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EFI/ACT-385781A

Phase 3

Pulmonary Arterial Hypertension | Small molecule | Cardiovascular |Johnson & Johnson|Last Updated: Jan 13, 2015

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment42

FDA Designations

No designations recorded

Clinical trial landscape

EFI/ACT-385781A · 1 trial · 1 indication

Phase 3 1
NCT01431716Epoprostenol for Injection (EFI/ACT-385781A) - Pulmonary Arterial HypertensionPulmonary Arterial Hypertension
COMPLETED42 Analytics
PHASE3COMPLETED
Epoprostenol for Injection (EFI/ACT-385781A) - Pulmonary Arterial Hypertension
Pulmonary Arterial HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in Pulmonary Vascular Resistance From Baseline to End of Treatment (EOT).
Approximately 3 months

Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.

Change in Total Pulmonary Resistance From Baseline to End of Treatment (EOT).
Approximately 3 months

Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.

Change in Mean Pulmonary Arterial Pressure From Baseline to End of Treatment (EOT).
Approximately 3 months

Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.

Change in Mean Right Atrial Pressure From Baseline to End of Treatment (EOT).
Approximately 3 months

Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.

Change in Pulmonary Capillary Wedge Pressure From Baseline to End of Treatment (EOT).
Approximately 3 months

Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.

Change in Mean Cardiac Index From Baseline to End of Treatment (EOT).
Approximately 3 months

Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
EFI/ACT-385781AEXPERIMENTALEFI/ACT-385781 administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump

Interventions

NameTypeDescription
EFI/ACT-385781ADRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: 1. Male or female aged 18 years and above 2. Patients with the following types of pulmonary arterial hypertension (PAH) belonging to WHO Group I: Idiopathic (IPAH), Heritable (HPAH), Associated (APAH) with Connective tissue diseases or Drugs and toxins 3. Patients treated with F...

Countries:BelgiumCanadaFranceItalyNetherlandsSpain
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Frequently asked questions about EFI/ACT-385781A

What is EFI/ACT-385781A used for?

EFI/ACT-385781A is used for the treatment of pulmonary arterial hypertension (PAH), a type of high blood pressure affecting the arteries in the lungs and the right side of the heart. It is a small molecule developed by Johnson & Johnson and is intended to address this cardiovascular condition.

Who makes EFI/ACT-385781A?

EFI/ACT-385781A is developed by Johnson & Johnson, a multinational corporation traded on the New York Stock Exchange under the ticker symbol JNJ. The company is responsible for the clinical development of this investigational small molecule for pulmonary arterial hypertension.

What phase is EFI/ACT-385781A in?

EFI/ACT-385781A is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy in patients with pulmonary arterial hypertension.

What clinical trials is EFI/ACT-385781A in?

EFI/ACT-385781A has one completed Phase 3 clinical trial, identified as NCT01431716, titled 'Epoprostenol for Injection (EFI/ACT-385781A) - Pulmonary Arterial Hypertension'. This trial enrolled 42 participants across Belgium, Canada, France, Italy, Netherlands, and Spain.

How does EFI/ACT-385781A work?

EFI/ACT-385781A is a small molecule, but its specific molecular target has not been disclosed in available information. As such, the exact mechanism of action for this investigational drug in treating pulmonary arterial hypertension is not publicly detailed.