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To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension For 112 Weeks

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00946114
First received: July 22, 2009
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
Results First Received: March 29, 2010  
Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: Pulmonary Hypertension
Intervention: Drug: sildenafil

  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
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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
Sildenafil 60 mg Sildenafil 20 mg TID (3 times daily); eligible adult subjects with PAH (pulmonary arterial hypertension)
Sildenafil 240 mg Sildenafil 80 mg TID (3 times daily); subjects who completed study A1481142

Participant Flow:   Overall Study
    Sildenafil 60 mg     Sildenafil 240 mg  
STARTED     20     12  
COMPLETED     12     10  
NOT COMPLETED     8     2  
Death                 5                 2  
Unspecified                 1                 0  
Withdrawal by Subject                 2                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Sildenafil 60 mg Sildenafil 20 mg TID (3 times daily); eligible adult subjects with PAH (pulmonary arterial hypertension)
Sildenafil 240 mg Sildenafil 80 mg TID (3 times daily); subjects who completed study A1481142
Total Total of all reporting groups

Baseline Measures
    Sildenafil 60 mg     Sildenafil 240 mg     Total  
Number of Participants  
[units: participants]
 		  20     12     32  
Age, Customized  
[units: participants]
 		     
18 - 44 years     10     6     16  
45 - 64 years     8     6     14  
>= 65 years     2     0     2  
Gender  
[units: participants]
 		     
Female     17     9     26  
Male     3     3     6  



  Outcome Measures

1.  Primary:   Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline up to 116 Weeks ]
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  Serious Adverse Events
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  Other Adverse Events
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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 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.


Limitations and Caveats
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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Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00946114     History of Changes
Other Study ID Numbers: A1481242
Study First Received: July 22, 2009
Results First Received: March 29, 2010
Last Updated: February 12, 2013
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products