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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3337 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pulmonary Hypertension

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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SILDENAFIL

Patients taking SILDENAFIL.

SILDENAFIL

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG