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BAY 1753011

Phase 2

Heart Failure (HF) | Small molecule | Cardiovascular |Bayer AG|Last Updated: Apr 18, 2022

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment482

FDA Designations

No designations recorded

Clinical trial landscape

BAY 1753011 · 1 trial · 1 indication

Phase 2 1
NCT03901729A Trial to Study BAY1753011 in Patients With Congestive Heart FailureHeart Failure (HF)
COMPLETED482 Analytics
PHASE2COMPLETED
A Trial to Study BAY1753011 in Patients With Congestive Heart Failure
Heart Failure (HF)Unlock trial analytics

Study Endpoints

Primary Endpoints

PART A: Change in body weight
Compare Day 30 (End of part A) with Day 1 (Start of part A)
PART A: Change in serum creatinine
Compare Day 30 (End of part A) with Day 1 (Start of part A)
PART B: Change in body weight
Compare Day 60 (End of part B) with Day 30 (Start of part B)
PART B: Change in log transformed blood urea nitrogen (BUN)/creatinine ratio
Compare Day 60 (End of part B) with Day 30 (Start of part B)

Secondary Endpoints

Incidence of Treatment-emergent adverse event (including Serious adverse event)
From the time of first study drug administration up to 7 days after the last dose of study drug (Day 60)
Change in augmentation index
Up to 60 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTALBAY1753011 30mg in addition to standard of care (SoC) for part A and part B
Arm 2PLACEBO_COMPARATORPlacebo of BAY1753011 in addition to SoC for part A and part B
Arm 1-AEXPERIMENTALBAY1753011 30mg in addition to Placebo Furosemide 80mg for part B
Arm 1-BACTIVE_COMPARATORFurosemide 80mg in addition to Placebo BAY1753011 30mg for part B
Arm 2-AEXPERIMENTALBAY1753011 30mg in addition to Placebo Furosemide 80mg for part B
Arm 2-BACTIVE_COMPARATORFurosemide 80mg in addition to Placebo BAY1753011 30mg for part B

Interventions

NameTypeDescription
BAY 1753011DRUGTablet; 30mg or 5mg unit; 30mg once daily in the morning; Oral
Placebo BAY 1753011OTHERTablet; Once daily in the morning; Oral
FurosemideDRUGTablet; 40mg unit; 80mg once daily in the morning; Oral
Placebo FurosemideOTHERTablet; Once daily in the morning; Oral
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Eligibility Criteria

Age Range18 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites66

Inclusion Criteria: * History of CHF on individually optimized treatment with HF medications unless contraindicated or not tolerated, for at least 12 weeks prior to index hospitalization and in accordance with international guidelines. * Subjects admitted to the hospital with a primary diagnosis of...

Countries:AustriaBulgariaGreeceHungaryIsraelItalyPolandPortugalSpain
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Frequently asked questions about BAY 1753011

What is BAY 1753011 used for?

BAY 1753011 is an investigational small molecule being developed for the treatment of Heart Failure (HF). It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with congestive heart failure.

Who makes BAY 1753011?

BAY 1753011 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded over-the-counter under the ticker symbol BAYRY. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for heart failure.

What phase is BAY 1753011 in?

BAY 1753011 is currently in Phase 2 clinical development. It is an investigational drug and has not received regulatory approval. The Phase 2 trial for BAY 1753011 has been completed, and the drug is being evaluated for the treatment of Heart Failure (HF).

What clinical trials is BAY 1753011 in?

BAY 1753011 has one completed Phase 2 clinical trial registered under NCT03901729, titled "A Trial to Study BAY1753011 in Patients With Congestive Heart Failure." This randomized, double-blind, placebo-controlled trial enrolled 482 participants across multiple countries including Austria, Bulgaria, Greece, Hungary, Israel, Italy, Poland, Portugal, and Spain.

Is BAY 1753011 FDA approved?

No, BAY 1753011 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for the treatment of Heart Failure (HF). The drug has not completed the clinical trial process required for regulatory approval and remains under investigation by Bayer AG.