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
  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: December 2014
Estimated Primary Completion Date: December 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01799473

  Hide Study Locations
Locations
United States, California
The Regents of the University of California
La Jolla, California, United States, 92037
UCLA Medical Center
Los Angeles, California, United States, 90095
Southern California Permanente
Pasadena, California, United States, 91101
Central Coast Chest Consultants
San Luis Obispo, California, United States, 93401
Pacific Sleep Disorders Center
Stockton, California, United States, 95210
United States, Connecticut
Prime Healthcare, PC
West Hartford, Connecticut, United States, 06107
United States, Florida
Bay Area Cardiology Associates, PA
Brandon, Florida, United States, 33511
Florida Lung & Sleep Specialist
Celebration, Florida, United States, 32747
Jacksonville, Florida, United States, 32216
Sacred Heart Medical Group
Miramar Beach, Florida, United States, 32550
Sacred Heart Medical Group
Pensacola, Florida, United States, 32504
Pensacola Lung Group
Pensacola, Florida, United States, 32504
Cardiology Consultants
Pensacola, Florida, United States, 32501
Pediatrix Cardiology Associates
Tampa, Florida, United States, 33607
United States, Georgia
Doctors Hospital of Augusta
Augusta, Georgia, United States, 30909
On Site Clinical Solutions
Cumming, Georgia, United States, 30041
Duluth Biomedical Research
Duluth, Georgia, United States, 30096
Gwinnett Consultants in Cardiology
Lawrenceville, Georgia, United States, 30046
Atlanta Cardiology Consultants
Roswell, Georgia, United States, 30076
United States, Hawaii
Queens Medical Center - Honolulu
Aiea, Hawaii, United States, 97601
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Dor Heart and Vascular Clinic
Gurnee, Illinois, United States, 60031
Loyola University of Chicago
Maywood, Illinois, United States, 60153
Advocate Medical Group
Oakbrook, Illinois, United States, 60523
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
United States, Indiana
Clarian Health Methodist Hospital
Indianapolis, Indiana, United States, 46202
United States, Maryland
MedStar Health Institute
Hyattsville, Maryland, United States, 20782
Pulmonary and Care Associates of Baltimore
Pikesville, Maryland, United States, 21117
United States, Michigan
Madison Medical Affiliates
Milwaukee, Michigan, United States, 53212
United States, Mississippi
Singing River Health System
Pascagoula, Mississippi, United States, 39581
United States, New Jersey
AZ Perfection Clinical
Union, New Jersey, United States, 07083
United States, New Mexico
Presbyterian Heart Group
Albuquerque, New Mexico, United States, 87106
United States, New York
Heart and Lung Associates, PC
Bayside, New York, United States, 11361
New York Methodist Hospital
Brooklyn, New York, United States, 11215
United States, North Carolina
Asheville Cardiology Associates
Asheville, North Carolina, United States, 28803
United States, North Dakota
Sanford Heart Hospital
Fargo, North Dakota, United States, 58122
United States, Ohio
Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Midwest Pulmonary & Sleep Research
Dayton, Ohio, United States, 45459
Southwest General Health Center
Middleburg Heights, Ohio, United States, 44130
United States, Oklahoma
INTEGRIS Baptist Medical Center, Inc
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
The Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, United States, 19096
WellSpan Health
York, Pennsylvania, United States, 17405
United States, Tennessee
Maury Regional Medical Center
Columbia, Tennessee, United States, 20910
United States, Texas
Pulmonary Consultants of San Antonio, PA
San Antonio, Texas, United States, 78229
United States, Virginia
The Rector and Visitors of the University of Virginia
Charlottesville, Virginia, United States, 22903
Carilion Medical Center
Roanoke, Virginia, United States, 24014
United States, Washington
Pulmonary & Sleep Research
Spokane, Washington, United States, 99204
United States, Wisconsin
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States, 53705
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
The Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin, United States, 53226
Puerto Rico
CardioPulmonary Research Center
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: May 21, 2014
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 August 01, 2014