NCT00666198

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

Special Investigation For Long-term Use Of Revatio (Regulatory Post Marketing Commitment Plan)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,337 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 0 Days
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Pulmonary Hypertension

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-05-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2008-04-24
• Last updated: 2021-02-01
• Results posted: 2017-04-24