Tyvaso Dosing and Titration Evaluation: TyTRATE Registry

Completed

• Conditions: Pulmonary Arterial Hypertension

• Registration Number: NCT01799473
• Lead Sponsor: United Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-02-12
• Study First Submitted QC: 2013-02-22
• Study First Posted: 2013-02-26
• Status Verified: 2014-05
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2015-03-20
• Last Update Posted: 2015-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Observe dose changes of Tyvaso over time	6 Months

Trial Locations

Locations (50)

The Regents of the University of California; 🇺🇸 La Jolla, California, United States

UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

Southern California Permanente; 🇺🇸 Pasadena, California, United States

Central Coast Chest Consultants; 🇺🇸 San Luis Obispo, California, United States

Pacific Sleep Disorders Center; 🇺🇸 Stockton, California, United States

Prime Healthcare, PC; 🇺🇸 West Hartford, Connecticut, United States

Bay Area Cardiology Associates, PA; 🇺🇸 Brandon, Florida, United States

Florida Lung & Sleep Specialist; 🇺🇸 Celebration, Florida, United States

Sacred Heart Medical Group; 🇺🇸 Pensacola, Florida, United States

Cardiology Consultants; 🇺🇸 Pensacola, Florida, United States

Scroll for more (40 remaining)