Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) (AURORA-HFpEF)

May 6, 2026 updated by: Bristol-Myers Squibb

A Phase 2A, Double-blind, Randomized, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)

The purpose of this study is to evaluate the safety, tolerability, and exposure-response (E-R) of BMS-986435/MYK-224 in participants with symptomatic Heart Failure with Preserved Ejection Fraction (HFpEF).

Study Overview

Status

Recruiting

Conditions

Heart Failure

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

208

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Phone Number: 855-907-3286
Email: Clinical.Trials@bms.com

Study Locations

Argentina
- - Buenos Aires, Argentina, 1407
    - Recruiting
    - Centro de Especialidades Médicas CEMEDIC
    - Contact:
      
      Claudio Majul, Site 0060
      
      Phone Number: +541146305763
  - Buenos Aires, Argentina, C1179AAB
    - Withdrawn
    - Local Institution - 0068
  - Buenos Aires, Argentina, C1431FWO
    - Not yet recruiting
    - Local Institution - 0067
    - Contact:
      
      Site 0067
  - Córdoba, Argentina, X5000AOQ
    - Recruiting
    - Sanatorio Duarte Quirós
    - Contact:
      
      Hugo Colombo, Site 0074
      
      Phone Number: +543514891398
  - Salta, Argentina, A4406BPF
    - Not yet recruiting
    - Local Institution - 0069
    - Contact:
      
      Site 0069
  - Santa Fe, Argentina, S3000FWO
    - Recruiting
    - Centro de Investigaciones Clínicas Del Litoral SRL
    - Contact:
      
      Miguel Hominal, Site 0102
      
      Phone Number: +5493426126156
- Buenos Aires
  - Ciudad del Libertador General San Martin, Buenos Aires, Argentina, B1650BNB
    - Recruiting
    - Corporación Médica de General San Martín
    - Contact:
      
      Rodolfo Ahuad Guerrero, Site 0054
      
      Phone Number: 541147547561
  - Zárate, Buenos Aires, Argentina, B2800DGH
    - Withdrawn
    - Local Institution - 0107
  - Zárate, Buenos Aires, Argentina, B2800DGH
    - Not yet recruiting
    - Local Institution - 0115
    - Contact:
      
      Site 0115
- Córdoba Province
  - Córdoba, Córdoba Province, Argentina, X5003DCE
    - Not yet recruiting
    - Local Institution - 0053
    - Contact:
      
      Site 0053
  - Córdoba, Córdoba Province, Argentina, 5000
    - Not yet recruiting
    - Local Institution - 0090
    - Contact:
      
      Site 0090
- Santa Fe Province
  - Rosario, Santa Fe Province, Argentina, 2000
    - Not yet recruiting
    - Local Institution - 0073
    - Contact:
      
      Site 0073
- Tucumán Province
  - San Miguel de Tucumán, Tucumán Province, Argentina, T4000IAP
    - Recruiting
    - IPR-Investigaciones en Patologías Respiratorias
    - Contact:
      
      Lilia Luz Lobo Marquez, Site 0061
      
      Phone Number: +548888888888
Canada
- Ontario
  - Hamilton, Ontario, Canada, L8L 2X2
    - Recruiting
    - Hamilton General Hospital
    - Contact:
      
      Catherine Demers, Site 0007
  - Toronto, Ontario, Canada, M4P 1E4
    - Recruiting
    - Medicus MFC Inc.
    - Contact:
      
      Gordon Moe, Site 0037
      
      Phone Number: 4168645319
  - Toronto, Ontario, Canada, M5S 1B2
    - Withdrawn
    - Local Institution - 0040
  - Toronto, Ontario, Canada, M5S 1B2
    - Withdrawn
    - Local Institution - 0030
- Quebec
  - Montreal, Quebec, Canada, H1T 1C8
    - Withdrawn
    - Local Institution - 0011
  - Trois-Rivières, Quebec, Canada, G9A 1Y1
    - Withdrawn
    - Local Institution - 0035
China
- Beijing Municipality
  - Beijing, Beijing Municipality, China, 100730
    - Recruiting
    - Peking Union Medical College Hospital - East Campus
    - Contact:
      
      Zhuang Tian, Site 0089
- Guangdong
  - Guangzhou, Guangdong, China, 510120
    - Recruiting
    - Guangdong Provincial People's Hospital
    - Contact:
      
      Zhicheng Jing, Site 0087
      
      Phone Number: +861390192726
- Henan
  - Luoyang, Henan, China, 471003
    - Recruiting
    - The First Affiliated Hospital of Henan Science and Technology University - Jinghua Campus
    - Contact:
      
      Laijing Du, Site 0080
      
      Phone Number: +861378311882
- Hunan
  - Changsha, Hunan, China, 410011
    - Recruiting
    - The Second Xiangya Hospital Of Central South University
    - Contact:
      
      Daoquan Peng, Site 0079
      
      Phone Number: +867318529530
- Zhejiang
  - Hangzhou, Zhejiang, China, 310009
    - Recruiting
    - The Second Affiliated Hospital, Zhejiang University School of Medicine - Jiefanglu Campus
    - Contact:
      
      JianAn Wang, Site 0082
      
      Phone Number: +865718731500
Israel
- - Beersheba, Israel, 84101
    - Not yet recruiting
    - Local Institution - 0111
    - Contact:
      
      Site 0111
  - Be’er Ya‘aqov, Israel, 7033001
    - Not yet recruiting
    - Local Institution - 0112
    - Contact:
      
      Site 0112
  - Haifa, Israel, 3109601
    - Not yet recruiting
    - Local Institution - 0108
    - Contact:
      
      Site 0108
  - Petah Tikva, Israel, 49100
    - Not yet recruiting
    - Local Institution - 0110
    - Contact:
      
      Site 0110
  - Rehovot, Israel, 76100
    - Not yet recruiting
    - Local Institution - 0106
    - Contact:
      
      Site 0106
  - Safed, Israel, 1311001
    - Recruiting
    - Ziv Medical Center
    - Contact:
      
      Majdi Halabi, Site 0116
      
      Phone Number: +97246828976
- Jerusalem
  - Jerusalem, Jerusalem, Israel, 90000
    - Not yet recruiting
    - Local Institution - 0109
    - Contact:
      
      Site 0109
  - Jerusalem, Jerusalem, Israel, 9103102
    - Not yet recruiting
    - Local Institution - 0113
    - Contact:
      
      Site 0113
Italy
- - Bergamo, Italy, 24127
    - Completed
    - Local Institution - 0009
  - Pisa, Italy, 56124
    - Completed
    - Local Institution - 0017
- Apulia
  - Foggia, Apulia, Italy, 71100
    - Withdrawn
    - Local Institution - 0027
  - Foggia, Apulia, Italy, 71100
    - Withdrawn
    - Local Institution - 0038
- Campania
  - Naples, Campania, Italy, 80131
    - Completed
    - Local Institution - 0019
- Lombardy
  - Milan, Lombardy, Italy, 20162
    - Withdrawn
    - Local Institution - 0023
  - Milan, Lombardy, Italy, 20162
    - Withdrawn
    - Local Institution - 0033
  - San Donato Milanese, Lombardy, Italy, 20097
    - Recruiting
    - IRCCS Policlinico San Donato
    - Contact:
      
      Massimo Piepoli, Site 0022
      
      Phone Number: 3902527749
  - San Donato Milanese, Lombardy, Italy, 20097
    - Withdrawn
    - Local Institution - 0050
- Tuscany
  - Massa, Tuscany, Italy, 54100
    - Withdrawn
    - Local Institution - 0052
Japan
- Hyōgo
  - Himeji-Shi, Hyōgo, Japan, 672-8044
    - Recruiting
    - Hyogo Prefectural Harima-Himeji General Medical Center
    - Contact:
      
      Tomofumi Takaya, Site 0092
      
      Phone Number: +81792895080
- Ishikawa-ken
  - Kanazawa, Ishikawa-ken, Japan, 920-8650
    - Recruiting
    - National Hospital Organization Kanazawa Medical Center
    - Contact:
      
      Takahiro Saeki, Site 0100
      
      Phone Number: 81762624161
- Okayama-ken
  - Okayama, Okayama-ken, Japan, 702-8055
    - Recruiting
    - Okayama Rosai Hospital
    - Contact:
      
      Mitsuru Munemasa, Site 0091
      
      Phone Number: +81862949911
- Osaka
  - Kishiwada, Osaka, Japan, 596-0042
    - Recruiting
    - Kishiwada Tokushukai Hospital
    - Contact:
      
      Satoshi Kuroyanagi, Site 0093
      
      Phone Number: 81724459915
  - Takatsuki-Shi, Osaka, Japan, 569-1045
    - Recruiting
    - Takatsuki Red Cross Hospital
    - Contact:
      
      Haruhiko Onaka, Site 0103
      
      Phone Number: +81726960571
Poland
- - Krakow, Poland, 30-082
    - Withdrawn
    - Local Institution - 0006
  - Oświęcim, Poland, 51162
    - Withdrawn
    - Local Institution - 0024
- Lódzkie
  - Lódz, Lódzkie, Poland, 92-213
    - Recruiting
    - Clinical Trials UMED Sp. z o.o.
    - Contact:
      
      Jaroslaw Drozdz, Site 0013
      
      Phone Number: +48426364471
- Podlaskie Voivodeship
  - Bialystok, Podlaskie Voivodeship, Poland, 15-276
    - Completed
    - Local Institution - 0031
  - Bialystok, Podlaskie Voivodeship, Poland, 15-276
    - Withdrawn
    - Local Institution - 0044
- Woj. Lubelskie
  - Lublin, Woj. Lubelskie, Poland, 20090
    - Withdrawn
    - Local Institution - 0049
  - Lublin, Woj. Lubelskie, Poland, 20090
    - Withdrawn
    - Local Institution - 0020
South Korea
- - Busan, South Korea, 49241
    - Recruiting
    - Pusan National University Hospital
    - Contact:
      
      Jung-Hyun Choi, Site 0086
      
      Phone Number: +8251254312700000000
  - Daegu, South Korea, 42601
    - Recruiting
    - Keimyung University Dongsan Hospital
    - Contact:
      
      Incheol Kim, Site 0088
      
      Phone Number: +828888888888
  - Gwangju, South Korea, 61469
    - Recruiting
    - Chonnam National University Hospital
    - Contact:
      
      Kye Hun Kim, Site 0083
      
      Phone Number: +82622206266
  - Seongnam-si, South Korea
    - Recruiting
    - Seoul National University Bundang Hospital
    - Contact:
      
      Goo-Yeong Cho, Site 0098
      
      Phone Number: 82317877024
  - Seoul, South Korea, 6351
    - Recruiting
    - Samsung Medical Center
    - Contact:
      
      Sang-Chol Lee, Site 0114
      
      Phone Number: 82-10-9933-3868
- Daejeon Gwang'yeogsi
  - Daejeon, Daejeon Gwang'yeogsi, South Korea, 35015
    - Recruiting
    - Chungnam National University Hospital
    - Contact:
      
      Jae-Hyeong Park, Site 0084
      
      Phone Number: +82422807167
- Incheon Gwang'yeogsi
  - Junggu, Incheon Gwang'yeogsi, South Korea, 22332
    - Recruiting
    - Inha University Hospital
    - Contact:
      
      Sung-Hee Shin, Site 0056
      
      Phone Number: +82328902440
- Seoul Teugbyeolsi
  - Seoul, Seoul Teugbyeolsi, South Korea, 3080
    - Recruiting
    - Seoul National University Hospital
    - Contact:
      
      Hyung-Kwan Kim, Site 0081
  - Seoul, Seoul Teugbyeolsi, South Korea, 03722
    - Recruiting
    - Severance Hospital Yonsei University Health System
    - Contact:
      
      Seok-Min Kang, Site 0085
      
      Phone Number: +820222277732
  - Seoul, Seoul Teugbyeolsi, South Korea, 06591
    - Recruiting
    - The Catholic University of Korea, Seoul St. Mary's Hospital
    - Contact:
      
      Jong-Chan Youn, Site 0055
      
      Phone Number: +828888888888
Spain
- - Madrid, Spain, 28034
    - Withdrawn
    - Local Institution - 0034
  - Madrid, Spain, 28034
    - Completed
    - Local Institution - 0026
  - Málaga, Spain, 29010
    - Active, not recruiting
    - Local Institution - 0032
  - Seville, Spain, 41014
    - Recruiting
    - Hospital Nuestra Señora de Valme
    - Contact:
      
      Antonio Reyes Dominguez, Site 0018
      
      Phone Number: 34955015777
  - Seville, Spain, 41014
    - Withdrawn
    - Local Institution - 0046
  - Valencia, Spain, 46010
    - Completed
    - Local Institution - 0010
- Barcelona
  - L'Hospitalet de Llobregat, Barcelona, Spain, 08907
    - Completed
    - Local Institution - 0012
- Madrid
  - Majadahonda, Madrid, Spain, 28222
    - Withdrawn
    - Local Institution - 0047
  - Majadahonda, Madrid, Spain, 28222
    - Completed
    - Local Institution - 0025
- Murcia
  - El Palmar, Murcia, Spain, 30120
    - Recruiting
    - Hospital Universitario Virgen de la Arrixaca
    - Contact:
      
      Domingo Pascual-Figal, Site 0021
      
      Phone Number: +34968369662
  - El Palmar, Murcia, Spain, 30120
    - Withdrawn
    - Local Institution - 0039
- Málaga
  - Málaga, Málaga, Spain, 29010
    - Withdrawn
    - Local Institution - 0042
United Kingdom
- - Bristol, United Kingdom, BS2 8HW
    - Recruiting
    - Bristol Royal Infirmary
    - Contact:
      
      Eva Sammut, Site 0101
      
      Phone Number: +448888888888
  - Dundee, United Kingdom, DD1 9SY
    - Not yet recruiting
    - Local Institution - 0097
    - Contact:
      
      Site 0097
  - London, United Kingdom, SE1 7EH
    - Not yet recruiting
    - Local Institution - 0075
    - Contact:
      
      Site 0075
  - Oxford, United Kingdom, OX3 9DU
    - Recruiting
    - John Radcliffe Hospital
    - Contact:
      
      Andrew Lewis, Site 0062
      
      Phone Number: 441865234657
  - Stockton-on-Tees, United Kingdom, TS19 8PE
    - Recruiting
    - University Hospital of North Tees
    - Contact:
      
      Paul Davison, Site 0065
      
      Phone Number: +1642624195
  - Wolverhampton, United Kingdom, WV10 0QP
    - Recruiting
    - New Cross Hospital
    - Contact:
      
      Sandeep Hothi, Site 0064
      
      Phone Number: +1902307999
- Greater London
  - Harrow, Greater London, United Kingdom, HA1 3UJ
    - Recruiting
    - Northwick Park Hospital
    - Contact:
      
      Jaymin Shah, Site 0063
      
      Phone Number: 0000000000
- Northumberland
  - North Shields, Northumberland, United Kingdom, NE29 8NH
    - Recruiting
    - North Tyneside General Hospital
    - Contact:
      
      Thomas Green, Site 0071
      
      Phone Number: +440191293408
- Yorkshire
  - Leeds, Yorkshire, United Kingdom, LS1 3EX
    - Recruiting
    - Leeds General Infirmary - PPDS
    - Contact:
      
      Andrew Walker, Site 0072
      
      Phone Number: +1133922385
  - Sheffield, Yorkshire, United Kingdom, S5 7AU
    - Withdrawn
    - Local Institution - 0057
United States
- Alabama
  - Birmingham, Alabama, United States, 35233
    - Recruiting
    - University of Alabama at Birmingham
    - Contact:
      
      Pankaj Arora, Site 0002
- Colorado
  - Lakewood, Colorado, United States, 80228-1710
    - Recruiting
    - Colorado Heart and Vascular - Lakewood
    - Contact:
      
      McHale Anderson, Site 0096
      
      Phone Number: 303-595-2619
- Florida
  - Jacksonville, Florida, United States, 32204-4748
    - Recruiting
    - Ascension St. Vincent's Riverside Hospital - PPDS
    - Contact:
      
      Nima Taghipour, Site 0077
      
      Phone Number: 888-888-8888
  - Miami, Florida, United States, 33133-4223
    - Active, not recruiting
    - Local Institution - 0003
  - Miami, Florida, United States, 33136-2107
    - Recruiting
    - University of Miami FL Miller School of Medicine -1120 NW 14th St
    - Contact:
      
      Omar Wever-Pinzon, Site 0099
- Georgia
  - Atlanta, Georgia, United States, 30322-1013
    - Withdrawn
    - Local Institution - 0048
  - Atlanta, Georgia, United States, 30322-1013
    - Withdrawn
    - Local Institution - 0014
- Illinois
  - Chicago, Illinois, United States, 60611-5969
    - Recruiting
    - Bluhm Cardiovascular Institute of Northwestern
    - Contact:
      
      Ravi Patel, Site 0004
  - Hazel Crest, Illinois, United States, 60429-2196
    - Recruiting
    - Chicago Medical Research, LLC - Hazel Crest
    - Contact:
      
      Suhail Khadra, Site 0005
      
      Phone Number: 708-798-8522
- Indiana
  - Indianapolis, Indiana, United States, 46260-1992
    - Withdrawn
    - Local Institution - 0045
  - Indianapolis, Indiana, United States, 46260-1992
    - Recruiting
    - Ascension Medical Group St. Vincent - Indianapolis Heart Care
    - Contact:
      
      Ashwin Ravichandran, Site 0029
- Missouri
  - St Louis, Missouri, United States, 63136-6111
    - Recruiting
    - St. Louis Heart and Vascular
    - Contact:
      
      Harvey Serota, Site 0028
      
      Phone Number: 314-741-0911
  - St Louis, Missouri, United States, 63136
    - Withdrawn
    - Local Institution - 0043
- New Jersey
  - Hackensack, New Jersey, United States, 07601-1915
    - Not yet recruiting
    - Local Institution - 0117
    - Contact:
      
      Site 0117
- New York
  - Albany, New York, United States, 12211
    - Recruiting
    - Capital Cardiology Associates
    - Contact:
      
      Eugene Pashkovetsky, Site 0070
      
      Phone Number: 347-200-1755
  - Brooklyn, New York, United States, 11215
    - Not yet recruiting
    - Local Institution - 0105
    - Contact:
      
      Site 0105
  - New York, New York, United States, 10065-4805
    - Recruiting
    - Weill Cornell Medicine
    - Contact:
      
      Parag Goyal, Site 0008
  - Rochester, New York, United States, 14618-2668
    - Recruiting
    - University of Rochester Medical Center - PPDS
    - Contact:
      
      Christopher Cove, Site 0059
      
      Phone Number: 585-341-7800
  - Rochester, New York, United States, 14621
    - Recruiting
    - Rochester General Hospital Center for Clinical Research
    - Contact:
      
      Vishal Parikh, Site 0076
      
      Phone Number: 585-922-3536
  - Rosedale, New York, United States, 11422-1320
    - Recruiting
    - Laurelton Heart Specialist PC - MyClinical - PPDS
    - Contact:
      
      Olakunle Akinboboye, Site 0094
      
      Phone Number: 718-949-9400
- North Carolina
  - Durham, North Carolina, United States, 27710-4000
    - Recruiting
    - Duke Cardiology Clinic - PPDS
    - Contact:
      
      Marat Fudim, Site 0095
      
      Phone Number: 917-544-4377
- Ohio
  - Cincinnati, Ohio, United States, 45242
    - Withdrawn
    - Local Institution - 0058
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73135-2607
    - Withdrawn
    - Local Institution - 0041
  - Oklahoma City, Oklahoma, United States, 73135-2607
    - Recruiting
    - South Oklahoma Heart Research
    - Contact:
      
      Naeem Tahirkheli, Site 0016
      
      Phone Number: 405-628-6865
- Pennsylvania
  - Abington, Pennsylvania, United States, 19001
    - Recruiting
    - Abington Memorial Hospital
    - Contact:
      
      Donald Haas, Site 0078
      
      Phone Number: 215-481-4199
- Tennessee
  - Tullahoma, Tennessee, United States, 37388-8260
    - Recruiting
    - Tennessee Center For Clinical Trials
    - Contact:
      
      Dinesh Gupta, Site 0001
      
      Phone Number: 931-461-2663
- Texas
  - Austin, Texas, United States, 78756-4080
    - Not yet recruiting
    - Local Institution - 0104
    - Contact:
      
      Site 0104
  - Dallas, Texas, United States, 75390
    - Recruiting
    - University of Texas Southwestern Medical Center
    - Contact:
      
      Ambarish Pandey, Site 0036
      
      Phone Number: 214-645-8000
  - Houston, Texas, United States, 77025-5253
    - Withdrawn
    - Local Institution - 0051
  - Houston, Texas, United States, 77025-5253
    - Recruiting
    - Angiocardiac Care of Texas - PA - PPDS
    - Contact:
      
      Amin Karim, Site 0015
      
      Phone Number: 832-885-7723
- Virginia
  - Falls Church, Virginia, United States, 22042-1262
    - Withdrawn
    - Local Institution - 0066

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria

- Adult participants with stable, symptomatic HFpEF with a normal heart pumping ability.

Exclusion Criteria

Participants must not have a known diagnosis of obstructive or genetic hypertrophic cardiomyopathy or infiltrative/storage disorder such as cardiac amyloidosis, or any other acute or serious condition that could interfere with assessments during the study or may pose a risk to the participant.
Other protocol-defined Inclusion/Exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Sequential Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo Specified dose on specified days
Experimental: BMS-986435	Drug: BMS-986435 Specified dose on specified days Other Names: MYK-224

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of treatment emergent adverse events (TEAEs) Time Frame: Up to approximately 24 weeks	Up to approximately 24 weeks
Incidence of serious adverse events (SAEs) Time Frame: Up to approximately 24 weeks	Up to approximately 24 weeks
Incidence of AEs leading to treatment discontinuation Time Frame: Up to approximately 20 weeks	Up to approximately 20 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Summary of plasma concentrations of MYK-224 Time Frame: Up to approximately 20 weeks	Up to approximately 20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2023

Primary Completion (Estimated)

July 3, 2026

Study Completion (Estimated)

July 3, 2026

Study Registration Dates

First Submitted

November 3, 2023

First Submitted That Met QC Criteria

November 3, 2023

First Posted (Actual)

November 8, 2023

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CV029-1001
2023-505919-21 (EudraCT Number)
U1111-1292-8451 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP
CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Urine Sodium-Driven Diuretic Adjustment Strategy in Acute Decompensated Heart Failure (US-DASH)

Heart Failure | Heart Failure Acute | Acute Heart Failure (AHF) | Heart Failure - NYHA II - IV

United States
VA Eastern Colorado Health Care System
National Institute on Aging (NIA)

Completed

Balance, Aerobic Capacity, Mobility and Strength in Patients Hospitalized for Heart Failure (BAMS-HF) Program (BAMS-HF)

Heart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure; With Decompensation | Heart Failure，Congestive | Heart Failure Acute

United States
Eli Lilly and Company

Not yet recruiting

A Study of LY3971297 in Participants With Heart Failure

Heart Failure | Heart Failure, Diastolic | Heart Failure, Systolic

United States, Japan
Wake Forest University
National Institute on Aging (NIA)

Completed

PIE II: Pharmacological Intervention in the Elderly II

Heart Failure, Congestive | Diastolic Heart Failure

United States

Clinical Trials on Placebo

Galderma R&D

Completed

Effect of CD07805/47 Gel in Rosacea Flushing

Rosacea

Germany
SamA Pharmaceutical Co., Ltd

Unknown

Clinical Trials to Assess the Efficacy and Safety of HLIM

Acute Bronchitis | Acute Upper Respiratory Tract Infection

Korea, Republic of
National Institute on Drug Abuse (NIDA)

Completed

Effects of Cannabis Administration Routes on Human Performance and Pharmacokinetics

Cannabis Use

United States
Akeso

Not yet recruiting

A Clinical Study of AK120 in Adolescents With Moderate-to-severe Atopic Dermatitis

Atopic Dermatitis

China
AstraZeneca
Parexel; Spandauer Damm 130; 14050; Berlin, Germany

Completed

Assessment of the Safety, Tolerability and Pharmacodynamics After Administration of One Dose of AZD8601 to Male Patients With Type II Diabetes Mellitus (T2DM)

Male Subjects With Type II Diabetes (T2DM)

Germany
Heptares Therapeutics Limited

Completed

Pharmacokinetics of Oral Capsule in Healthy Japanese vs. Caucasian Subjects (HTL0018318)

Pharmacokinetics | Safety Issues

United Kingdom
GlaxoSmithKline

Completed

A Clinical Study Assessing Critical Errors, Training/Teaching Time, and Preference Attributes of the ELLIPTA® Dry Powder Inhaler, in Comparison to Combinations of Dry Powder Inhalers Used to Provide Triple Therapy, in Patients With Chronic Obstructive Pulmonary Disease

Pulmonary Disease, Chronic Obstructive

United Kingdom, Netherlands
Shijiazhuang Yiling Pharmaceutical Co. Ltd
Xuanwu Hospital, Beijing

Completed

Study on the Safety, Tolerance and Pharmacokinetics of Phenlarmide Tablets

Parkinson Disease

China
GlaxoSmithKline

Completed

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Oral and Intravenous GSK1322322 in Healthy Subjects

Infections, Bacterial

United States
Chong Kun Dang Pharmaceutical

Unknown

Clinical Study to Evaluate the Efficacy and Safety of CKD-348(CKD-828, D326, D337) Tablet

Hypertension | Dyslipidemias

Korea, Republic of

Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) (AURORA-HFpEF)

A Phase 2A, Double-blind, Randomized, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)

Study Overview

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Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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Clinical Trials on Placebo

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