OPsumit USers Registry

Trial ID or NCT#

NCT02126943

Status

recruiting iconRECRUITING

Purpose

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.

Official Title

US-based, Observational, Drug Registry of Opsumit® (Macitentan) New Users in Clinical Practice

Eligibility Criteria

Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. Patients newly treated with Opsumit defined as a new user of therapy, initiated ≤ 30 days prior to enrollment visit. Signed ICF
Exclusion Criteria:
  1. Previous user of Opsumit defined as patient who initiated therapy >30 days prior to enrollment. Patients enrolled in any ongoing clinical trials
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Investigator(s)

Roham Zamanian
Roham Zamanian
Pulmonary hypertension specialist, Pulmonologist, Critical care specialist
Professor of Medicine (Pulmonary and Critical Care Medicine)
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View on ClinicalTrials.gov