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Side Effects of Pulmonary Hypertension Medications

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ClinicalTrials.gov Identifier: NCT01571713
Recruitment Status : Active, not recruiting
First Posted : April 5, 2012
Last Update Posted : March 5, 2020
Sponsor:
Information provided by (Responsible Party):
Jeffrey A. Feinstein, Stanford University

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.

Condition or disease
Pulmonary Hypertension

Detailed 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).

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Patient Reported Side Effects of Pulmonary Hypertension (PH) Medications
Study Start Date : August 2011
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Study
Pediatric patients with pulmonary hypertension



Primary Outcome Measures :
  1. Patients Experience Side Effects [ Time Frame: Open ]


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
Pediatric patients with pulmonary hypertension seen in the pulmonary hypertension clinic at Stanford Lucile Packard Children's Hospital
Criteria

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

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): NCT01571713


Locations
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United States, California
Lucile Packard Children's Hospital at Stanford
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Jeffrey Feinstein, MD, MPH Stanford University
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Responsible Party: Jeffrey A. Feinstein, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01571713    
Other Study ID Numbers: PHSE22242
First Posted: April 5, 2012    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases