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

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ClinicalTrials.gov Identifier: NCT02576002
Recruitment Status : Completed
First Posted : October 15, 2015
Last Update Posted : February 26, 2016
Sponsor:
Information provided by (Responsible Party):
Bayer

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

Condition or disease Intervention/treatment
Hypertension, Pulmonary Drug: Assigned pulmonary hypertension medication

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Study Type : Observational
Actual Enrollment : 2691 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Study to Estimate the Incidence and Prevalence and Treatment Patterns of Pediatric Pulmonary Hypertension in the US
Study Start Date : October 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016


Group/Cohort Intervention/treatment
Pediatric PAH patients
US pediatric population with PAH in MarketScan database during the period 2010-2013
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




Primary Outcome Measures :
  1. Incidence rate of PAH (pulmonary arterial hypertension) [ Time Frame: Retrospective analysis of three year period ]
  2. Prevalence rate of PAH [ Time Frame: Retrospective analysis of three year period ]

Secondary Outcome Measures :
  1. Assigned drug treatment for PAH measured using the MarketScan database [ Time Frame: Retrospective analysis of three year period ]
    Description of pulmonary hypertension-targeted drugs prescribed in the study population and changes during the study period

  2. Diagnostic procedures performed among PAH patients measured using the MarketScan database [ Time Frame: Retrospective analysis of three year period ]
  3. Prevalence of comorbidities among PAH patients [ Time Frame: Retrospective analysis of three year period ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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:

Not applicable


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02576002


Locations
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United States, Massachusetts
Boston, Massachusetts, United States
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02576002    
Other Study ID Numbers: 18515
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: February 26, 2016
Last Verified: February 2016
Keywords provided by Bayer:
Pulmonary Arterial Hypertension
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases