Pulmonary Arterial HypertensionNCT01799473
Tyvaso Dosing and Titration Evaluation: TyTRATE Registry
An observational study of Pulmonary Arterial Hypertension, run by United Therapeutics at 52 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Arterial Hypertension
- How many people
- 98 participants
- Where
- 52 sitesin 2 countries
- Study dates
- Jan 2013to Dec 2014
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients newly initiating on Tyvaso therapy for the treatment of PAH
Who may be able to join
- 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.
Who cannot join
- Have previously received Tyvaso.
- Are currently enrolled in an interventional (non-FDA approved) PH clinical trial.
Trial locations and contacts
52 sites in 2 countries.
52 sites in 2 countries
United States51 sites
Queens Medical Center - Honolulu
‘Aiea, Hawaii, 97601
Presbyterian Heart Group
Albuquerque, New Mexico, 87106
Asheville Cardiology Associates
Asheville, North Carolina, 28803
Doctors Hospital of Augusta
Augusta, Georgia, 30909
Heart and Lung Associates, PC
Bayside, New York, 11361
Bay Area Cardiology Associates, PA
Brandon, Florida, 33511
New York Methodist Hospital
Brooklyn, New York, 11215
Florida Lung & Sleep Specialist
Celebration, Florida, 32747
The Rector and Visitors of the University of Virginia
Charlottesville, Virginia, 22903
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Children's Hospital Medical Center
Cincinnati, Ohio, 45229
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Maury Regional Medical Center
Columbia, Tennessee, 20910
On Site Clinical Solutions
Cumming, Georgia, 30041
Midwest Pulmonary & Sleep Research
Dayton, Ohio, 45459
Duluth Biomedical Research
Duluth, Georgia, 30096
Sanford Heart Hospital
Fargo, North Dakota, 58122
Dor Heart and Vascular Clinic
Gurnee, Illinois, 60031
MedStar Health Institute
Hyattsville, Maryland, 20782
Clarian Health Methodist Hospital
Indianapolis, Indiana, 46202
Study site
Jacksonville, Florida, 32216
The Regents of the University of California
La Jolla, California, 92037
Gwinnett Consultants in Cardiology
Lawrenceville, Georgia, 30046
UCLA Medical Center
Los Angeles, California, 90095
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53705
Loyola University of Chicago
Maywood, Illinois, 60153
Southwest General Health Center
Middleburg Heights, Ohio, 44130
Madison Medical Affiliates
Milwaukee, Michigan, 53212
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
The Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin, 53226
Sacred Heart Medical Group
Miramar Beach, Florida, 32550
Advocate Medical Group
Oak Brook, Illinois, 60523
INTEGRIS Baptist Medical Center, Inc
Oklahoma City, Oklahoma, 73112
Southern California Permanente
Pasadena, California, 91101
Singing River Health System
Pascagoula, Mississippi, 39581
Cardiology Consultants
Pensacola, Florida, 32501
Pensacola Lung Group
Pensacola, Florida, 32504
Sacred Heart Medical Group
Pensacola, Florida, 32504
Methodist Medical Center of Illinois
Peoria, Illinois, 61636
Pulmonary and Care Associates of Baltimore
Pikesville, Maryland, 21117
Carilion Medical Center
Roanoke, Virginia, 24014
Atlanta Cardiology Consultants
Roswell, Georgia, 30076
Pulmonary Consultants of San Antonio, PA
San Antonio, Texas, 78229
Central Coast Chest Consultants
San Luis Obispo, California, 93401
Pulmonary & Sleep Research
Spokane, Washington, 99204
Pacific Sleep Disorders Center
Stockton, California, 95210
Pediatrix Cardiology Associates
Tampa, Florida, 33607
AZ Perfection Clinical
Union, New Jersey, 07083
Prime Healthcare, PC
West Hartford, Connecticut, 06107
The Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, 19096
WellSpan Health
York, Pennsylvania, 17405
About this study
Official title: 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.
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Tyvaso, PAH
- Medical subject headings
- Pulmonary Arterial Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Observe dose changes of Tyvaso over time
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- United Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799473
- Sponsor's protocol ID
- RIN-PH-404
- Status last verified
- May 2014
- First submitted
- 12 Feb 2013
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Patient Registry to Observe the Real-World Dosing and Titration of Tyvaso®
- ClinicalTrials.gov ID
- NCT01799473
- Acronym / sponsor ID
- RIN-PH-404
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Tyvaso, PAH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- United TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 26 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients newly initiating on Tyvaso therapy for the treatment of PAH
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Have previously received Tyvaso.
- Are currently enrolled in an interventional (non-FDA approved) PH clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Observe dose changes of Tyvaso over time
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
52 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension, run by United Therapeutics at 52 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observe dose changes of Tyvaso over time (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2015.