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Tyvaso Dosing and Titration Evaluation: TyTRATE Registry

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ClinicalTrials.gov Identifier: NCT01799473
Recruitment Status : Completed
First Posted : February 26, 2013
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
United Therapeutics

Study Description
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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.


Condition or disease
Pulmonary Arterial Hypertension

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 98 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: A Patient Registry to Observe the Real-World Dosing and Titration of Tyvaso®
Study Start Date : January 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Observe dose changes of Tyvaso over time [ Time Frame: 6 Months ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients newly initiating on Tyvaso therapy for the treatment of PAH
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799473


Locations
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Sponsors and Collaborators
United Therapeutics
More Information
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Additional Information:

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Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT01799473    
Other Study ID Numbers: RIN-PH-404
First Posted: February 26, 2013    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: May 2014
Keywords provided by United Therapeutics:
Tyvaso
PAH
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases