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Milrinone

Phase 2

Valvular Stenosis | Small molecule | Cardiovascular |Stoke Therapeutics, Inc.|Last Updated: Oct 25, 2013

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment124

FDA Designations

No designations recorded

Clinical trial landscape

Milrinone · 1 trial · 4 indications

Phase 2 1
NCT00819377Milrinone Inhaled in Cardiac SurgeryValvular Stenosis
COMPLETED124 Analytics
PHASE2COMPLETED
Milrinone Inhaled in Cardiac Surgery
Valvular StenosisUnlock trial analytics

Study Endpoints

Primary Endpoints

To demonstrate that inhaled milrinone administered before CPB is superior to placebo in reducing the severity of difficult separation from bypass
End of CPB

Secondary Endpoints

Reduction in morbidity and mortality post-op
At discharge, 3 months, 6 months and 1 year by telephone
Reduction in pulmonary artery pressure
Same day before and after CPB
Right ventricular function measured using transthoracic echocardiography (TTE) and TEE
Same day before and after the CPB
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Normal salinePLACEBO_COMPARATORNormal saline by inhalation over 15 min
MilrinoneACTIVE_COMPARATORInhaled milrinone 5 mg(as for the injectable solution)

Interventions

NameTypeDescription
MilrinoneDRUGinhaled milrinone 5 mg (as for the injectable solution)
Normal salineDRUG5 ml normal saline by inhalation over 15 min
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Eligibility Criteria

Age Range18 Years to 90 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Adult patients scheduled for elective valvular or complex (2 or more valves or * valve and revascularization) cardiac surgery under CPB with preoperative PHT defined as mean pulmonary artery pressure (MPAP) over 30 mmHg or * systolic pulmonary artery pressure (SPAP) over 40 mm...

Countries:Canada
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Frequently asked questions about Milrinone

What is Milrinone used for in Valvular Stenosis?

Milrinone is a small molecule being studied for use in Valvular Stenosis, a condition involving narrowing of heart valves. It is also being investigated for related cardiovascular conditions including Valvular Insufficiency, Pulmonary Hypertension, and Coronary Artery Disease. The drug is currently in Phase 2 clinical development.

What does Milrinone target?

Milrinone is a small molecule that works as a phosphodiesterase inhibitor, specifically targeting phosphodiesterase 3 (PDE3). By inhibiting this enzyme, it increases intracellular cyclic AMP levels, leading to increased cardiac contractility and vasodilation. This mechanism is relevant to its use in cardiovascular conditions such as Valvular Stenosis.

Who makes Milrinone?

Milrinone is being developed by Stoke Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol STOK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in cardiovascular indications.

What phase is Milrinone in?

Milrinone is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied for its potential use in treating Valvular Stenosis and other cardiovascular conditions.

What clinical trials is Milrinone in?

Milrinone has one completed Phase 2 clinical trial registered as NCT00819377, titled "Milrinone Inhaled in Cardiac Surgery." This randomized, double-blind, placebo-controlled trial enrolled 124 participants in Canada and studied the drug in patients with Valvular Stenosis, Valvular Insufficiency, Pulmonary Hypertension, and Coronary Artery Disease.

Is Milrinone the same as any other drug?

Milrinone is also known by its brand name Primacor. It is a phosphodiesterase inhibitor used in the management of heart failure. In the context of this development program, it is being evaluated as an inhaled formulation for cardiac surgery patients with valvular and coronary artery conditions.