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Epoprostenol for Injection (EFI/ACT-385781A) - Pulmonary Arterial Hypertension | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Epoprostenol for Injection (EFI/ACT-385781A) - Pulmonary Arterial Hypertension

A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to EFI/ACT-385781A in Patients With Pulmonary Arterial Hypertension

NCT01431716•Actelion

View on ClinicalTrials.gov

Summary

This study is investigating the effect of switching from Flolan® to Epoprostenol for Injection (EFI/ACT-385781A) in pulmonary arterial hypertension patients currently treated with Flolan®. For this purpose patients being treated for at least 12 months with Flolan® will be switched from Flolan® to EFI/ACT-385781A and followed-up for 90 days. During these 90 days safety and tolerability of EFI/ACT-385781A will closely be monitored in all treated patients. This 90 follow-up will provide clinical evidence on the safety, tolerability, efficacy and treatment satisfaction of switching from Flolan® to EFI/ACT-385781A in patients with pulmonary arterial hypertension.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 Flolan® for at least 12 months and on a stable dose for at least 3 months prior to enrollment
•4. Patients who are currently treated with concomitant PAH therapy listed below must have been treated for at least 90 days and on a stable dose for 30 days prior to enrollment: Bosentan, Ambrisentan, Sitaxsentan, Sildenafil, Tadalafil
•5. Women of childbearing potential must use a reliable method of contraception
•6. Signed informed consent prior to initiation of any study mandated procedure
•7. Known hypersensitivity to the formulations EFI/ACT-385781A or any of its excipients, and Flolan® or any of its excipients
•8. Cerebrovascular events (e.g., transient ischemic attack or stroke) within 6 months of screening
•9. History of myocardial infarction
•10. History of left-sided heart disease, including any of the following:
+11 more criteria

Exclusion Criteria

•1. Patients with respiratory and/or cardiovascular distress in need of emergency care
•2. Known or suspicion of pulmonary veno-occlusive disease (PVOD)
•3. Current use of IV inotropic agents
•4. Current use of any prostacyclin or prostacyclin analog other than Flolan®
•5. Tachycardia with heart rate \> 120 beats/min at rest

Locations (8)

UZ Gasthuisberg

Leuven, Belgium

University Health Network, Toronto TGH - 10 EN - 220

Toronto, Ontario, Canada

Sir Mortimer B Davis Jewish General Hospital

Montreal, Quebec, Canada

Centre Hospitalier Universitaire

Caen, France

Hôpital Antoine Béclère

Clamart, France

Orsola Malpighi

Bologna, Italy

VU Medisch Centrum (VUMC)

Amsterdam, Netherlands

Hospital Vall d'Hebron

Barcelona, Spain

Key Dates

Start Date

March 1, 2011

Primary Completion Date

February 1, 2012

Completion Date

July 1, 2012

Last Updated

January 13, 2015

Enrollment

ACTUAL participants

Conditions

Pulmonary Arterial Hypertension

Interventions

EFI/ACT-385781A

DRUG

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

NCT07218029

Pulmonary Arterial Hypertension

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RECRUITINGPHASE1/PHASE2

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

NCT06649110

Healthy Volunteers, Pulmonary Arterial Hypertension

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RECRUITINGPHASE1

A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 13, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Epoprostenol for Injection (EFI/ACT-385781A) - Pulmonary Arterial Hypertension

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

COMPERA / COMPERA-KIDS

The MObile Health InterVEntion in Pulmonary Arterial Hypertension (MOVE PAH) Study

China Pulmonary Vascular Disease Intervention Diagnosis and Management Study-right Heart Catheterization