Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Tyvaso Dosing and Titration Evaluation: TyTRATE Registry

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT01799473
First received: February 12, 2013
Last updated: May 21, 2014
Last verified: May 2014

February 12, 2013
May 21, 2014
January 2013
December 2014   (final data collection date for primary outcome measure)
Observe dose changes of Tyvaso over time [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01799473 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
6 Months
Not Provided
Non-Probability Sample

Patients newly initiating on Tyvaso therapy for the treatment of PAH

Pulmonary Arterial Hypertension
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT01799473
RIN-PH-404
No
United Therapeutics
United Therapeutics
Not Provided
Not Provided
United Therapeutics
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP