Post Marketing Observational Study in Patients With Pulmonary Arterial Hypertension
- Registration Number
- NCT01066845
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1809
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients prescribed Adcirca tadalafil all patients prescribed Adcirca during study period
- Primary Outcome Measures
Name Time Method The incidence of adverse events related to decreased blood pressure, bleeding, visual disturbance and sudden hearing loss. 2 years
- Secondary Outcome Measures
Name Time Method 6 minute walk distance change from baseline 2 years World Health Organization (WHO) functional class change from baseline 2 years Survival time 2 years Pulmonary arterial pressure change from baseline 2 years Score change of Euro Quality of Life (EQ-5D) from baseline 2 years