Completed

A Patient Registry to Observe the Real-World Dosing and Titration of Tyvaso®

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Hypertension, Pulmonary+1

+ Lung Diseases

+ Respiratory Tract Diseases

+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: January 2013
See protocol details

Summary

Principal SponsorUnited Therapeutics
Last updated: March 24, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2013

Actual date on which the first participant was enrolled.

This prospective, observational, multi-center, patient registry will follow patients who are newly initiated on Tyvaso for the treatment of Pulmonary Arterial Hypertension (PAH). Once enrolled, the patients' dose and titration will be followed for the first 6 months of treatment with Tyvaso. A call-center will contact the patients directly at weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24 to review their dose and titration schedule. In addition to patient-reported dosing data, some patient demographic information, will be collected by the investigative site at Baseline.

NCT01799473
Principal SponsorUnited Therapeutics
Last updated: March 24, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

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

98 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hypertension, PulmonaryLung DiseasesRespiratory Tract DiseasesPulmonary Arterial Hypertension

Criteria

2 inclusion criteria required to participate
Are newly prescribed Tyvaso for the treatment of PAH and plan to initiate therapy
Are willing and able to be contacted by the patient call center
2 exclusion criteria prevent from participating
Are currently enrolled in an interventional (non-FDA approved) PH clinical trial
Have previously received Tyvaso

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 52 locations

The Regents of the University of California

La Jolla, United StatesOpen The Regents of the University of California in Google Maps

UCLA Medical Center

Los Angeles, United States

Southern California Permanente

Pasadena, United States

Central Coast Chest Consultants

San Luis Obispo, United States
Completed52 Study Centers