Post Marketing Observational Study in Patients With Pulmonary Arterial Hypertension

Lilly

Status: Completed

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: tadalafil

Study type: Observational

Funder types: Industry

Identifiers

NCT01066845

H6D-JE-TD01 (Other Identifier)

13693

Details and patient eligibility

About

To investigate the long-term safety and effectiveness of Adcirca (tadalafil) in Pulmonary Arterial Hypertension (PAH) patients in the clinical practice -focused topics-

1. To evaluate the incidence of adverse events for the patients with long-term use
2. To evaluate the incidence of adverse events of decreased blood pressure, bleeding (including uterine hemorrhage), visual disturbance and sudden hearing loss.

Enrollment: 1,809 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients with PAH receiving Adcirca

Exclusion Criteria:Patients who meet the criteria of contraindication

• patients with hypersensitivity to tadalafil
• patients who are using any form of organic nitrate
• patients with severe renal impairment
• patients with severe hepatic impairment
• patients taking strong inhibitors of CYP3A4
• patients taking strong inducers of CYP3A4

Trial design

1,809 participants in 1 patient group

Patients prescribed Adcirca

Description:

all patients prescribed Adcirca during study period

Treatment:

Drug: tadalafil