Tyvaso Dosing and Titration Evaluation: TyTRATE Registry

This study is currently recruiting participants.
Verified December 2013 by United Therapeutics
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT01799473
First received: February 12, 2013
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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
Pulmonary Arterial Hypertension

Study Type: Observational [Patient Registry]
Study Design: 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®

Resource links provided by NLM:


Further study details as provided by United Therapeutics:

Primary Outcome Measures:
  • Observe dose changes of Tyvaso over time [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01799473

Contacts
Contact: Laura Moore Laura.Moore@ubc.com

  Hide Study Locations
Locations
United States, California
The Regents of the University of California Recruiting
La Jolla, California, United States, 92037
UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Southern California Permanente Recruiting
Pasadena, California, United States, 91101
Central Coast Chest Consultants Recruiting
San Luis Obispo, California, United States, 93401
Pacific Sleep Disorders Center Recruiting
Stockton, California, United States, 95210
United States, Connecticut
Prime Healthcare, PC Recruiting
West Hartford, Connecticut, United States, 06107
United States, Florida
Bay Area Cardiology Associates, PA Recruiting
Brandon, Florida, United States, 33511
Florida Lung & Sleep Specialist Recruiting
Celebration, Florida, United States, 32747
Recruiting
Jacksonville, Florida, United States, 32216
Sacred Heart Medical Group Recruiting
Miramar Beach, Florida, United States, 32550
Sacred Heart Medical Group Recruiting
Pensacola, Florida, United States, 32504
Pensacola Lung Group Recruiting
Pensacola, Florida, United States, 32504
Cardiology Consultants Recruiting
Pensacola, Florida, United States, 32501
Pediatrix Cardiology Associates Recruiting
Tampa, Florida, United States, 33607
United States, Georgia
Doctors Hospital of Augusta Recruiting
Augusta, Georgia, United States, 30909
On Site Clinical Solutions Recruiting
Cumming, Georgia, United States, 30041
Duluth Biomedical Research Recruiting
Duluth, Georgia, United States, 30096
Gwinnett Consultants in Cardiology Recruiting
Lawrenceville, Georgia, United States, 30046
Atlanta Cardiology Consultants Recruiting
Roswell, Georgia, United States, 30076
United States, Hawaii
Queens Medical Center - Honolulu Recruiting
Aiea, Hawaii, United States, 97601
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Dor Heart and Vascular Clinic Recruiting
Gurnee, Illinois, United States, 60031
Loyola University of Chicago Recruiting
Maywood, Illinois, United States, 60153
Advocate Medical Group Recruiting
Oakbrook, Illinois, United States, 60523
Methodist Medical Center of Illinois Recruiting
Peoria, Illinois, United States, 61636
United States, Indiana
Clarian Health Methodist Hospital Recruiting
Indianapolis, Indiana, United States, 46202
United States, Maryland
MedStar Health Institute Recruiting
Hyattsville, Maryland, United States, 20782
Pulmonary and Care Associates of Baltimore Recruiting
Pikesville, Maryland, United States, 21117
United States, Michigan
Madison Medical Affiliates Recruiting
Milwaukee, Michigan, United States, 53212
United States, Mississippi
Singing River Health System Recruiting
Pascagoula, Mississippi, United States, 39581
United States, New Jersey
AZ Perfection Clinical Recruiting
Union, New Jersey, United States, 07083
United States, New Mexico
Presbyterian Heart Group Recruiting
Albuquerque, New Mexico, United States, 87106
United States, New York
Heart and Lung Associates, PC Recruiting
Bayside, New York, United States, 11361
New York Methodist Hospital Recruiting
Brooklyn, New York, United States, 11215
United States, North Carolina
Asheville Cardiology Associates Recruiting
Asheville, North Carolina, United States, 28803
United States, North Dakota
Sanford Heart Hospital Recruiting
Fargo, North Dakota, United States, 58122
United States, Ohio
Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
The Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Midwest Pulmonary & Sleep Research Recruiting
Dayton, Ohio, United States, 45459
Southwest General Health Center Recruiting
Middleburg Heights, Ohio, United States, 44130
United States, Oklahoma
INTEGRIS Baptist Medical Center, Inc Recruiting
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
The Lankenau Institute for Medical Research Recruiting
Wynnewood, Pennsylvania, United States, 19096
WellSpan Health Recruiting
York, Pennsylvania, United States, 17405
United States, Tennessee
Maury Regional Medical Center Recruiting
Columbia, Tennessee, United States, 20910
United States, Texas
Pulmonary Consultants of San Antonio, PA Recruiting
San Antonio, Texas, United States, 78229
United States, Virginia
The Rector and Visitors of the University of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Carilion Medical Center Recruiting
Roanoke, Virginia, United States, 24014
United States, Washington
Pulmonary & Sleep Research Recruiting
Spokane, Washington, United States, 99204
United States, Wisconsin
University of Wisconsin School of Medicine and Public Health Recruiting
Madison, Wisconsin, United States, 53705
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
The Medical College of Wisconsin, Inc. Recruiting
Milwaukee, Wisconsin, United States, 53226
Puerto Rico
CardioPulmonary Research Center Recruiting
Guaynabo, Puerto Rico, 00968
Sponsors and Collaborators
United Therapeutics
  More Information

No publications provided

Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT01799473     History of Changes
Other Study ID Numbers: RIN-PH-404
Study First Received: February 12, 2013
Last Updated: December 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by United Therapeutics:
Tyvaso
PAH

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 14, 2014