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Tyvaso Dosing and Titration Evaluation: TyTRATE Registry

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01799473
First Posted: February 26, 2013
Last Update Posted: March 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
United Therapeutics
February 12, 2013
February 26, 2013
March 24, 2015
January 2013
December 2014   (Final data collection date for primary outcome measure)
Observe dose changes of Tyvaso over time [ Time Frame: 6 Months ]
Same as current
Complete list of historical versions of study NCT01799473 on ClinicalTrials.gov Archive Site
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Tyvaso Dosing and Titration Evaluation: TyTRATE Registry
A Patient Registry to Observe the Real-World Dosing and Titration of Tyvaso®

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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Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
6 Months
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Non-Probability Sample
Patients newly initiating on Tyvaso therapy for the treatment of PAH
Pulmonary Arterial Hypertension
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Completed
98
December 2014
December 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   United States
 
 
NCT01799473
RIN-PH-404
No
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United Therapeutics
United Therapeutics
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United Therapeutics
May 2014