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Dapagliflozin Tab

Phase 2

HFrEF | Small molecule | Other |Amgen Inc.|Last Updated: Dec 12, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment3

FDA Designations

No designations recorded

Clinical trial landscape

Dapagliflozin Tab · 1 trial · 1 indication

Phase 2 1
NCT04956809Effect of Dapagliflozin on Submaximal Exercise Tolerance in Heart FailureHFrEF
COMPLETED3 Analytics
PHASE2COMPLETED
Effect of Dapagliflozin on Submaximal Exercise Tolerance in Heart Failure
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Study Endpoints

Primary Endpoints

The primary endpoint will be the change in submaximal exercise endurance (time to exhaustion at 75% of peak workload) between Dapa and placebo.
24 Months
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dapagliflozin 10mgACTIVE_COMPARATORActive arm will be 6 weeks in duration, separated by a 2-week wash-out period.
PlaceboPLACEBO_COMPARATORPlacebo arm will be 6 weeks in duration, separated by a 2-week wash-out period.

Interventions

NameTypeDescription
Dapagliflozin 10Mg TabDRUGThis will be a single-center randomized, placebo controlled, double-blind, 2-treatment, 2-phase cross-over trial in 27 HFrEF subjects: (A) Dapa 10 mg daily; (B) Placebo.
PlaceboDRUGThis will be a single-center randomized, placebo controlled, double-blind, 2-treatment, 2-phase cross-over trial in 27 HFrEF subjects: (A) Dapa 10 mg daily; (B) Placebo.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Diagnosis of HFrEF with NYHA Class II-III functional class, which has been present for at least two months 2. Left ventricular ejection fraction ≤ 40% 3. Stable medical therapy for at least 1 month 4. Plasma NT-proBNP level of: ≥ 200pg/mL; OR ≥ 125pg/mL if they were hospitali...

Countries:United States
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Frequently asked questions about Dapagliflozin Tab

What is Dapagliflozin Tab used for in HFrEF?

Dapagliflozin Tab is a small molecule being studied for the treatment of heart failure with reduced ejection fraction (HFrEF). It is currently in Phase 2 clinical development. The drug is being developed by Amgen Inc. (NASDAQ: AMGN).

How does Dapagliflozin Tab work?

Dapagliflozin Tab is a small molecule. The specific molecular target for Dapagliflozin Tab has not been disclosed in the available information. It is being investigated for its effects on submaximal exercise tolerance in patients with heart failure with reduced ejection fraction (HFrEF).

Who makes Dapagliflozin Tab?

Dapagliflozin Tab is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol AMGN. The drug is currently in Phase 2 clinical development for heart failure with reduced ejection fraction (HFrEF).

What phase is Dapagliflozin Tab in?

Dapagliflozin Tab is in Phase 2 clinical development. It is an investigational drug being studied for heart failure with reduced ejection fraction (HFrEF). It has not been approved by regulatory authorities and remains in clinical trials.

What clinical trials is Dapagliflozin Tab in?

Dapagliflozin Tab has one completed Phase 2 clinical trial, identified as NCT04956809, titled "Effect of Dapagliflozin on Submaximal Exercise Tolerance in Heart Failure." The trial enrolled 3 participants in the United States and was a randomized, double-blind, placebo-controlled study.

Is Dapagliflozin Tab the same as dapagliflozin?

Dapagliflozin Tab is a formulation of dapagliflozin, a small molecule drug. It is being developed by Amgen Inc. for heart failure with reduced ejection fraction (HFrEF). The drug is currently in Phase 2 clinical development and is not yet approved.