Hypertrophic Cardiomyopathy Clinical Trial

A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy

Summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of mavacamten compared with placebo in participants with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Diagnosis of HCM consistent with current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines: unexplained left-ventricular hypertrophy with non-dilated ventricular chambers in the absence of other cardiac or systemic disease which can produce the required magnitude of hypertrophy of a maximal left ventricular (LV) wall thickness ≥ 15 millimeters (mm) (or ≥ 13 mm with positive family history of hypertrophic cardiomyopathy [HCM]) as determined by core laboratory interpretation
Peak left ventricular outflow tract (LVOT) pressure gradient < 30 millimeters mercury (mm Hg) at rest and < 50 mm Hg with provocation (Valsalva maneuver and stress echocardiography)
New York Heart Association (NYHA) Class II or III

Exclusion Criteria:

Known infiltrative or storage disorder causing cardiac hypertrophy that mimics non-obstructive hypertrophic cardiomyopathy (nHCM) such as Fabry disease, amyloidosis, or Noonan syndrome with LV hypertrophy
History of unexplained syncope within 6 months prior to screening
History of sustained ventricular tachyarrhythmia (> 30 seconds) within 6 months prior to screening

Additional inclusion and exclusion criteria apply.

Study is for people with:

Hypertrophic Cardiomyopathy

Phase:

Phase 3

Estimated Enrollment:

420

Study ID:

NCT05582395

Recruitment Status:

Recruiting

Sponsor:

Bristol-Myers Squibb

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There are 197 Locations for this study

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UAB Hospital Clinical Research Unit
Birmingham Alabama, 35233, United States More Info
Jose Tallaj, Site 0082
Contact
205-934-3438
Mayo Clinic Arizona - PPDS
Phoenix Arizona, 85054, United States More Info
Said Alsidawi, Site 0458
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Sulpizio Cardiovascular Center
La Jolla California, 92037, United States More Info
Eric Adler, Site 0409
Contact
858-246-2996
Cedars-Sinai Heart Institute
Los Angeles California, 90048, United States More Info
Florian Rader, Site 0010
Contact
310-967-3846
Stanford University
Palo Alto California, 94304, United States More Info
Matthew Wheeler, Site 0079
Contact
UCSF School of Medicine
San Francisco California, 94143, United States More Info
Theodore Abraham, Site 0406
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University of Florida
Gainesville Florida, 32610, United States More Info
Mohammad Al-Ani, Site 0468
Contact
352-273-9076
Usf Health South Tampa Center For Advanced Healthcare
Tampa Florida, 33606, United States More Info
Thomas McDonald, Site 0281
Contact
813-974-5413
Emory University Hospital
Atlanta Georgia, 30322, United States More Info
Ozlem Bilen, Site 0092
Contact
404-778-5299
Indiana University School of Medicine-Indianapolis
Indianapolis Indiana, 46202, United States More Info
Roopa Rao, Site 0424
Contact
317-962-9700
University of Iowa Hospitals And Clinics
Iowa City Iowa, 52242, United States More Info
Ernesto Ruiz Duque, Site 0070
Contact
319-353-5245
University of Kansas Medical Center
Kansas City Kansas, 66160, United States More Info
Loren Berenbom, Site 0410
Contact
+910771569
Norton Healthcare
Louisville Kentucky, 40217, United States More Info
Srikanth Seethala, Site 0484
Contact
972-835-2873
Johns Hopkins University
Baltimore Maryland, 21287, United States More Info
Jose Madrazo, Site 0127
Contact
410-955-8315
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Albree Tower-Rader, Site 0479
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617-724-5434
University of Michigan Comprehensive Cancer Center UMCCC-Gastrointestinal Cancer Clinic
Ann Arbor Michigan, 48109, United States More Info
Sara Saberi, Site 0464
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Henry Ford Hospital
Detroit Michigan, 48202, United States More Info
Karthikeyan Ananthasubramaniam, Site 0064
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Spectrum Health
Grand Rapids Michigan, 49525, United States More Info
David Fermin, Site 0455
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616-885-5000
Mayo Clinic - PPDS
Rochester Minnesota, 55905, United States More Info
Jeffrey B. Geske, Site 0431
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507-218-8044
Washington University School of Medicine
Saint Louis Missouri, 63110, United States More Info
Richard Bach, Site 0461
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314-362-1963
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States More Info
Douglas Stoller, Site 0435
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402-559-8888
North Shore University Hospital-300 Community Dr
Manhasset New York, 11030, United States More Info
Ronald Wharton, Site 0449
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516-562-3317
Stony Brook Heart Institute
Stony Brook New York, 11790, United States More Info
Michael Gavalas, Site 0007
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631-444-2031
Westchester Medical Center
Valhalla New York, 10595, United States More Info
Srihari Naidu, Site 0426
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914-493-7760
Carolinas Healthcare System
Charlotte North Carolina, 28402, United States More Info
John Symanski, Site 0094
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704-373-1503
Duke University Health System
Durham North Carolina, 27710, United States More Info
Andrew Wang, Site 0065
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Cleveland Clinic Ohio - 9500 Euclid Ave
Cleveland Ohio, 44195, United States More Info
Milind Desai, Site 0083
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216-445-5250
Oregon Health and Science University
Portland Oregon, 97239, United States More Info
Ahmad Masri, Site0084
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503-494-7551
St. Luke's University Health Network
Allentown Pennsylvania, 18104, United States More Info
Jamshid Shirani, Site 0020
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718-430-3314
Penn State Health Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States More Info
Eric Popjes, Site 0047
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717-531-1790
Lancaster General Hospital
Lancaster Pennsylvania, 17604, United States More Info
Robert Donovan, Site 0444
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412-613-7238
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States More Info
Anjali Owens, Site 0263
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University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15213, United States More Info
Timothy Wang, Site 0081
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Medical University of South Carolina - PPDS
Charleston South Carolina, 29425, United States More Info
Jessica Atkins, Site 0058
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843-792-0464
Stern Cardiovascular Center. Pa
Germantown Tennessee, 38138, United States More Info
Frank McGrew, Site 0207
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901-271-4066
Baylor Heart and Vascular Hospital
Dallas Texas, 75226, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States More Info
James MacNamara, Site 0365
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214-645-8000
University of Texam Houston Medical School
Houston Texas, 77030, United States More Info
Ali Marian, Site0002
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713-798-7454
Baylor Scott and White Research Institute
Temple Texas, 76508, United States More Info
Robert Gottlieb, Site 0089
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408-444-5823
University of Utah - PPDS
Salt Lake City Utah, 84132, United States More Info
Omar Wever-Pinzon, Site 0402
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801-581-7735
University of Virginia Health System
Charlottesville Virginia, 22908, United States More Info
Christopher Kramer, Site 0478
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434-982-0853
Virginia Commonwealth University Medical Center
Richmond Virginia, 23298, United States More Info
Mohammed Makkiya, Site 0095
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804-828-9989
University of Washington Medical Center
Seattle Washington, 98195, United States
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Concord New South Wales, 2139, Australia More Info
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Darlinghurst New South Wales, 2010, Australia More Info
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Wagga Wagga New South Wales, 2650, Australia More Info
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Milton Queensland, 4064, Australia More Info
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Murdoch Western Australia, 6150, Australia More Info
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Braunau am Inn Oberösterreich, 5280, Austria More Info
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Linz , 4020, Austria More Info
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Wien , 1090, Austria More Info
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Edegem Antwerpen, 2650, Belgium More Info
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Anderlecht Brussels, 1070, Belgium More Info
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Genk Limburg, 3600, Belgium More Info
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Leuven Vlaams Brabant, 3000, Belgium More Info
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Fortaleza Ceara, 60430, Brazil More Info
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Brasília Distrito Federal, 70710, Brazil More Info
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Goiânia Goias, 74223, Brazil More Info
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Rio De Janeiro , 20551, Brazil More Info
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Rio de Janeiro , 22061, Brazil More Info
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Brno Jihomoravský Kraj, 656 9, Czechia More Info
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Broumov Královéhradecký Kraj, 550 0, Czechia More Info
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Prague Praha, Hlavní Mesto, 140 0, Czechia More Info
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Praha 2 , 128 0, Czechia More Info
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Aalborg Nordjylland, 9000, Denmark More Info
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Aabenraa South Denmark, 6200, Denmark More Info
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Aarhus N , 8200, Denmark More Info
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Nice Alpes-Maritimes, 06000, France More Info
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Brest Finistère, 29200, France More Info
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Pessac Gironde, 33600, France More Info
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Toulouse Haute-Garonne, 31000, France More Info
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Boulogne-Billancourt Hauts-de-Seine, 92100, France More Info
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Chambray-lès-tours Indre-et-Loire, 37044, France More Info
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Bron Rhône, 69500, France More Info
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München Bayern, 81377, Germany More Info
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Regensburg Bayern, 93053, Germany More Info
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Würzburg Bayern, 97078, Germany
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Hannover Niedersachsen, 30625, Germany More Info
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Bad Oeynhausen Nordrhein-Westfalen, 32545, Germany More Info
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Bielefeld Nordrhein-Westfalen, 33604, Germany More Info
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Mainz Rheinland-Pfalz, 55131, Germany More Info
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Mainz Rhineland-Palatinate, 55131, Germany
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Kiel Schleswig-Holstein, 24105, Germany More Info
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Jena Thüringen, 07747, Germany More Info
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Berlin , 13353, Germany More Info
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Freiburg , 79106, Germany More Info
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Hamburg , 20246, Germany More Info
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Heidelberg , 69120, Germany More Info
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Köln , 50937, Germany More Info
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München , 80636, Germany More Info
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Münster , 48149, Germany More Info
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Ulm , 89081, Germany More Info
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Balatonfüred Veszprém, 8230, Hungary More Info
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Budapest , 1083, Hungary More Info
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Budapest , 1096, Hungary More Info
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Budapest , 1097, Hungary More Info
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Szeged , 6725, Hungary More Info
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Gurgaon Haryana, 12200, India More Info
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Bengaluru Karnataka, 56009, India More Info
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Kochi Kerala, 68200, India More Info
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Chandigarh , 16001, India More Info
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Jerusalem Yerushalayim, Bayer, Israel More Info
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Ashkelon , 78278, Israel More Info
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Haifa , 31096, Israel More Info
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Jerusalem , 91031, Israel More Info
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Petah Tikva , 49100, Israel More Info
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Ramat-Gan , 52621, Israel More Info
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Rehovot , 76100, Israel More Info
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Safed , 13100, Israel More Info
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Tel-Aviv , 64239, Israel More Info
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Roma Lazio, 00189, Italy More Info
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Pisa Toscana, 56124, Italy More Info
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Firenze , 50134, Italy More Info
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Uwajima Ehime, 798-8, Japan More Info
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Himeji-Shi Hyogo, 672-8, Japan More Info
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Kanazawa-shi Ishikawa, 920-8, Japan More Info
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Yokohama-Shi Aoba-Ku Kanagawa, 227-0, Japan More Info
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Nankoku-shi Kochi, 783-8, Japan More Info
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Tsu-Shi MIE, 514-0, Japan More Info
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Sendai-shi Miyagi, 980-8, Japan More Info
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Osaka-Shi Osaka, 545-0, Japan More Info
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Takatsuki-Shi Osaka, 569-8, Japan More Info
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Hamamatsu-Shi Shizuoka, 431-3, Japan More Info
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Bunkyo-ku Tokyo, 113-8, Japan More Info
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Itabashi-Ku Tokyo, 173-8, Japan More Info
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Koto-Ku Tokyo, 135-0, Japan More Info
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Shinjuku Tokyo, 16286, Japan More Info
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Shinjuku-Ku , 162-8, Japan More Info
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Tokyo , 113-8, Japan More Info
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Seoul Seoul Teugbyeolsi, 05505, Korea, Republic of More Info
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Seoul Seoul Teugbyeolsi, 06351, Korea, Republic of More Info
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Seoul , 03080, Korea, Republic of More Info
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Seoul , 03722, Korea, Republic of More Info
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Seoul , 06591, Korea, Republic of More Info
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Nijmegen Gelderland, 6525 , Netherlands More Info
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Rotterdam Zuid-Holland, 3015 , Netherlands More Info
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Maastricht , 6211 , Netherlands More Info
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Utrecht , 3584 , Netherlands More Info
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Lørenskog Akershus, N-147, Norway More Info
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Oslo , 0424, Norway More Info
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Trondheim , 7030, Norway More Info
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Wroclaw Dolnoslaskie, 50-98, Poland More Info
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Lodz Lodzkie, 91-34, Poland More Info
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Guimarães Braga, 4835-, Portugal More Info
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Almada , 2805-, Portugal More Info
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Leiria , 2410-, Portugal More Info
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Lisboa , 1500-, Portugal More Info
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Vila Nova de Gaia , 4434-, Portugal More Info
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L'hospitalet de Llobregat Barcelona, 08907, Spain More Info
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Majadahonda Madrid, 28222, Spain More Info
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Malaga Málaga, 29010, Spain More Info
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A Coruna , 15006, Spain More Info
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Alicante , 03010, Spain More Info
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Barcelona , 08035, Spain More Info
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Barcelona , 08036, Spain More Info
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Granada , 18014, Spain More Info
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Madrid , 28034, Spain More Info
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Murcia , 30120, Spain More Info
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Palma de Mallorca , 07198, Spain More Info
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Salamanca , 37007, Spain More Info
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Valencia , 46026, Spain More Info
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Glasgow Lanarkshire, G51 4, United Kingdom More Info
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How clear is this clinincal trial information?

Study is for people with:

Hypertrophic Cardiomyopathy

Phase:

Phase 3

Estimated Enrollment:

420

Study ID:

NCT05582395

Recruitment Status:

Recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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