Epoprostenol for Injection (EFI) / ACT-385781A - Pulmonary Arterial Hypertension (EPITOME-2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01431716
First received: September 7, 2011
Last updated: March 14, 2013
Last verified: March 2013
  Purpose

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 Epoprostenol for Injection (EFI)/ ACT-385781A and followed-up for 90 days. During these 90 days safety and tolerability of Epoprostenol for Injection (EFI)/ ACT-385781A will closely be monitored in all treated patients. This 90 follow-up will provide clinical evidence on the safety and tolerability of switching from Flolan® to Epoprostenol for Injection (EFI)/ ACT-385781A in patients with pulmonary arterial hypertension.


Condition Intervention Phase
Pulmonary Arterial Hypertension
Drug: Epoprostenol for injection
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients With Pulmonary Arterial Hypertension

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • Change in cardiac hemodynamics [ Time Frame: Baseline to end of study (3 months) ] [ Designated as safety issue: No ]
    Change in cardiac hemodynamics from baseline to end of study (3-months) following switch from Flolan to Epoprostenol


Secondary Outcome Measures:
  • Change in 6-minute walk distance (6MWD) [ Time Frame: Baseline to end of study (3 months) ] [ Designated as safety issue: No ]
    Change from basline to end of study (3 months)in 6-minute walk distance (6MWD)


Enrollment: 42
Study Start Date: March 2011
Study Completion Date: July 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Epoprostenol for injection
Drug: Epoprostenol for injection
Epoprostenol for injection administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
Other Name: ACT-385781A

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 Epoprostenol for injection (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01431716

Locations
Belgium
UZ Gasthuisberg
Leuven, Belgium, 3000
Canada, Ontario
University Health Network, Toronto TGH - 10 EN - 220
Toronto, Ontario, Canada, M5G 2N2
Canada, Quebec
Sir Mortimer B Davis Jewish General Hospital
Montreal, Quebec, Canada, H3T 1 E2
France
Centre Hospitalier Universitaire
Caen, France, 14033
Hôpital Antoine Béclère
Clamart Cedex, France, 92141
Italy
Orsola Malpighi
Bologna, Italy, 40138
Netherlands
VU Medisch Centrum (VUMC)
Amsterdam, Netherlands, 1081 HV
Spain
Hospital Vall d'Hebron
Barcelona, Spain, 8035
Sponsors and Collaborators
Actelion
  More Information

No publications provided

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01431716     History of Changes
Other Study ID Numbers: AC-066A301
Study First Received: September 7, 2011
Last Updated: March 14, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Ethics Review Committee
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes
Italy: Ethics Committee
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Comité Ético de Investigación Clínica

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Epoprostenol
Tezosentan
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on July 23, 2014