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Epoprostenol for Injection in Patients With Pulmonary Arterial Hypertension (Epitome2ext)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01470144
First received: October 28, 2011
Last updated: March 14, 2013
Last verified: March 2013
History of Changes
  Purpose

This is an open-label, nonrandomized extension to study AC-066A301. The study will assess safety and tolerability of ACT-385781A while providing a means for continuing treatment after ending participation in study AC-066A301.


Condition Intervention Phase
Pulmonary Arterial Hypertension
 Drug: Epoprostenol
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Extension of Study AC-066A301 Investigating the Safety and Tolerability of ACT-385781A in Patients With Pulmonary Arterial Hypertension (PAH)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Actelion:

Primary Outcome Measures:
  • treatment-emergent adverse events [ Time Frame: up to 24 hours post trial ] [ Designated as safety issue: Yes ]
    treatment-emergent adverse events up to 24 hours post end of trial


Secondary Outcome Measures:
  • adverse events [ Time Frame: Baseline to end of study (3 months) ] [ Designated as safety issue: Yes ]
    safety endpoint of adverse events leading to premature discontinuation of study drug


Enrollment: 41
Study Start Date: June 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: epopropstenol Drug: Epoprostenol
Administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump. The dose and infusion rate of EFI may be adjusted throughout the study in order to balance tolerability and maximum clinical benefit.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent prior to initiation of any study-mandated procedure
  2. Patients who completed participation in study AC-066A301
  3. Patients who have not obtained access for commercial EFI at the time of ending participation in study AC-066A301

Exclusion Criteria:

  1. Patients who prematurely discontinued study drug in study AC-066A301
  2. Patients for whom continued treatment with EFI is no longer considered appropriate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01470144

Locations
Belgium
UZ Gasthuisberg - Site 201
Leuven, Belgium, 3000
Canada, Ontario
Univesrity of Toronto
Toronoto, Ontario, Canada, M5G 2N2
Canada, Quebec
Sir Mortimer B Davis Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Actelion
  More Information

No publications provided

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01470144     History of Changes
Other Study ID Numbers: AC-066A302
Study First Received: October 28, 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 May 16, 2013