Pulmonary Arterial Hypertension
Conditions
Brief summary
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.
Interventions
DRUGtadalafil
prescribed in accordance with usual clinical practice
Sponsors
Eli Lilly and Company
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse events related to decreased blood pressure, bleeding, visual disturbance and sudden hearing loss. | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Pulmonary arterial pressure change from baseline | 2 years |
| Score change of Euro Quality of Life (EQ-5D) from baseline | 2 years |
| 6 minute walk distance change from baseline | 2 years |
| World Health Organization (WHO) functional class change from baseline | 2 years |
| Survival time | 2 years |
Outcome results
None listed