NCT02126943CompletedNot Applicable
US-based, Observational, Drug Registry of Opsumit® (Macitentan) New Users in Clinical Practice
Actelion1 site in 1 country2,686 target enrollmentStarted: April 30, 2014Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 2,686
- Locations
- 1
- Primary Endpoint
- To estimate incidence rates for specified outcomes.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients newly treated with Opsumit defined as a new user of therapy, initiated ≤ 30 days prior to enrollment visit.
Exclusion Criteria
- •Previous user of Opsumit defined as patient who initiated therapy >30 days prior to enrollment.
- •Patients enrolled in any ongoing clinical trials
Arms & Interventions
Opsumit (macitentan)
10 mg tablets
Intervention: Opsumit (macitentan) (Drug)
Outcomes
Primary Outcomes
To estimate incidence rates for specified outcomes.
Time Frame: 1 year
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.
Secondary Outcomes
- To describe demographic and clinical characteristics of patients treated with Opsumit at enrollment and during observation period.(1 year)
Investigators
Study Sites (1)
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