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NCT01571713 Clinical Trial

Side Effects of Pulmonary Hypertension Medications

Pulmonary Hypertension Clinical Trial

Official title:
Patient Reported Side Effects of Pulmonary Hypertension (PH) Medications

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01571713
Other study ID # PHSE22242
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2011
Est. completion date December 2020

Study information
Verified date September 2021
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

As part of standard of care, patients are routinely asked about any symptoms they might be experiencing. This study seeks to quantify these symptoms for research purposes. Participants will be identified through those who attend the pediatric pulmonary hypertension clinic at LPCH. Only children who are currently on one of seven PH medications (Bosentan, Epoprostenol, Letairis, Sildenafil, Tadalafil, Treprostinil, Ventaris) will be approached. Patients who consent to be in the study will answer a brief series of questions pertaining to the presence and duration of their symptoms. These will be correlated to a list of side effects taken from Lexicomp (a medication database).

Recruitment information / eligibility
Status Completed
Enrollment 250
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria: - pulmonary hypertension - currently taking at least one of the following PH medications (Bosentan, Epoprostenol, Letairis, Sildenafil, Tadalafil, Treprostinil, Ventaris) Exclusion Criteria: - >18 years

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Lucile Packard Children's Hospital at Stanford Stanford California

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patients Experience Side Effects Open
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