Effects of Ventavis in Patients With Pulmonary Hypertension (PH) Secondary to Chronic Obstructive Pulmonary Disease (COPD)

This study has been terminated.
(low recruitment)
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01437878
First received: September 20, 2011
Last updated: January 2, 2015
Last verified: January 2015
Results First Received: December 12, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Pulmonary Hypertension
Chronic Obstructive Pulmonary Disease
Interventions: Drug: Iloprost
Drug: Placebo

  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 screened at 4 centres in the US, one centre in France, and one site in Spain. First patient, first visit was 1 March 2012 and last patient, last visit was 30 November 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 22 patients were screened for the study, of these 20 were not randomized because they did not meet the selection criteria.

Reporting Groups
  Description
Iloprost

single dose inhalation using the power disc-6 with I-neb Adaptive Aerosol Delivery (AAD) system

Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks

Placebo

matching placebo using the power disc-6 with I-neb AAD system

Placebo: matching placebo


Participant Flow:   Overall Study
    Iloprost     Placebo  
STARTED     1 [1]   1  
COMPLETED     0     1  
NOT COMPLETED     1     0  
Withdrawal by Subject                 1                 0  
[1] Patient discontinued the study prior to initiation of study treatment



  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
Iloprost

single dose inhalation using the power disc-6 with I-neb AAD system

Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks

Placebo

matching placebo using the power disc-6 with I-neb AAD system

Placebo: matching placebo

Total Total of all reporting groups

Baseline Measures
    Iloprost     Placebo     Total  
Number of Participants  
[units: participants]
  1     1     2  
Age, Customized  
[units: participants]
     
Age 64 years     1     0     1  
Age 74 years     0     1     1  
Gender  
[units: participants]
     
Female     0     1     1  
Male     1     0     1  
Region of Enrollment  
[units: participants]
     
France     1     0     1  
United States     0     1     1  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Endurance Time   [ Time Frame: Baseline to week 4 ]

2.  Secondary:   Participants With Treatment-emergent Adverse Events   [ Time Frame: Baseline up to 24 hours post-EOT, approximately 4 weeks ]

3.  Secondary:   Change in Systolic Pulmonary Arterial Pressure   [ Time Frame: 15 minutes ]

4.  Secondary:   Change in Diastolic Pulmonary Arterial Pressure   [ Time Frame: 15 minutes ]

5.  Secondary:   Change in Mean Pulmonary Arterial Pressure   [ Time Frame: 15 minutes ]

6.  Secondary:   Change in Mean Right Atrial Pressure   [ Time Frame: 15 minutes ]

7.  Secondary:   Change in Cardiac Output   [ Time Frame: 15 minutes ]

8.  Secondary:   Change in Right Ventricular Pressure   [ Time Frame: 15 minutes ]

9.  Secondary:   Change in Pulmonary Vascular Resistance   [ Time Frame: 15 minutes ]

10.  Secondary:   Change in End Tidal Partial Pressure of Carbon Dioxide   [ Time Frame: Baseline to week 4 ]

11.  Secondary:   Change in End Tidal Partial Pressure of Oxygen   [ Time Frame: Baseline to week 4 ]

12.  Secondary:   Change in Oxygen Uptake   [ Time Frame: Baseline to week 4 ]

13.  Secondary:   Change in Carbon Dioxide Output   [ Time Frame: Baseline to week 4 ]

14.  Secondary:   Change in Oxygen Uptake Per Heartbeat   [ Time Frame: Baseline to week 4 ]

15.  Secondary:   Change in Heart Rate   [ Time Frame: Baseline to week 4 ]

16.  Secondary:   Change in Arterial Oxygen Saturation as Indicated by Pulse Oximetry   [ Time Frame: Baseline to week 4 ]

17.  Secondary:   Change in Tidal Volume   [ Time Frame: Baseline to week 4 ]

18.  Secondary:   Change in Minute Ventilation   [ Time Frame: Baseline to week 4 ]


  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
No text entered.


  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 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.


Results Point of Contact:  
Name/Title: Maziar Assadi Gehr
Organization: Actelion Pharmaceutical Ltd
phone: +41 61 565 5525
e-mail: maziar.assadi-gehr@actelion.com


No publications provided


Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01437878     History of Changes
Other Study ID Numbers: AC-063B201
Study First Received: September 20, 2011
Results First Received: December 12, 2014
Last Updated: January 2, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes
France: Conseil National de l'Ordre des Médecins
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Comité Ético de Investigación Clínica