck.com

904-953-2381

AdventHealth Orlando ( Site 1058), Orlando, Florida

Status

Recruiting

Address

AdventHealth Orlando ( Site 1058)

Orlando, Florida, 32803

Site Contact

Study Coordinator

Trialsites@merck.com

407-303-7556

Tampa General Hospital ( Site 1043), Tampa, Florida

Status

Recruiting

Address

Tampa General Hospital ( Site 1043)

Tampa, Florida, 33606

Site Contact

Study Coordinator

Trialsites@merck.com

813-259-0826

Piedmont Atlanta Hospital ( Site 1085), Atlanta, Georgia

Status

Recruiting

Address

Piedmont Atlanta Hospital ( Site 1085)

Atlanta, Georgia, 30309-1281

Site Contact

Study Coordinator

Trialsites@merck.com

770-948-6041

Emory University ( Site 1030), Atlanta, Georgia

Status

Recruiting

Address

Emory University ( Site 1030)

Atlanta, Georgia, 30322-1013

Site Contact

Study Coordinator

Trialsites@merck.com

404-712-1370

Boise, Idaho

Status

Recruiting

Address

Saint Alphonsus Regional Medical Center ( Site 1097)

Boise, Idaho, 83704-8880

Site Contact

Study Coordinator

Trialsites@merck.com

208-367-7676

Chicago, Illinois

Status

Recruiting

Address

University of Illinois Hospital ( Site 1095)

Chicago, Illinois, 60612

Site Contact

Study Coordinator

Trialsites@merck.com

312-355-5918

Indianapolis, Indiana

Status

Recruiting

Address

IU Health Advanced Heart and Lung Care ( Site 1092)

Indianapolis, Indiana, 46202-1218

Site Contact

Study Coordinator

Trialsites@merck.com

317-962-9700

Indianapolis, Indiana

Status

Recruiting

Address

Ascension Medical Group St. Vincent ( Site 1076)

Indianapolis, Indiana, 46260

Site Contact

Study Coordinator

Trialsites@merck.com

317-338-6666

Iowa City, Iowa

Status

Recruiting

Address

University of Iowa Hospital and Clinics ( Site 1050)

Iowa City, Iowa, 52242

Site Contact

Study Coordinator

Trialsites@merck.com

319-356-2577

Kansas City, Kansas

Status

Recruiting

Address

University of Kansas Medical Center ( Site 1020)

Kansas City, Kansas, 66160

Site Contact

Study Coordinator

Trialsites@merck.com

913-588-2314

Louisville, Kentucky

Status

Active, not recruiting

Address

Norton Pulmonary Specialists ( Site 1066)

Louisville, Kentucky, 40202

New Orleans, Louisiana

Status

Recruiting

Address

University Medical Center New Orleans ( Site 1057)

New Orleans, Louisiana, 70112

Site Contact

Study Coordinator

Trialsites@merck.com

504-903-7302

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

Status

Recruiting

Address

Tufts Medical Center - PPDS ( Site 1012)

Boston, Massachusetts, 02111

Site Contact

Study Coordinator

Trialsites@merck.com

617-636-2892

Boston, Massachusetts

Status

Recruiting

Address

Brigham and Women's Hospital [Boston, MA] ( Site 1014)

Boston, Massachusetts, 02215

Site Contact

Study Coordinator

Trialsites@merck.com

617-525-1267

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

Status

Recruiting

Address

University of Michigan ( Site 1011)

Ann Arbor, Michigan, 48109

Site Contact

Study Coordinator

Trialsites@merck.com

734-232-3741

Minneapolis, Minnesota

Status

Completed

Address

University of Minnesota Hospitals ( Site 1062)

Minneapolis, Minnesota, 55455

Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine [Saint Louis, MO] ( Site 1022)

Saint Louis, Missouri, 63110

Site Contact

Study Coordinator

Trialsites@merck.com

314-747-8174

Omaha, Nebraska

Status

Recruiting

Address

University of Nebraska Medical Center ( Site 1053)

Omaha, Nebraska, 68198

Site Contact

Study Coordinator

Trialsites@merck.com

402-559-7182

Pulmonary Health Physicians ( Site 1080), Liverpool, New York

Status

Recruiting

Address

Pulmonary Health Physicians ( Site 1080)

Liverpool, New York, 13088

Site Contact

Study Coordinator

Trialsites@merck.com

315-475-8402

New York, New York

Status

Recruiting

Address

Weill Cornell Medical College ( Site 1046)

New York, New York, 10021-9800

Site Contact

Study Coordinator

Trialsites@merck.com

212-746-6645

Rochester, New York

Status

Recruiting

Address

University of Rochester Medical Center - PPDS ( Site 1039)

Rochester, New York, 14642

Site Contact

Study Coordinator

Trialsites@merck.com

585-275-7434

Durham, North Carolina

Status

Recruiting

Address

Duke University Medical Center ( Site 1026)

Durham, North Carolina, 27710-4000

Site Contact

Study Coordinator

Trialsites@merck.com

919-668-2646

Cincinnati, Ohio

Status

Recruiting

Address

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

Cincinnati, Ohio, 45219

Site Contact

Study Coordinator

Trialsites@merck.com

515-585-1777

Cleveland, Ohio

Status

Recruiting

Address

University Hospitals Cleveland Medical Center ( Site 1005)

Cleveland, Ohio, 44106

Site Contact

Study Coordinator

Trialsites@merck.com

216-844-2878

Cleveland Clinic Foundation ( Site 1065), Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic Foundation ( Site 1065)

Cleveland, Ohio, 44195

Site Contact

Study Coordinator

Trialsites@merck.com

216-444-2200

Columbus, Ohio

Status

Recruiting

Address

Ohio State University Wexner Medical Center ( Site 1032)

Columbus, Ohio, 43221

Site Contact

Study Coordinator

Trialsites@merck.com

614-293-8000

Toledo, Ohio

Status

Completed

Address

University of Toledo Medical Center ( Site 1070)

Toledo, Ohio, 43614

Portland, Oregon

Status

Recruiting

Address

Oregon Health Science University ( Site 1054)

Portland, Oregon, 97239-3098

Site Contact

Study Coordinator

Trialsites@merck.com

503-494-8311

Allegheny General Hospital ( Site 1088), Pittsburgh, Pennsylvania

Status

Recruiting

Address

Allegheny General Hospital ( Site 1088)

Pittsburgh, Pennsylvania, 15212-4737

Site Contact

Study Coordinator

Trialsites@merck.com

412-359-8420

Wynnewood, Pennsylvania

Status

Recruiting

Address

Lankenau Institute for Medical Research ( Site 1089)

Wynnewood, Pennsylvania, 19096

Site Contact

Study Coordinator

Trialsites@merck.com

610-645-2494

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

Status

Recruiting

Address

Rhode Island Hospital ( Site 1033)

East Providence, Rhode Island, 02915

Site Contact

Study Coordinator

Trialsites@merck.com

401-444-0369

Charleston, South Carolina

Status

Recruiting

Address

Medical University of South Carolina - PPDS ( Site 1003)

Charleston, South Carolina, 29425-0001

Site Contact

Study Coordinator

Trialsites@merck.com

843-792-3162

Knoxville, Tennessee

Status

Recruiting

Address

Statcare Pulmonary Consultants - Knoxville ( Site 1031)

Knoxville, Tennessee, 37919

Site Contact

Study Coordinator

Trialsites@merck.com

941-924-9800

Murray, Utah

Status

Recruiting

Address

Intermountain Medical Center ( Site 1079)

Murray, Utah, 84107

Site Contact

Study Coordinator

Trialsites@merck.com

801-507-3747

Falls Church, Virginia

Status

Recruiting

Address

Inova Heart and Vascular Institute ( Site 1078)

Falls Church, Virginia, 22042

Site Contact

Study Coordinator

Trialsites@merck.com

703-776-3610

Richmond, Virginia

Status

Recruiting

Address

Bon Secours St. Mary's Hospital ( Site 1069)

Richmond, Virginia, 23226

Site Contact

Study Coordinator

Trialsites@merck.com

804-591-3533

West Virginia University ( Site 1081), Morgantown, West Virginia

Status

Active, not recruiting

Address

West Virginia University ( Site 1081)

Morgantown, West Virginia, 26506

Milwaukee, Wisconsin

Status

Recruiting

Address

Aurora St Luke's Medical Center ( Site 1083)

Milwaukee, Wisconsin, 53215

Site Contact

Study Coordinator

Trialsites@merck.com

414-649-3780

Milwaukee, Wisconsin

Status

Recruiting

Address

Froedtert Hospital & the Medical College of Wisconsin ( Site 1051)

Milwaukee, Wisconsin, 53226

Site Contact

Study Coordinator

Trialsites@merck.com

414-955-0500

International Sites

Hôpital Erasme ( Site 1402), Anderlecht, Bruxelles-Capitale, Region De, Belgium

Status

Recruiting

Address

Hôpital Erasme ( Site 1402)

Anderlecht, Bruxelles-Capitale, Region De, 1070

Site Contact

Study Coordinator

Trialsites@merck.com

+3225553111

Leuven, Vlaams-Brabant, Belgium

Status

Recruiting

Address

UZ Leuven - Campus Gasthuisberg ( Site 1401)

Leuven, Vlaams-Brabant, 3000

Site Contact

Study Coordinator

Trialsites@merck.com

+3216341245

University Of Alberta ( Site 2101), Edmonton, Alberta, Canada

Status

Recruiting

Address

University Of Alberta ( Site 2101)

Edmonton, Alberta, T6G 2B7

Site Contact

Study Coordinator

Trialsites@merck.com

(780) 407-1586

Hamilton, Ontario, Canada

Status

Recruiting

Address

Hamilton General Hospital-Special Immunology Services Clinic ( Site 2110)

Hamilton, Ontario, L8L 2X2

Site Contact

Study Coordinator

Trialsites@merck.com

(905) 524-2424

Toronto, Ontario, Canada

Status

Recruiting

Address

University Health Network c/o Toronto General Hospital ( Site 2109)

Toronto, Ontario, M5G 2C4

Site Contact

Study Coordinator

Trialsites@merck.com

416-340-4043

Sainte Foy, Quebec, Canada

Status

Recruiting

Address

Institut Universitaire de Cardiologie et de Pneumologie ( Site 2107)

Sainte Foy, Quebec, G1V 4G5

Site Contact

Study Coordinator

Trialsites@merck.com

418-656-8711

Hôpital Pasteur - CHU Nice ( Site 1311), Nice, Alpes-Maritimes, France

Status

Recruiting

Address

Hôpital Pasteur - CHU Nice ( Site 1311)

Nice, Alpes-Maritimes, 06000

Site Contact

Study Coordinator

Trialsites@merck.com

+33492038473

Besançon, Doubs, France

Status

Recruiting

Address

Centre Hospitalier Universitaire du Besancon ( Site 1324)

Besançon, Doubs, 25000

Site Contact

Study Coordinator

Trialsites@merck.com

+33381668624

Toulouse, Haute-Garonne, France

Status

Recruiting

Address

Hopital de Rangueil du Toulouse ( Site 1322)

Toulouse, Haute-Garonne, 31400

Site Contact

Study Coordinator

Trialsites@merck.com

+33561323240

Montpellier, Herault, France

Status

Recruiting

Address

CHU Montpellier Hôpital Arnaud de VIlleneuve ( Site 1301)

Montpellier, Herault, 34090

Site Contact

Study Coordinator

Trialsites@merck.com

+33 4 67 33 67 33

Hôpital Pontchaillou ( Site 1319), Rennes, Ille-et-Vilaine, France

Status

Recruiting

Address

Hôpital Pontchaillou ( Site 1319)

Rennes, Ille-et-Vilaine, 35033

Site Contact

Study Coordinator

Trialsites@merck.com

+33299282525

Grenoble cedex 09, Isere, France

Status

Recruiting

Address

Centre Hospitalier Universitaire de Grenoble ( Site 1303)

Grenoble cedex 09, Isere, 38043

Site Contact

Study Coordinator

Trialsites@merck.com

+33476765523

Nantes, Loire-Atlantique, France

Status

Recruiting

Address

CHU de Nantes - Hoptal Nord Laennec ( Site 1309)

Nantes, Loire-Atlantique, 44000

Site Contact

Study Coordinator

Trialsites@merck.com

+33240165023

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

Status

Recruiting

Address

CHU Angers ( Site 1313)

Angers, Maine-et-Loire, 49933

Site Contact

Study Coordinator

Trialsites@merck.com

+33241353695

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France

Status

Recruiting

Address

CHRU de Nancy Hopitaux de Brabois ( Site 1308)

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500

Site Contact

Study Coordinator

Trialsites@merck.com

+33383154021

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

Status

Recruiting

Address

CHRU Lille ( Site 1306)

Lille, Nord, 59037

Site Contact

Study Coordinator

Trialsites@merck.com

+33320446011

CHU de Rouen ( Site 1323), Rouen, Seine-Maritime, France

Status

Recruiting

Address

CHU de Rouen ( Site 1323)

Rouen, Seine-Maritime, 76000

Site Contact

Study Coordinator

Trialsites@merck.com

33232888207

Le Kremlin Bicêtre, Val-de-Marne, France

Status

Recruiting

Address

Centre Hospitalier Universitaire de Bicetre ( Site 1304)

Le Kremlin Bicêtre, Val-de-Marne, 94270

Site Contact

Study Coordinator

Trialsites@merck.com

+33145212121

Heidelberg, Baden-Wurttemberg, Germany

Status

Recruiting

Address

Thoraxklinik-Heidelberg gGmbH ( Site 1509)

Heidelberg, Baden-Wurttemberg, 69126

Site Contact

Study Coordinator

Trialsites@merck.com

+49 6221 3960

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

Status

Recruiting

Address

Krankenhaus Neuwittelsbach ( Site 1510)

München, Bayern, 80639

Site Contact

Study Coordinator

Trialsites@merck.com

+49 89 13040

Regensburg, Bayern, Germany

Status

Recruiting

Address

University Hospital Regensburg ( Site 1503)

Regensburg, Bayern, 93053

Site Contact

Study Coordinator

Trialsites@merck.com

+49941944489

Bad Nauheim, Hessen, Germany

Status

Recruiting

Address

Kerckhoff-Klinik-Forschungs-GmbH ( Site 1514)

Bad Nauheim, Hessen, 61231

Site Contact

Study Coordinator

Trialsites@merck.com

+4960329962135

Gießen, Hessen, Germany

Status

Recruiting

Address

Universitätsklinikum Gießen und Marburg GmbH ( Site 1512)

Gießen, Hessen, 35392

Site Contact

Study Coordinator

Trialsites@merck.com

+496419945113

Hannover, Niedersachsen, Germany

Status

Recruiting

Address

Medizinische Hochschule Hannover ( Site 1505)

Hannover, Niedersachsen, 30625

Site Contact

Study Coordinator

Trialsites@merck.com

+495115329184

Uniklinik Köln ( Site 1511), Cologne, Nordrhein-Westfalen, Germany

Status

Recruiting

Address

Uniklinik Köln ( Site 1511)

Cologne, Nordrhein-Westfalen, 50931

Site Contact

Study Coordinator

Trialsites@merck.com

+492214785860

Mainz, Rheinland-Pfalz, Germany

Status

Recruiting

Address

Universitaetsmedizin Johannes Gutenberg Universitaet Mainz ( Site 1515)

Mainz, Rheinland-Pfalz, 55131

Site Contact

Study Coordinator

Trialsites@merck.com

+496131170

Dresden, Sachsen, Germany

Status

Recruiting

Address

Universitätsklinikum Carl Gustav Carus an der TU Dresden. ( Site 1501)

Dresden, Sachsen, 01307

Site Contact

Study Coordinator

Trialsites@merck.com

+493514585089

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

Status

Recruiting

Address

DRK Kliniken Berlin Westend ( Site 1507)

Berlin, , 14050

Site Contact

Study Coordinator

Trialsites@merck.com

+49 3030354305

Ashdod, Israel

Status

Recruiting

Address

Assuta Ashdod Medical Center ( Site 1710)

Ashdod, , 7747629

Site Contact

Study Coordinator

Trialsites@merck.com

972532227937

Be'er Ya'akov, Israel

Status

Recruiting

Address

Shamir Medical Center Assaf Harofeh ( Site 1713)

Be'er Ya'akov, , 7030001

Site Contact

Study Coordinator

Trialsites@merck.com

+97289779999

Rambam Health Corp. ( Site 1716), Haifa, Israel

Status

Recruiting

Address

Rambam Health Corp. ( Site 1716)

Haifa, , 3109601

Site Contact

Study Coordinator

Trialsites@merck.com

+97248542181

Haifa, Israel

Status

Recruiting

Address

Lady Davis Carmel Medical Center ( Site 1705)

Haifa, , 3436212

Site Contact

Study Coordinator

Trialsites@merck.com

+97248342707

Holon, Israel

Status

Recruiting

Address

Edith Wolfson Medical Center ( Site 1717)

Holon, , 58100

Site Contact

Study Coordinator

Trialsites@merck.com

+97235011991

Shaare Zedek Medical Center ( Site 1715), Jerusalem, Israel

Status

Recruiting

Address

Shaare Zedek Medical Center ( Site 1715)

Jerusalem, , 91031

Site Contact

Study Coordinator

Trialsites@merck.com

972508685209

Jerusalem, Israel

Status

Recruiting

Address

Hadassah Ein Kerem Medical Center ( Site 1711)

Jerusalem, , 9574425

Site Contact

Study Coordinator

Trialsites@merck.com

+97226777595

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

Status

Recruiting

Address

Meir Medical Center ( Site 1707)

Kfar Saba, , 4428164

Site Contact

Study Coordinator

Trialsites@merck.com

+97297471034

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

Status

Recruiting

Address

Rabin Medical Center ( Site 1703)

Petah Tiqwa, , 4941492

Site Contact

Study Coordinator

Trialsites@merck.com

+97239376751

Kaplan Medical Center ( Site 1712), Rehovot, Israel

Status

Recruiting

Address

Kaplan Medical Center ( Site 1712)

Rehovot, , 7610001

Site Contact

Study Coordinator

Trialsites@merck.com

+97289440040

ZIV Medical Center ( Site 1704), Safed, Israel

Status

Recruiting

Address

ZIV Medical Center ( Site 1704)

Safed, , 13100

Site Contact

Study Coordinator

Trialsites@merck.com

+97246828943

Tel Aviv, Israel

Status

Recruiting

Address

Tel Aviv Sourasky Medical Center ( Site 1714)

Tel Aviv, , 64239

Site Contact

Study Coordinator

Trialsites@merck.com

+97236973776

Bologna, Emilia-Romagna, Italy

Status

Recruiting

Address

AOU di Bologna Policlinico S Orsola Malpighi ( Site 2409)

Bologna, Emilia-Romagna, 40138

Site Contact

Study Coordinator

Trialsites@merck.com

+39051453104

Trieste, Friuli-Venezia Giulia, Italy

Status

Recruiting

Address

Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) ( Site 2405)

Trieste, Friuli-Venezia Giulia, 34149

Site Contact

Study Coordinator

Trialsites@merck.com

39 040 399 1111

Monza, Lombardia, Italy

Status

Recruiting

Address

Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza - A. O. San Gerardo ( Site 2406)

Monza, Lombardia, 20900

Site Contact

Study Coordinator

Trialsites@merck.com

+3903923311

Pavia, Lombardia, Italy

Status

Recruiting

Address

Fondazione IRCCS-Policlinico San Matteo ( Site 2401)

Pavia, Lombardia, 27100

Site Contact

Study Coordinator

Trialsites@merck.com

+390382503777

Ospedale SS Annunziata ( Site 2408), Sassari, Sardegna, Italy

Status

Recruiting

Address

Ospedale SS Annunziata ( Site 2408)

Sassari, Sardegna, 07100

Site Contact

Study Coordinator

Trialsites@merck.com

079 2061531939

ASST Papa Giovanni XXIII ( Site 2410), Bergamo, Italy

Status

Recruiting

Address

ASST Papa Giovanni XXIII ( Site 2410)

Bergamo, , 24127

Site Contact

Study Coordinator

Trialsites@merck.com

+390352675027

Roma, Italy

Status

Recruiting

Address

Azienda Policlinico Umberto I ( Site 2402)

Roma, , 00161

Site Contact

Study Coordinator

Trialsites@merck.com

+390649970382

Lubin, Lubelskie, Poland

Status

Recruiting

Address

Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego ( Site 2806)

Lubin, Lubelskie, 20-718

Site Contact

Study Coordinator

Trialsites@merck.com

+48815374556

Krakow, Malopolskie, Poland

Status

Recruiting

Address

Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 2801)

Krakow, Malopolskie, 31-202

Site Contact

Study Coordinator

Trialsites@merck.com

+48126143501

Otwock, Mazowieckie, Poland

Status

Recruiting

Address

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

Otwock, Mazowieckie, 05-400

Site Contact

Study Coordinator

Trialsites@merck.com

+48227103010

Warszawa, Mazowieckie, Poland

Status

Recruiting

Address

Państwowy Instytut Medyczny MSWiA ( Site 2805)

Warszawa, Mazowieckie, 02-507

Site Contact

Study Coordinator

Trialsites@merck.com

+0048502133158

Bialystok, Podlaskie, Poland

Status

Recruiting

Address

Uniwersytecki Szpital Kliniczny w Bialymstoku - Marii Sklodowskiej-Curie 24A ( Site 2803)

Bialystok, Podlaskie, 15-276

Site Contact

Study Coordinator

Trialsites@merck.com

+48857409458

Szczecin, Zachodniopomorskie, Poland

Status

Recruiting

Address

Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie ( Site 2804)

Szczecin, Zachodniopomorskie, 70-111

Site Contact

Study Coordinator

Trialsites@merck.com

+48914661197

Majadahonda, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario Puerta de Hierro (Majadahonda) ( Site 1604)

Majadahonda, Madrid, 28222

Site Contact

Study Coordinator

Trialsites@merck.com

+34911917418

Barcelona, Spain

Status

Recruiting

Address

Hospital Clinic de Barcelona ( Site 1602)

Barcelona, , 08036

Site Contact

Study Coordinator

Trialsites@merck.com

+34932275786

Madrid, Spain

Status

Recruiting

Address

Hospital Universitario 12 de Octubre ( Site 1603)

Madrid, , 28041

Site Contact

Study Coordinator

Trialsites@merck.com

+34914692313

Sevilla, Spain

Status

Recruiting

Address

Hospital Universitario Virgen Macarena ( Site 1612)

Sevilla, , 41009

Site Contact

Study Coordinator

Trialsites@merck.com

+34600162109

Toledo, Spain

Status

Recruiting

Address

Hospital Universitario de Toledo ( Site 1607)

Toledo, , 41007

Site Contact

Study Coordinator

Trialsites@merck.com

+34600162109

Goteburg, Vastra Gotalands Lan, Sweden

Status

Recruiting

Address

Sahlgrenska Universitetssjukhuset ( Site 3201)

Goteburg, Vastra Gotalands Lan, 413 45

Site Contact

Study Coordinator

Trialsites@merck.com

+46313422929

London, London, City Of, United Kingdom

Status

Recruiting

Address

Imperial College Healthcare NHS Trust ( Site 1203)

London, London, City Of, W12 0HS

Site Contact

Study Coordinator

Trialsites@merck.com

020 3311 3311

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