Post Marketing Observational Study in Patients With Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension Clinical Trial

Official title:

Safety and Effectiveness of Adcirca (Tadalafil) in Japanese Patients With Pulmonary Arterial Hypertension: Open-label, Non-interventional Observational Study in Japan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01066845
• Other study ID #: 13693
• Secondary ID: H6D-JE-TD01
• Status: Completed
• Phase: N/A
• First received: February 3, 2010
• Last updated: October 23, 2015
• Start date: January 2010
• Est. completion date: August 2014

Study information

• Verified date: October 2015
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1809
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• tadalafil
prescribed in accordance with usual clinical practice

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of adverse events related to decreased blood pressure, bleeding, visual disturbance and sudden hearing loss.		2 years	Yes
Secondary	6 minute walk distance change from baseline		2 years	No
Secondary	World Health Organization (WHO) functional class change from baseline		2 years	No
Secondary	Survival time		2 years	No
Secondary	Pulmonary arterial pressure change from baseline		2 years	No
Secondary	Score change of Euro Quality of Life (EQ-5D) from baseline		2 years	No