Post Marketing Observational Study in Patients With Pulmonary Arterial Hypertension
Safety and Effectiveness of Adcirca (Tadalafil) in Japanese Patients With Pulmonary Arterial Hypertension: Open-label, Non-interventional Observational Study in Japan
2 other identifiers
observational
1,809
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2010
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 3, 2010
CompletedFirst Posted
Study publicly available on registry
February 10, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedOctober 26, 2015
October 1, 2015
4.6 years
February 3, 2010
October 23, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
The incidence of adverse events related to decreased blood pressure, bleeding, visual disturbance and sudden hearing loss.
2 years
Secondary Outcomes (5)
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
Study Arms (1)
Patients prescribed Adcirca
all patients prescribed Adcirca during study period
Interventions
prescribed in accordance with usual clinical practice
Eligibility Criteria
Japanese patients prescribed Adcirca from clinical practices
You may qualify if:
- Patients with PAH receiving Adcirca
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2010
First Posted
February 10, 2010
Study Start
January 1, 2010
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
October 26, 2015
Record last verified: 2015-10