NL-OMON52230
Completed
Not Applicable
An international, non-drug interventional, real-world cohort of PAH patients newly initiating PAH therapy with guideline-directed assessments of disease severity - CARE PAH
Actelion Pharmaceuticals0 sites12 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Increased bloodpressure in the arteries of the lung
- Sponsor
- Actelion Pharmaceuticals
- Enrollment
- 12
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial ended prematurely
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Signed ICF.
- •2\. Male or female participants age \>\=18 years.
- •3\. Symptomatic PAH in any PAH subtype.
- •4\. PAH diagnosis confirmed by hemodynamic evaluation at rest at any time prior
- •to or at the index date fulfilling all of the criteria below:
- •a) Mean pulmonary artery pressure \>20 mmHg, AND
- •b) Pulmonary artery wedge pressure or left ventricular end diastolic pressure
- •\<\=15 mmHg, AND
- •c) Pulmonary vascular resistance \>\= 3 Wood Units (ie, \>\=240 dyn\*sec/cm5\).
- •5\. Newly initiating 1 or more PAH therapy(ies) (as monotherapy or add\-on
Exclusion Criteria
- •1\. Participants enrolled in any interventional clinical trial with an
- •investigational therapy in the 3\-month period prior to index date.
- •2\. Any PAH therapy initiated at index date was used by the participant
- •(including different route of administration of the same compound) within 3
- •months prior to index date for any reason. (Administration for vasoreactivity
- •testing is permitted.)
- •3\. presence or known presence of moderate or severe obstructive lung disease
- •4\. presence or known presence of moderate or severe restrictive lung disease
Outcomes
Primary Outcomes
Not specified
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