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

Primary Purpose

Pulmonary Arterial Hypertension

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Epoprostenol
Sponsored by
Actelion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UZ Gasthuisberg
  • University of Toronto
  • Sir Mortimer B Davis Jewish General Hospital
  • CHU Caen
  • Hôpital Kremlin Bicêtre
  • Ospedale Sant'Orsola
  • VUMC
  • Hospital 12 de Octubre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Single arm, open-label

Outcomes

Primary Outcome Measures

Treatment-emergent Adverse Events

Secondary Outcome Measures

Exposure Duration
Duration of exposure to EFI

Full Information

First Posted
October 28, 2011
Last Updated
June 1, 2017
Sponsor
Actelion
Collaborators
Chiltern International Ltd., Effi-Stat
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1. Study Identification

Unique Protocol Identification Number
NCT01470144
Brief Title
Epoprostenol for Injection in Patients With Pulmonary Arterial Hypertension
Acronym
Epitome2ext
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
June 1, 2011 (Actual)
Primary Completion Date
June 1, 2015 (Actual)
Study Completion Date
July 1, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actelion
Collaborators
Chiltern International Ltd., Effi-Stat

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Single arm, open-label
Intervention Type
Drug
Intervention Name(s)
Epoprostenol
Intervention Description
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
Primary Outcome Measure Information:
Title
Treatment-emergent Adverse Events
Time Frame
On average 2.72 years
Secondary Outcome Measure Information:
Title
Exposure Duration
Description
Duration of exposure to EFI
Time Frame
On average 2.72 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent prior to initiation of any study-mandated procedure Patients who completed participation in study AC-066A301 Patients who have not obtained access for commercial EFI at the time of ending participation in study AC-066A301 Exclusion Criteria: Patients who prematurely discontinued study drug in study AC-066A301 Patients for whom continued treatment with EFI is no longer considered appropriate
Facility Information:
Facility Name
UZ Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
University of Toronto
City
Toronoto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
Sir Mortimer B Davis Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
CHU Caen
City
Caen
Country
France
Facility Name
Hôpital Kremlin Bicêtre
City
Paris
Country
France
Facility Name
Ospedale Sant'Orsola
City
Bologna
ZIP/Postal Code
40438
Country
Italy
Facility Name
VUMC
City
Amsterdam
Country
Netherlands
Facility Name
Hospital 12 de Octubre
City
Madrid
Country
Spain

12. IPD Sharing Statement

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Epoprostenol for Injection in Patients With Pulmonary Arterial Hypertension

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