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

Information source: Actelion
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Arterial Hypertension

Intervention: EFI/ACT-385781A (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Actelion

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.

Clinical Details

Official title: 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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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

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

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

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

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

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 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 6. PAH related to any condition other than those specified in the inclusion criteria 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:

- hemodynamically significant aortic or mitral valve disease

- restrictive or congestive cardiomyopathy

- left ventricular ejection fraction < 40% by multigated radionucleotide angiogram

(MUGA), angiography, or echocardiography

- unstable angina pectoris

- life-threatening cardiac arrhythmias

11. Chronic bleeding disorders 12. Central venous line infection within 90 days prior to screening and/or a history of recurring line infections 13. Women who are pregnant or breast-feeding 14. Participation in another clinical trial, except observational, or receipt of an investigational product within 30 days prior to randomization 15. Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease 16. Known concomitant life-threatening disease other than PAH with a life expectancy < 12 months

Locations and Contacts

UZ Gasthuisberg, Leuven 3000, Belgium

Centre Hospitalier Universitaire, Caen 14033, France

Hôpital Antoine Béclère, Clamart Cedex 92141, France

Orsola Malpighi, Bologna 40138, Italy

VU Medisch Centrum (VUMC), Amsterdam 1081 HV, Netherlands

Hospital Vall d'Hebron, Barcelona 8035, Spain

University Health Network, Toronto TGH - 10 EN - 220, Toronto, Ontario M5G 2N2, Canada

Sir Mortimer B Davis Jewish General Hospital, Montreal, Quebec H3T 1 E2, Canada

Additional Information

Starting date: March 2011
Last updated: January 2, 2015

Page last updated: August 23, 2015

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