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

This study has been completed.
Sponsor:
Collaborators:
Effi-stat
Chiltern International Ltd.
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01470144
First received: October 28, 2011
Last updated: October 18, 2016
Last verified: October 2016
Results First Received: October 18, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pulmonary Arterial Hypertension
Intervention: Drug: Epoprostenol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Extension study for patients who completed EPITOME-2 (AC-066A301). Patients continued to receive EFI (epoprostenol sodium). In 6 countries (FR, CA, BE, NL, IT, ES) at 8 expert centers for the treatment of patients with pulmonary arterial hypertension. Recruitment started on 15 June 2011 and was completed on 02 February 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Treatment All patients who received at least one dose of EFI

Participant Flow:   Overall Study
    Treatment
STARTED   41 
COMPLETED   31 [1] 
NOT COMPLETED   10 
Adverse Event                2 
Death                1 
Lung transplant                6 
Patient’s and investigator’s decision                1 
[1] "Completed" corresponds to subjects switching to commercial EFI upon market approval/reimbursement



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment All patients who received at least one dose of EFI

Baseline Measures
   Treatment 
Overall Participants Analyzed 
[Units: Participants]
 41 
Age 
[Units: Years]
Median (Full Range)
 46.0 
 (23 to 78) 
Gender 
[Units: Participants]
 
Female   30 
Male   11 


  Outcome Measures
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1.  Primary:   Treatment-emergent Adverse Events   [ Time Frame: Up to 24 hours post treatment ]

2.  Secondary:   Exposure Duration   [ Time Frame: Study start to end of treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Thomas Pfister, PhD
Organization: Actelion Pharmaceuticals Ltd
e-mail: thomas.pfister@actelion.com



Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01470144     History of Changes
Other Study ID Numbers: AC-066A302
Study First Received: October 28, 2011
Results First Received: October 18, 2016
Last Updated: October 18, 2016
Health Authority: Spain: Comité Ético de Investigación Clínica
Canada: Ethics Review Committee
Italy: Ethics Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Belgium: Federal Agency for Medicinal Products and Health Products
Spain: Agencia Española de Medicamentos y Productos Sanitarios
France: Committee for the Protection of Personnes
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Canada: Health Canada