Tyvaso Dosing and Titration Evaluation: TyTRATE Registry

NCT ID: NCT01799473

Last Updated: 2015-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

98 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Arterial Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Regents of the University of California

La Jolla, California, United States

Site Status

UCLA Medical Center

Los Angeles, California, United States

Site Status

Southern California Permanente

Pasadena, California, United States

Site Status

Central Coast Chest Consultants

San Luis Obispo, California, United States

Site Status

Pacific Sleep Disorders Center

Stockton, California, United States

Site Status

Prime Healthcare, PC

West Hartford, Connecticut, United States

Site Status

Bay Area Cardiology Associates, PA

Brandon, Florida, United States

Site Status

Florida Lung & Sleep Specialist

Celebration, Florida, United States

Site Status

Jacksonville, Florida, United States

Site Status

Sacred Heart Medical Group

Miramar Beach, Florida, United States

Site Status

Cardiology Consultants

Pensacola, Florida, United States

Site Status

Pensacola Lung Group

Pensacola, Florida, United States

Site Status

Sacred Heart Medical Group

Pensacola, Florida, United States

Site Status

Pediatrix Cardiology Associates

Tampa, Florida, United States

Site Status

Doctors Hospital of Augusta

Augusta, Georgia, United States

Site Status

On Site Clinical Solutions

Cumming, Georgia, United States

Site Status

Duluth Biomedical Research

Duluth, Georgia, United States

Site Status

Gwinnett Consultants in Cardiology

Lawrenceville, Georgia, United States

Site Status

Atlanta Cardiology Consultants

Roswell, Georgia, United States

Site Status

Queens Medical Center - Honolulu

‘Aiea, Hawaii, United States

Site Status

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Site Status

Dor Heart and Vascular Clinic

Gurnee, Illinois, United States

Site Status

Loyola University of Chicago

Maywood, Illinois, United States

Site Status

Advocate Medical Group

Oak Brook, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

Clarian Health Methodist Hospital

Indianapolis, Indiana, United States

Site Status

MedStar Health Institute

Hyattsville, Maryland, United States

Site Status

Pulmonary and Care Associates of Baltimore

Pikesville, Maryland, United States

Site Status

Madison Medical Affiliates

Milwaukee, Michigan, United States

Site Status

Singing River Health System

Pascagoula, Mississippi, United States

Site Status

AZ Perfection Clinical

Union, New Jersey, United States

Site Status

Presbyterian Heart Group

Albuquerque, New Mexico, United States

Site Status

Heart and Lung Associates, PC

Bayside, New York, United States

Site Status

New York Methodist Hospital

Brooklyn, New York, United States

Site Status

Asheville Cardiology Associates

Asheville, North Carolina, United States

Site Status

Sanford Heart Hospital

Fargo, North Dakota, United States

Site Status

Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Midwest Pulmonary & Sleep Research

Dayton, Ohio, United States

Site Status

Southwest General Health Center

Middleburg Heights, Ohio, United States

Site Status

INTEGRIS Baptist Medical Center, Inc

Oklahoma City, Oklahoma, United States

Site Status

The Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, United States

Site Status

WellSpan Health

York, Pennsylvania, United States

Site Status

Maury Regional Medical Center

Columbia, Tennessee, United States

Site Status

Pulmonary Consultants of San Antonio, PA

San Antonio, Texas, United States

Site Status

The Rector and Visitors of the University of Virginia

Charlottesville, Virginia, United States

Site Status

Carilion Medical Center

Roanoke, Virginia, United States

Site Status

Pulmonary & Sleep Research

Spokane, Washington, United States

Site Status

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

The Medical College of Wisconsin, Inc.

Milwaukee, Wisconsin, United States

Site Status

CardioPulmonary Research Center

Guaynabo, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

Other Identifiers

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RIN-PH-404

Identifier Type: -

Identifier Source: org_study_id

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