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

Study Description

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Brief Summary:

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Condition or disease	Intervention/treatment
Pulmonary Hypertension	Drug: SILDENAFIL

Detailed Description:

All the patients whom an investigator prescribes the first SILDENAFIL(Revatio) should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Study Design

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Study Type :	Observational
Actual Enrollment :	3337 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
Official Title:	Special Investigation For Long-term Use Of Revatio (Regulatory Post Marketing Commitment Plan)
Study Start Date :	May 2008
Actual Primary Completion Date :	June 2015
Actual Study Completion Date :	June 2015

Groups and Cohorts

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Group/Cohort	Intervention/treatment
SILDENAFIL; Patients taking SILDENAFIL.	Drug: SILDENAFIL; Revatio® Tablets 20 mg Dosage, Frequency: According to Japanese LPD, "For oral use, the adult dose is 20 mg three times a day". Duration: According to the protocol of A1481263, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 3 years after the first administration.

Outcome Measures

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Primary Outcome Measures :

1. Number of Participants With Treatment-Related Adverse Events [ Time Frame: 3 years ]
   A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to sildenafil citrate was assessed by the physician/investigator.
2. Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert [ Time Frame: 3 years ]
   A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to sildenafil citrate was assessed by the physician/investigator.
3. Number of Paritcipants With Treatment-Related Adverse Events by Age [ Time Frame: 3 years ]
   A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Relatedness to sildenafil citrate was assessed by the physician/investigator. Participants with treatment related adverse events were counted by age to assess whether it was risk factor for the treatment related adverse events.
4. Number of Paritcipants With Treatment-Related Adverse Events by Gender [ Time Frame: 3 years ]
   A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Relatedness to sildenafil citrate was assessed by the physician/investigator. Participants with treatment related adverse events were counted by gender to assess whether it was risk factor for the treatment related adverse events.
5. Number of Participants With Treatment-Related Adverse Events by Disease Type [ Time Frame: 3 years ]

   A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Relatedness to sildenafil citrate was assessed by the physician/investigator. Participants with treatment related adverse events were counted by disease type to assess whether it was risk factor for the treatment related adverse events.

   * indicates "Associated Pulmonary Arterial Hypertension (APAH)". ** refers to "Pulmonary Veno Occlusive Disease/Pulmonary Capillary Hemangiomatosis".

6. Number of Participants With Treatmnt-Related Adverse Events by WHO Functional Classification of Severity [ Time Frame: 3 years ]
   A treatment-related adverse event was any untoward medical occurrence attributed to sildenafil citrate in a participant who received sildenafil citrate. Relatedness to sildenafil citrate was assessed by the physician/investigator. Participants with treatment related adverse events were counted by severity (WHO functional classification for PAH range;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) to assess whether it was risk factor for the treatment related adverse events.
7. Clinical Efficacy Rate by Age [ Time Frame: 3 years ]
   Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of sildenafil citrate was assessed as "effective," "ineffective" or "unassessable" by the physician/investigator. Overall effectiveness of sildenafil citrate was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as echocardiogram. Participants achieved clinical effectiveness by age were counted to assess whether it contributes to the clinical effectiveness.
8. Clinical Efficacy Rate by Gender [ Time Frame: 3 years ]
   Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of sildenafil citrate was assessed as "effective," "ineffective" or "unassessable" by the physician/investigator. Overall effectiveness of sildenafil citrate was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as echocardiogram. Participants achieved clinical effectiveness by gender were counted to assess whether it contributes to the clinical effectiveness.
9. Clinical Efficacy Rate by Disease Type [ Time Frame: 3 years ]

   Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of sildenafil citrate was assessed as "effective," "ineffective" or "unassessable" by the physician/investigator. Overall effectiveness of sildenafil citrate was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as echocardiogram. Participants achieved clinical effectiveness by disease type were counted to assess whether it contributes to the clinical effectiveness.

   * indicates "Associated Pulmonary Arterial Hypertension (APAH)". ** refers to "Pulmonary Veno Occlusive Disease/Pulmonary Capillary Hemangiomatosis".

10. Clinical Efficacy Rate by WHO Functional Classificaton of Severity [ Time Frame: 3 years ]
    Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented. Clinical effectiveness of sildenafil citrate was assessed as "effective," "ineffective" or "unassessable" by the physician/investigator. Overall effectiveness of sildenafil citrate was determined by the physician/investigator based on clinical symptoms, laboratory values, and other examinations such as echocardiogram. Participants achieved clinical effectiveness by severity (WHO functional classification of PAH;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) were counted to assess whether it contributes to the clinical effectiveness.

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

The patients whom an investigator involving A1481263 prescribes the SILDENAFIL(Revatio).

Criteria

Inclusion Criteria:

• Patients need to be administered SILDENAFIL(Revatio) in order to be enrolled in the surveillance.

Exclusion Criteria:

• Patients not administered SILDENAFIL(Revatio).

Contacts and Locations

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Sponsors and Collaborators

Pfizer

Investigators

Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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Additional Information:

To obtain contact information for a study center near you, click here. 

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

Additional relevant MeSH terms:

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Sildenafil Citrate; Vasodilator Agents	Phosphodiesterase 5 Inhibitors; Phosphodiesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Urological Agents