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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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2 November 2015 |
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Main ID: |
NCT01066845 |
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Date of registration:
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03/02/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Post Marketing Observational Study in Patients With Pulmonary Arterial Hypertension
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Scientific title:
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Safety and Effectiveness of Adcirca (Tadalafil) in Japanese Patients With Pulmonary Arterial Hypertension: Open-label, Non-interventional Observational Study in Japan |
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Date of first enrolment:
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January 2010 |
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Target sample size:
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1809 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01066845 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Contacts
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Name:
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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) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eli Lilly and Company |
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Key inclusion & exclusion criteria
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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
Age minimum:
15 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pulmonary Arterial Hypertension
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Intervention(s)
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Drug: tadalafil
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Primary Outcome(s)
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The incidence of adverse events related to decreased blood pressure, bleeding, visual disturbance and sudden hearing loss.
[Time Frame: 2 years]
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Secondary Outcome(s)
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Survival time
[Time Frame: 2 years]
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Pulmonary arterial pressure change from baseline
[Time Frame: 2 years]
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Score change of Euro Quality of Life (EQ-5D) from baseline
[Time Frame: 2 years]
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6 minute walk distance change from baseline
[Time Frame: 2 years]
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World Health Organization (WHO) functional class change from baseline
[Time Frame: 2 years]
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Secondary ID(s)
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H6D-JE-TD01
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13693
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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