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OpenTrials
Completed

NCT Number: NCT01799473

Tyvaso Dosing and Titration Evaluation: TyTRATE Registry

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

CardioPulmonary Research Center, Guaynabo, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. Observe dose changes of Tyvaso over time

    Time frame: 6 Months

Sponsors and collaborators

Lead sponsor

United Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 26, 2013
Registry last updated
Mar 24, 2015

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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