Epidemiology and Treatment Patterns of Paediatric PAH (Pulmonary Arterial Hypertension)
Study to Estimate the Incidence and Prevalence and Treatment Patterns of Pediatric Pulmonary Hypertension in the US
1 other identifier
observational
2,691
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2015
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 13, 2015
CompletedFirst Posted
Study publicly available on registry
October 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedFebruary 26, 2016
February 1, 2016
3 months
October 13, 2015
February 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence rate of PAH (pulmonary arterial hypertension)
Retrospective analysis of three year period
Prevalence rate of PAH
Retrospective analysis of three year period
Secondary Outcomes (3)
Assigned drug treatment for PAH measured using the MarketScan database
Retrospective analysis of three year period
Diagnostic procedures performed among PAH patients measured using the MarketScan database
Retrospective analysis of three year period
Prevalence of comorbidities among PAH patients
Retrospective analysis of three year period
Study Arms (1)
Pediatric PAH patients
US pediatric population with PAH in MarketScan database during the period 2010-2013
Interventions
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
Eligibility Criteria
The study population will be all patients who were born after 1991 and thus under the age of 18 during the years 2010 to 2013 in the MarketScan data. The larger population of patients under age 18 will comprise the general population from which population-based prevalence rates will be derived.
You may qualify if:
- All PAH patients who were in the MarketScan database and who were under age 18 at some time during the years 2010 through 2013
You may not qualify if:
- Not applicable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
Unknown Facility
Boston, Massachusetts, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2015
First Posted
October 15, 2015
Study Start
October 1, 2015
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
February 26, 2016
Record last verified: 2016-02