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NCT02576002 Clinical Trial

Epidemiology and Treatment Patterns of Paediatric PAH (Pulmonary Arterial Hypertension)

Hypertension, Pulmonary Clinical Trial

Official title:
Study to Estimate the Incidence and Prevalence and Treatment Patterns of Pediatric Pulmonary Hypertension in the US

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02576002
Other study ID # 18515
Secondary ID
Status Completed
Phase N/A
First received October 13, 2015
Last updated February 25, 2016
Start date October 2015
Est. completion date January 2016

Study information
Verified date February 2016
Source Bayer
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

To describe the prevalence, incidence and current treatment and procedures patterns in a US pediatric population with PAH in MarketScan database during the period 2010-2013

Recruitment information / eligibility
Status Completed
Enrollment 2691
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group N/A to 18 Years
Eligibility Inclusion Criteria:

- All PAH patients who were in the MarketScan database and who were under age 18 at some time during the years 2010 through 2013

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Drug:
• Assigned pulmonary hypertension medication
As assigned by treating physician; may include following product classes: - Calcium channel blockers/antagonists - Prostanoids (prostaglandins, thromboxanes, prostacyclines) - Endothelin receptor antagonists - PDE-5 inhibitors - SGc stimulators

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence rate of PAH (pulmonary arterial hypertension) Retrospective analysis of three year period No
Primary Prevalence rate of PAH Retrospective analysis of three year period No
Secondary Assigned drug treatment for PAH measured using the MarketScan database Description of pulmonary hypertension-targeted drugs prescribed in the study population and changes during the study period Retrospective analysis of three year period No
Secondary Diagnostic procedures performed among PAH patients measured using the MarketScan database Retrospective analysis of three year period No
Secondary Prevalence of comorbidities among PAH patients Retrospective analysis of three year period No
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