Post Marketing Observational Study in Patients With Pulmonary Arterial Hypertension

Eli Lilly and Company1,809 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,809

Conditions

Pulmonary Arterial Hypertension

Interventions

tadalafilDRUG

prescribed in accordance with usual clinical practice

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The incidence of adverse events related to decreased blood pressure, bleeding, visual disturbance and sudden hearing loss.

Time frame: 2 years

Secondary Outcomes

6 minute walk distance change from baseline

Time frame: 2 years

World Health Organization (WHO) functional class change from baseline

Time frame: 2 years

Survival time

Time frame: 2 years

Pulmonary arterial pressure change from baseline

Time frame: 2 years

Score change of Euro Quality of Life (EQ-5D) from baseline

Time frame: 2 years

Data from ClinicalTrials.gov

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