Post Marketing Observational Study in Patients With Pulmonary Arterial Hypertension
NCT ID: NCT01066845
Last Updated: 2015-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1809 participants
OBSERVATIONAL
2010-01-31
2014-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients prescribed Adcirca
all patients prescribed Adcirca during study period
tadalafil
prescribed in accordance with usual clinical practice
Interventions
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tadalafil
prescribed in accordance with usual clinical practice
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
15 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Other Identifiers
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13693
Identifier Type: -
Identifier Source: org_study_id
H6D-JE-TD01
Identifier Type: OTHER
Identifier Source: secondary_id
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