Brief Summary
Prospective observational drug registry developed to characterize the safety profile (including primarily potential serious hepatic risks) and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting.
Brief Title
OPsumit USers Registry
Categories
Completion Date
Completion Date Type
Actual
Conditions
Pulmonary Arterial Hypertension
Eligibility Criteria
Inclusion Criteria:
Patients newly treated with Opsumit defined as a new user of therapy, initiated ≤ 30 days prior to enrollment visit.
Signed ICF
Exclusion Criteria:
Previous user of Opsumit defined as patient who initiated therapy \>30 days prior to enrollment.
Patients enrolled in any ongoing clinical trials
Patients newly treated with Opsumit defined as a new user of therapy, initiated ≤ 30 days prior to enrollment visit.
Signed ICF
Exclusion Criteria:
Previous user of Opsumit defined as patient who initiated therapy \>30 days prior to enrollment.
Patients enrolled in any ongoing clinical trials
Inclusion Criteria
Inclusion Criteria:
Patients newly treated with Opsumit defined as a new user of therapy, initiated ≤ 30 days prior to enrollment visit.
Signed ICF
Patients newly treated with Opsumit defined as a new user of therapy, initiated ≤ 30 days prior to enrollment visit.
Signed ICF
Gender
All
Gender Based
false
Keywords
PAH
pulmonary arterial hypertension
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
NCT Id
NCT02126943
Org Class
Industry
Org Full Name
Actelion
Org Study Id
AC-055-503
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
US-based, Observational, Drug Registry of Opsumit® (Macitentan) New Users in Clinical Practice
Primary Outcomes
Outcome Description
Liver test abnormalities/ Occurrence of Hepatic Adverse Events (HAEs)/ Occurrence of any other AEs/ Discontinuation of Opsumit and reason for stopping therapy/ Hospitalization and death.
Outcome Measure
To estimate incidence rates for specified outcomes.
Outcome Time Frame
1 year
Secondary Outcomes
Outcome Time Frame
1 year
Outcome Measure
To describe demographic and clinical characteristics of patients treated with Opsumit at enrollment and during observation period.
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
Patients newly treated with Opsumit
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Sandhya Murthy
Investigator Email
smurthy@montefiore.org
Investigator Phone
718-904-3507