Side Effects of Pulmonary Hypertension Medications
Patient Reported Side Effects of Pulmonary Hypertension (PH) Medications
1 other identifier
observational
250
1 country
1
Brief Summary
The study seeks to analyze the patient reported effects of pulmonary hypertension medications and compare these with the side effects described on the package inserts. Side effects for these PH medications have been described in the adult population, but have never been described in the pediatric population. This information can better improve patient care and be used to characterize the side effects resultant from these medications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2011
Longer than P75 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
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 3, 2012
CompletedFirst Posted
Study publicly available on registry
April 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedSeptember 16, 2021
September 1, 2021
9.3 years
April 3, 2012
September 15, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Patients Experience Side Effects
Open
Study Arms (1)
Study
Pediatric patients with pulmonary hypertension
Eligibility Criteria
Pediatric patients with pulmonary hypertension seen in the pulmonary hypertension clinic at Stanford Lucile Packard Children's Hospital
You may qualify if:
- pulmonary hypertension
- currently taking at least one of the following PH medications (Bosentan, Epoprostenol, Letairis, Sildenafil, Tadalafil, Treprostinil, Ventaris)
You may not qualify if:
- \>18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lucile Packard Children's Hospital at Stanford
Stanford, California, 94305, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey Feinstein, MD, MPH
Stanford University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
April 3, 2012
First Posted
April 5, 2012
Study Start
August 1, 2011
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
September 16, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share