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Clinical Trials/NCT01799473
NCT01799473
Completed
Not Applicable

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

United Therapeutics50 sites in 2 countries98 target enrollmentJanuary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Arterial Hypertension
Sponsor
United Therapeutics
Enrollment
98
Locations
50
Primary Endpoint
Observe dose changes of Tyvaso over time
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
December 2014
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Have previously received Tyvaso.
  • Are currently enrolled in an interventional (non-FDA approved) PH clinical trial.

Outcomes

Primary Outcomes

Observe dose changes of Tyvaso over time

Time Frame: 6 Months

Study Sites (50)

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