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: January 2, 2015
Last verified: January 2015
Results First Received: January 2, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pulmonary Arterial Hypertension
Intervention: Drug: EFI/ACT-385781A

  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
Patients were enrolled at eight centers in the European Union and Canada. First patient, first visit was 15 March 2011 and last patient, last visit was 2 February 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients must have been treated with Flolan for at least 12 months and on a stable dose for at least 3 months prior to enrollment. There was a screening period of up to 14 days.

Reporting Groups
  Description
Epoprostenol for Injection (EFI/ACT-385781A) EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.

Participant Flow:   Overall Study
    Epoprostenol for Injection (EFI/ACT-385781A)  
STARTED     42  
COMPLETED     41  
NOT COMPLETED     1  
Withdrawal of consent                 1  



  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.
All-treated set (One patient enrolled in the study but withdrew consent prior completing baseline assessment and receiving study drug).

Reporting Groups
  Description
EFI/ACT-385781A EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.

Baseline Measures
    EFI/ACT-385781A  
Number of Participants  
[units: participants]
  41  
Age  
[units: years]
Mean ± Standard Deviation
  44.8  ± 13.9  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     38  
>=65 years     3  
Gender  
[units: participants]
 
Female     30  
Male     11  
Race/Ethnicity, Customized  
[units: participants]
 
White/Caucasian     18  
Black     2  
Asian     1  
Not Collected     20  
Region of Enrollment  
[units: participants]
 
France     20  
Canada     8  
Spain     2  
Belgium     5  
Netherlands     4  
Italy     2  



  Outcome Measures
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1.  Primary:   Change in Pulmonary Vascular Resistance From Baseline to End of Treatment (EOT).   [ Time Frame: Approximately 3 months ]

2.  Primary:   Change in Total Pulmonary Resistance From Baseline to End of Treatment (EOT).   [ Time Frame: Approximately 3 months ]

3.  Primary:   Change in Mean Pulmonary Arterial Pressure From Baseline to End of Treatment (EOT).   [ Time Frame: Approximately 3 months ]

4.  Primary:   Change in Mean Right Atrial Pressure From Baseline to End of Treatment (EOT).   [ Time Frame: Approximately 3 months ]

5.  Primary:   Change in Pulmonary Capillary Wedge Pressure From Baseline to End of Treatment (EOT).   [ Time Frame: Approximately 3 months ]

6.  Primary:   Change in Mean Cardiac Index From Baseline to End of Treatment (EOT).   [ Time Frame: Approximately 3 months ]

7.  Other Pre-specified:   Change in 6-minute Walk Distance (6MWD) From Baseline to EOT.   [ Time Frame: Approximately 3 months ]

8.  Other Pre-specified:   Change in Borg Dyspnea Score From Baseline to EOT.   [ Time Frame: Approximately 3 months ]

9.  Other Pre-specified:   Number of Participants With Improved, No Change, or Worsening of New York Heart Association Functional Class (NYHA FC) From Baseline to EOT.   [ Time Frame: Approximately 3 months ]

10.  Other Pre-specified:   Change in N-terminal Pro-B-type Natriuretic Peptide (NT proBNP) From Baseline to EOT.   [ Time Frame: Approximately 3 months ]

11.  Other Pre-specified:   Change in Effectiveness Score of the Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) From Baseline to EOT.   [ Time Frame: Approximately 3 months ]

12.  Other Pre-specified:   Change in Convenience Score of the Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) From Baseline to EOT.   [ Time Frame: Approximately 3 months ]

13.  Other Pre-specified:   Change in Global Satisfaction Score of the Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) From Baseline to EOT.   [ Time Frame: Approximately 3 months ]

14.  Other Pre-specified:   Number of Participants With Adverse Events Leading to Discontinuation of Study Drug From Baseline to EOT.   [ Time Frame: Approximately 3 months ]


  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 more than 60 days but less than or equal to 180 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, Senior Clinical Scientist
Organization: Actelion Pharmaceuticals Ltd
phone: +41 61 565 5932
e-mail: thomas.pfister@actelion.com


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
Results First Received: January 2, 2015
Last Updated: January 2, 2015
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