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OpenTrials
Completed

NCT Number: NCT01571713

Side Effects of Pulmonary Hypertension Medications

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.

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Lucile Packard Children's Hospital at Stanford

Stanford, California, 94305, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Patients Experience Side Effects

    Time frame: Open

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Patient Reported Side Effects of Pulmonary Hypertension (PH) Medications

Important dates

Study start
2011
Primary completion
2020
Study completion
2020
First posted
Apr 5, 2012
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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