Special Investigation For Long-Term Use Of Sildenafil (Regulatory Post Marketing Commitment Plan)
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ClinicalTrials.gov Identifier: NCT00666198 |
Recruitment Status
:
Completed
First Posted
: April 24, 2008
Results First Posted
: April 24, 2017
Last Update Posted
: April 24, 2017
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Condition or disease | Intervention/treatment |
---|---|
Pulmonary Hypertension | Drug: SILDENAFIL |
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 |
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. |
- 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.
- 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.
- 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.
- 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.
- 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".
- 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.
- 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.
- 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.
- 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".
- 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.

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Patients need to be administered SILDENAFIL(Revatio) in order to be enrolled in the surveillance.
Exclusion Criteria:
- Patients not administered SILDENAFIL(Revatio).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00666198
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00666198 History of Changes |
Other Study ID Numbers: |
A1481263 |
First Posted: | April 24, 2008 Key Record Dates |
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 |