We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Special Investigation For Long-Term Use Of Sildenafil (Regulatory Post Marketing Commitment Plan)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00666198
First Posted: April 24, 2008
Last Update Posted: April 24, 2017
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):
Pfizer
Results First Submitted: February 28, 2017  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Pulmonary Hypertension
Intervention: Drug: SILDENAFIL

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Revatio (Sildenafil Citrate) Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.

Participant Flow:   Overall Study
    Revatio (Sildenafil Citrate)
STARTED   3337 
COMPLETED   3304 
NOT COMPLETED   33 
Protocol Violation                10 
No Visit After First Day of Treatment                13 
Safety Not Assessable                6 
No Drug Administration                4 



  Baseline Characteristics
  Hide Baseline Characteristics

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.
A total of 3304 participants received sildenafil citrate at least once in this study. Of the 3304 participants, 33 participants were excluded from the baseline analysis due to following reasons: protocol violation, no visit after first day of treatment, safety not assessable and no drug administration.

Reporting Groups
  Description
Revatio (Sildenafil Citrate) Participants who received Revaio (Sildenafil citrate) as indicated in the approved local product document were observed for a period of 3 years. The dosage can be adjusted as per physician’s discretion.

Baseline Measures
   Revatio (Sildenafil Citrate) 
Overall Participants Analyzed 
[Units: Participants]
 3304 
Age, Customized 
[Units: Participants]
 
˂65 years   2406 
≥65 years   898 
Age, Customized 
[Units: Participants]
 
˂15 years   1050 
≥15 years   2254 
Sex/Gender, Customized 
[Units: Participants]
 
Female   2057 
Male   1247 
Disease Type [1] 
[Units: Participants]
 
Idiopathic/Familial PAH (IPAH/FPAH)   745 
Collagen Vascular Disease*   666 
Congenital Systemic to Pulmonary Shunts*   985 
PVOD/PCH**   44 
Persistent PH of the Newborn (PPHN)   59 
Other PAH (Portal Hypertention/HIV Infection etc.)   139 
Other Than PAH   665 
Unknown   1 
[1] Categorization of PAH in the study. * indicates "Associated Pulmonary Arterial Hypertension (APAH)". ** refers to "Pulmonary Veno Occlusive Disease/Pulmonary Capillary Hemangiomatosis".
WHO Functional Classification of PAH [1] 
[Units: Participants]
 
Class I   344 
Class II   1012 
Class III   1279 
Class IV   545 
Not Classified   124 
[1] This system grades PAH severity according to the functional status of the patient. The grades range from Functional Class (FC) I, where the patient's disease does not affect their day-to-day activities, to FC IV, where patients are severely functionally impaired, even at rest. This functional classification system links symptoms with activity limitations, and allows clinicians to quickly predict disease progression and prognosis, as well as the need for specific treatment regimens, irrespective of the underlying etiology of PAH.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Treatment-Related Adverse Events   [ Time Frame: 3 years ]

2.  Primary:   Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert   [ Time Frame: 3 years ]

3.  Primary:   Number of Paritcipants With Treatment-Related Adverse Events by Age   [ Time Frame: 3 years ]

4.  Primary:   Number of Paritcipants With Treatment-Related Adverse Events by Gender   [ Time Frame: 3 years ]

5.  Primary:   Number of Participants With Treatment-Related Adverse Events by Disease Type   [ Time Frame: 3 years ]

6.  Primary:   Number of Participants With Treatmnt-Related Adverse Events by WHO Functional Classification of Severity   [ Time Frame: 3 years ]

7.  Primary:   Clinical Efficacy Rate by Age   [ Time Frame: 3 years ]

8.  Primary:   Clinical Efficacy Rate by Gender   [ Time Frame: 3 years ]

9.  Primary:   Clinical Efficacy Rate by Disease Type   [ Time Frame: 3 years ]

10.  Primary:   Clinical Efficacy Rate by WHO Functional Classificaton of Severity   [ Time Frame: 3 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide More Information

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: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00666198     History of Changes
Other Study ID Numbers: A1481263
First Submitted: April 22, 2008
First Posted: April 24, 2008
Results First Submitted: February 28, 2017
Results First Posted: April 24, 2017
Last Update Posted: April 24, 2017