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Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension (PROWESS 15 Ext)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00709098
First Posted: July 3, 2008
Last Update Posted: September 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Actelion
Results First Submitted: September 27, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pulmonary Arterial Hypertension
Intervention: Drug: iloprost

  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
The double-blind period of the study was conducted at 20 centers in the US and Germany, and the following open-label period of the study was conducted at 17 centers in the US only. First patient, first visit was 4 September 2008 and the last patient, last visit was 17 June 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of the 63 patients who completed the core study of AC-063A301, 49 gave informed consent and enrolled into this extension study.

Reporting Groups
  Description
Iloprost Power 6 (Double-blind Period) The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
Iloprost Power 15 (Double-blind Period) The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
Iloprost Power 15 (Open-label Period) The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc

Participant Flow for 2 periods

Period 1:   Double-blind Period
    Iloprost Power 6 (Double-blind Period)   Iloprost Power 15 (Double-blind Period)   Iloprost Power 15 (Open-label Period)
STARTED   25   24   0 
COMPLETED   19   16   0 
NOT COMPLETED   6   8   0 
Withdrawal of consent                3                3                0 
Administrative reason                1                3                0 
Death                1                1                0 
Lost to Follow-up                1                1                0 

Period 2:   Open-label Period
    Iloprost Power 6 (Double-blind Period)   Iloprost Power 15 (Double-blind Period)   Iloprost Power 15 (Open-label Period)
STARTED   0   0   32 [1] 
COMPLETED   0   0   18 
NOT COMPLETED   0   0   14 
Withdrawal of consent                0                0                7 
Administrative reason                0                0                5 
Death                0                0                1 
Lost to Follow-up                0                0                1 
[1] The open-label period was only made available to patients in US centers



  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 Power 6 (Double-blind Period) The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
Iloprost Power 15 (Double-blind Period) The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
Iloprost Power 15 (Open-label Period) The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
Total Total of all reporting groups

Baseline Measures
   Iloprost Power 6 (Double-blind Period)   Iloprost Power 15 (Double-blind Period)   Iloprost Power 15 (Open-label Period)   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   24   0   49 
Age 
[Units: Years]
Mean (Full Range)
 58.3 
 (25 to 87) 
 55.4 
 (29 to 79) 
    56.9 
 (25 to 87) 
Gender 
[Units: Participants]
       
Female   19   19      38 
Male   6   5      11 
Region of Enrollment 
[Units: Participants]
       
United States   23   22      45 
Germany   2   2      4 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Treatment-emergent Adverse Events   [ Time Frame: Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication, mean duration of exposure was 284.5 days. ]

2.  Primary:   Treatment-emergent Serious Adverse Events   [ Time Frame: Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication, mean duration of exposure was 284.5 days. ]

3.  Primary:   Adverse Events Leading to Premature Discontinuation of Study Drug   [ Time Frame: Double-blind period: from the first inhalation of study drug to discontinuation. Open-label period: from the start of open-label medication to discontinuation, mean duration of exposure was 284.5 days. ]

4.  Primary:   Patients With Adverse Events Leading to Premature Discontinuation of Study Drug   [ Time Frame: Double-blind period: from the first inhalation of study drug to discontinuation. Open-label period: from the start of open-label medication to discontinuation, mean duration of exposure was 284.5 days. ]

5.  Other Pre-specified:   Average Inhalation Time   [ Time Frame: 12 weeks ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Laila Rouault, MD/International Clinical Leader
Organization: Actelion Pharmaceuticals Ltd
phone: + 41 61 565 8128



Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT00709098     History of Changes
Other Study ID Numbers: AC-063A302
First Submitted: July 1, 2008
First Posted: July 3, 2008
Results First Submitted: September 27, 2012
Results First Posted: October 29, 2012
Last Update Posted: September 28, 2015