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

Viatris

Status: Completed

Conditions: Pulmonary Hypertension

Treatments: Drug: SILDENAFIL

Study type: Observational

Funder types: Industry

Identifiers

NCT00666198

A1481263

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,337 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Patients not administered SILDENAFIL(Revatio).

Trial design

3,337 participants in 1 patient group

SILDENAFIL

Description:

Patients taking SILDENAFIL.

Treatment:

Drug: SILDENAFIL