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

February 25, 2016 updated by: Bayer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2691

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence rate of PAH (pulmonary arterial hypertension)
Time Frame: Retrospective analysis of three year period
Retrospective analysis of three year period
Prevalence rate of PAH
Time Frame: Retrospective analysis of three year period
Retrospective analysis of three year period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Retrospective analysis of three year period
Diagnostic procedures performed among PAH patients measured using the MarketScan database
Time Frame: Retrospective analysis of three year period
Retrospective analysis of three year period
Prevalence of comorbidities among PAH patients
Time Frame: Retrospective analysis of three year period
Retrospective analysis of three year period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

October 13, 2015

First Submitted That Met QC Criteria

October 14, 2015

First Posted (Estimate)

October 15, 2015

Study Record Updates

Last Update Posted (Estimate)

February 26, 2016

Last Update Submitted That Met QC Criteria

February 25, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18515

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension, Pulmonary

Clinical Trials on Assigned pulmonary hypertension medication

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe