Study of Incidence of Respiratory Tract Adverse Events in Patients Treated With Tyvaso® Compared to Other FDA Approved Pulmonary Arterial Hypertension (PAH) Therapies (Aspire)
This study is currently recruiting participants.
Verified October 2012 by United Therapeutics
Sponsor:
United Therapeutics
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT01266265
First received: December 22, 2010
Last updated: October 5, 2012
Last verified: October 2012
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Purpose
A surveillance of respiratory tract related adverse events in patients treated with Tyvaso®(treprostinil) Inhalation Solution versus other FDA approved therapies
| Condition | Intervention |
|---|---|
|
Pulmonary Arterial Hypertension |
Drug: inhaled prostacyclin Drug: prostacyclin Drug: subcutaneous and intravenous prostacyclin Drug: oral ERA Drug: oral PDE5 inhibitors |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Postmarketing Observational Study to Assess Respiratory Tract Adverse Events in Pulmonary Arterial Hypertension Patients Treated With Tyvaso®(Treprostinil) Inhalation Solution |
Resource links provided by NLM:
Genetics Home Reference related topics:
pulmonary arterial hypertension
MedlinePlus related topics:
High Blood Pressure
Drug Information available for:
Epoprostenol
Epoprostenol sodium
Iloprost
Treprostinil
Sildenafil
Bosentan
Tadalafil
Sildenafil citrate
Ambrisentan
Treprostinil sodium
U.S. FDA Resources
Further study details as provided by United Therapeutics:
Primary Outcome Measures:
- Describe the type and incidence of oro-/nasopharyngeal and pulmonary adverse events that may be associated with current or recent treatment with Tyvaso for PAH [ Time Frame: Follow-up every 3 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Compare the incidence of selected oro-/nasopharyngeal and pulmonary adverse events in patients treated with Tyvaso for PAH with patients not treated with Tyvaso for PAH [ Time Frame: Follow-up every 3 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 1320 |
| Study Start Date: | December 2010 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Tyvaso |
Drug: inhaled prostacyclin
Tyvaso
Other Name: treprostinil
|
|
Control
Any other FDA approved therapies for PAH
|
Drug: inhaled prostacyclin
As prescribed by the physician
Other Name: iloprost, Ventavis
Drug: prostacyclin
As prescribed by the physician
Other Name: epoprostenol sodium, Flolan
Drug: subcutaneous and intravenous prostacyclin
As prescribed by physician
Other Name: treprostinil , Remodulin
Drug: oral ERA
As prescribed by physician
Other Names:
Drug: oral PDE5 inhibitors
As prescribed by physician
Other Names:
|
Detailed Description:
A post marketing surveillance to determine the type and incidence of oro/nasopharyngeal or pulmonary adverse events that may occur in patients treated with commercially available Tyvaso®(treprostinil) Inhalation Solution. A comparison will be made to the type and incidence of events in patients receiving other FDA approved therapies for pulmonary arterial hypertension, as a control measure.
Eligibility| Ages Eligible for Study: | 1 Year and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
community centers, academic institutions
Criteria
Inclusion Criteria:
- Clinical diagnosis of PAH, WHO GROUP I
- Prescribed and is currently receiving Tyvaso and/or other FDA-approved therapy for the treatment of PAH
- Willing and able to provide written informed consent
Exclusion Criteria:
- Previous initiation and permanent discontinuation of Tyvaso
- Participation in an investigational clinical drug or device trial within 30 days of enrollment
- Current or past diagnosis of lung neoplasm
- Active gastrointestinal or pulmonary bleed at enrollment
- Planned surgical intervention for treatment of PAH e.g., atrial septostomy or transplant
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01266265
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| United States, Alabama | |
| Cardiovascular Associates, P.C. | Recruiting |
| Birmingham, Alabama, United States, 35213 | |
| Contact: Donna Cole 205-599-6385 dcole@cvapc.com | |
| Principal Investigator: Barry Rayburn, MD | |
| The University of Alabama at Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: Rachel Culbreth 205-934-8767 chfnurse@cardiology.uab.edu | |
| Principal Investigator: Robert C. Bourge, MD | |
| University of South Alabama | Recruiting |
| Mobile, Alabama, United States, 36693 | |
| Contact: Jennifer Smith 251-471-7291 jksmith@usouthal.edu | |
| Principal Investigator: Karen Fagan, MD | |
| United States, Arizona | |
| Arizona Pulmonary Specialists, LTD | Recruiting |
| Phoenix, Arizona, United States, 85013 | |
| Contact: Jeremy Feldman, MD 602-274-7195 | |
| Principal Investigator: Jeremy Feldman, MD | |
| United States, California | |
| Berkeley Cardiovascular Medical Group | Recruiting |
| Berkeley, California, United States, 94705 | |
| Contact: Eileen Healy, NP 510-204-1691 healye@bcvmg.com | |
| Principal Investigator: Luisa Munoz, MD | |
| Cedars-Sinai Heart Institute | Recruiting |
| Beverly Hills, California, United States, 90211 | |
| Contact: Tiffany Daun 310-248-7129 tiffany.daun@cshs.org | |
| Principal Investigator: Antoine Hage, MD | |
| University California San Francisco | Recruiting |
| Fresno, California, United States, 93721 | |
| Contact: Sonja Garcia 559-459-4042 SGarcia@fresno.ucsf.edu | |
| Principal Investigator: Vijay Balasubramanian, MD | |
| University of Southern California | Recruiting |
| Los Angeles, California, United States, 90033 | |
| Contact: Lynn Fukushima 323-442-9580 Lynn.Fukushima@med.usc.edu | |
| Principal Investigator: Sivagini Ganesh, MD | |
| West Los Angeles VA Healthcare Center | Recruiting |
| Los Angeles, California, United States, 90073 | |
| Contact: Wendy Hill 310-268-4314 Wendy.Hill@va.gov | |
| Principal Investigator: Shelly Shapiro, MD | |
| University of California, San Francisco | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Leslie Ziani 415-476-4014 lziani@medicine.ucsf.edu | |
| Principal Investigator: Dana McGlothlin, MD | |
| Paloma Medical Group | Recruiting |
| San Juan Capistrano, California, United States, 92675 | |
| Contact: Theresa Schwarz, RN 949-443-4114 rn1232@hotmail.com | |
| Principal Investigator: Michael Rovzar, MD | |
| Santa Barbara Cottage Hospital | Recruiting |
| Santa Barbara, California, United States, 93105 | |
| Contact: Zorina Schultz 805-569-7461 zschultz@sbch.org | |
| Principal Investigator: Jeffery Sager, MD | |
| Stanford Hospital and Clinics | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Val Scott vscott@stanford.edu | |
| Principal Investigator: Roham Zamanian, MD | |
| United States, Colorado | |
| Children's Hospital Denver | Recruiting |
| Denver, Colorado, United States, 80045 | |
| Contact: Kathleen Miller-Reed, RN 720-777-6427 Miller-Reed.Kathleen@tchden.org | |
| Principal Investigator: D. Dunbar Ivy, MD | |
| Western States Clinical Research, Inc. | Recruiting |
| Wheat Ridge, Colorado, United States, 80033 | |
| Contact: Cheri Casey 303-940-9773 cheri@wscrinc.com | |
| Principal Investigator: Robert Benkert, MD | |
| United States, Florida | |
| St. Francis Sleep Allergy & Lung | Recruiting |
| Clearwater, Florida, United States, 33765 | |
| Contact: Ann Gove 727-447-3000 ext 222 agove@stfrancismed.com | |
| Principal Investigator: Frank Averill, MD | |
| University of Florida | Recruiting |
| Gainesville, Florida, United States, 32610 | |
| Contact: Christina Eagan 352-273-8990 Christina.Eagan@medicine.ufl.edu | |
| Principal Investigator: Hassan Alnuaimat, MD | |
| University of Florida College of Medicine Jacksonville | Recruiting |
| Jacksonville, Florida, United States, 32209 | |
| Contact: Minal Patel 904-244-1106 Minal.Patel@jax.ufl.edu | |
| Principal Investigator: Abubakr Bawja, MD | |
| Mayo Clinic Jacksonville | Recruiting |
| Jacksonville, Florida, United States, 32224 | |
| Contact: Shannon Kennedy 904-953-7439 kennedy.shannon@mayo.edu | |
| Principal Investigator: Charles Burger, MD | |
| Pulmonary and Critical Care Associates | Recruiting |
| Jacksonville, Florida, United States, 32204 | |
| Contact: Ronni Wetmore 904-366-3738 rwetmore@paccaweb.com | |
| Principal Investigator: Mitchell Rothstein, MD | |
| Miami Center for Cardiovascular Disease | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Adriana Silva 786-250-9399 adriana0513.as@gmail.com | |
| Principal Investigator: Javier Jimenez, MD | |
| Mount Sinai Medical Center | Recruiting |
| Miami Beach, Florida, United States, 33140 | |
| Contact: Helen Garcia 305-674-2162 helen.garcia@msmc.com | |
| Principal Investigator: Esteban Escolar, MD | |
| Central Florida Pulmonary Group, P.A. | Recruiting |
| Orlando, Florida, United States, 32806 | |
| Contact: Linda Tilme ltilme@gcrm.com | |
| Principal Investigator: Daniel Layish, MD | |
| Orlando Heart Center | Recruiting |
| Orlando, Florida, United States, 32806 | |
| Contact: Sally Hewit 407-650-1348 SHewit@orlandoheart.com | |
| Principal Investigator: James Tarver, III, MD | |
| Cleveland Clinic Florida | Recruiting |
| Weston, Florida, United States, 33331 | |
| Contact: Norma Jean Barton bartonn2@ccf.org | |
| Principal Investigator: Franck F Rahaghi, MD | |
| United States, Georgia | |
| Emory University School of Medicine | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Jane Gillespie 404-712-8204 jegille@emory.edu | |
| Principal Investigator: Micah Fisher, MD | |
| Georgia Lung Associates, PC | Recruiting |
| Austell, Georgia, United States, 30106 | |
| Contact: Stacy Beasley 770-745-1404 ext 4 sbeasley_gcr@yahoo.com | |
| Principal Investigator: Chad Miller, MD | |
| United States, Illinois | |
| Northwestern Medical Center | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Jinal Gangar, MBBS,MPH 312-695-2269 drjinalgangar@northwestern.edu | |
| Principal Investigator: Michael Cuttica, MD | |
| University of Illinois at Chicago | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Nancy Casanova 312-355-5934 ngcasan@uic.edu | |
| Principal Investigator: Roberto Machado, MD | |
| Rush University Medical Center | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Joyce Brown 312-942-6771 Joyce_Brown@rush.edu | |
| Principal Investigator: Rajive Tandon, MD | |
| Midwest Heart Foundation | Recruiting |
| Oakbrook Terrace, Illinois, United States, 60181 | |
| Contact: Debbie Heidenreich 630-873-3406 dheidenreich@midwestheart.org | |
| Principal Investigator: Maria Rosa Costanzo, MD | |
| United States, Indiana | |
| Indiana University Hospital | Recruiting |
| Carmel, Indiana, United States, 46032 | |
| Contact: Betty Logan, MD 317-688-3846 blogan@iuhealth.org | |
| Principal Investigator: William Harvey, MD | |
| United States, Iowa | |
| University of Iowa | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Tiffany Kriegel 319-384-6558 tiffany-kriegel@uiowa.edu | |
| Principal Investigator: Sif Hansdottir, MD | |
| Mercy Hospital | Recruiting |
| Iowa City, Iowa, United States, 52245 | |
| Contact: Amy Becker, RN 319-688-7026 Amy.Becker@mercyic.org | |
| Principal Investigator: Andrew Ashby, MD | |
| United States, Kansas | |
| University of Kansas Medical Center | Recruiting |
| Kansas City, Kansas, United States, 66160 | |
| Contact: Stephanie Thomas-Dodson 913-588-4022 sthomas-dodson@kumc.edu | |
| Principal Investigator: Tim Williamson, MD | |
| United States, Kentucky | |
| Kentuckiana Pulmonary Associates | Recruiting |
| Louisville, Kentucky, United States, 40202 | |
| Contact: Kim Hobbs 502-587-8000 khobbs@kpadocs.com | |
| Principal Investigator: Wes John McConnell, MD | |
| United States, Maryland | |
| Johns Hopkins University | Recruiting |
| Baltimore, Maryland, United States, 21205 | |
| Contact: Jude Aidam jaidam1@jhu.edu | |
| Principal Investigator: Stephen Mathai, MD | |
| University of Maryland | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Faith Janowick 410-328-4433 fjanowic@medicine.umaryland.edu | |
| Principal Investigator: Myung Park, MD | |
| United States, Massachusetts | |
| Tufts - New England Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02111 | |
| Contact: Karen Visnaw, RN 617-636-1334 kvisnaw@tuftsmedicalcenter.org | |
| Principal Investigator: Nicholas Hill, MD | |
| Brigham and Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Laurie Lawler, RN 617-525-9731 LLAWLER@PARTNERS.ORG | |
| Principal Investigator: Aaron Waxman, MD | |
| United States, Michigan | |
| Henry Ford Health System | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Marcie Major 313-916-2433 MMAJOR1@hfhs.org | |
| Principal Investigator: Hector Cajigas, MD | |
| William Beaumont Hospital | Recruiting |
| Troy, Michigan, United States, 48085 | |
| Contact: Coleen Tessmar 248-964-8524 ctessmar@beaumont.edu | |
| Principal Investigator: Samuel Allen, MD | |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Louise Durst louise.durst@mayo.edu | |
| Principal Investigator: Robert Frantz, MD | |
| United States, Nebraska | |
| Nebraska Pulmonary Specialties, LLC | Recruiting |
| Lincoln, Nebraska, United States, 68506 | |
| Contact: Lisa Whisenhut 402-483-8684 lisaw@npsllc.org | |
| Principal Investigator: Jeffrey Jarrett, MD | |
| United States, New Jersey | |
| Hackensack University Medical Center | Recruiting |
| Hackensack, New Jersey, United States, 07601 | |
| Contact: Diane Agar DAgar@HackensackUMC.org | |
| Principal Investigator: Robert Berkowitz, MD | |
| UMDNJ - Robert Wood Johnson Medical Center Clinical Research Center | Recruiting |
| New Brunswick, New Jersey, United States, 08903 | |
| Contact: Deborah McCloskey mcclosda@umdnj.edu | |
| Principal Investigator: Vivien Hsu, MD | |
| Newark Beth Israel Medical Center | Recruiting |
| Newark, New Jersey, United States, 07112 | |
| Contact: Juliet Williams 973-926-8578 JuWilliams@SBHCS.com | |
| Principal Investigator: Sean Studer, MD | |
| United States, New York | |
| SUNY Stony Brook University Medical Center | Recruiting |
| Islandia, New York, United States, 11790 | |
| Contact: Jacqueline Skarre jacqueline.skarre@stonybrook.edu | |
| Principal Investigator: Paul Strachan, MD | |
| Winthrop Pulmonary Associates | Recruiting |
| Mineola, New York, United States, 11501 | |
| Contact: Kim Byrnes, LPN kbyrnes@winthrop.org | |
| Principal Investigator: Shilpa Ann DeSouza, MD | |
| North Shore - Long Island Jewish Health System | Recruiting |
| New Hyde Park, New York, United States, 11040 | |
| Contact: Rebecca Miller 516-465-5447 rmiller6@nshs.edu | |
| Principal Investigator: Arunabh Talwar, MD | |
| Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Katherine Whee 212-305-4436 kl2454@columbia.edu | |
| Principal Investigator: Erika Berman-Rosenzweig, MD | |
| St. Luke's-Roosevelt Hospital Center | Recruiting |
| New York, New York, United States, 10019 | |
| Contact: Lori Tartell 212-523-5471 LTARTELL@CHPNET.ORG | |
| Principal Investigator: Ruth Minkin, MD | |
| Mary M Parkes Center | Recruiting |
| Rochester, New York, United States, 14623 | |
| Contact: Toni Heininger 585-486-0147 ext 123 antonia_heininger@urmc.rochester.edu | |
| Principal Investigator: R. James White, MD | |
| Pulmonary Health Physicians | Recruiting |
| Syracuse, New York, United States, 13210 | |
| Contact: Cathy Fogus 315-234-0816 cathy.fogus@cnylungs.com | |
| Principal Investigator: Sherif El Bayadi, MD | |
| United States, North Carolina | |
| University of North Carolina at Chapel Hill | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: Sarah McGee 919-966-2531 smcgee@med.unc.edu | |
| Principal Investigator: Hubert Ford, MD | |
| Pinehurst Medical Clinic | Recruiting |
| Pinehurst, North Carolina, United States, 28374 | |
| Contact: Brenda Sanders 910-235-3142 basanders@pinehurstmedical.com | |
| Principal Investigator: Michael Pritchett, MD | |
| Wake Forest University Health Sciences | Recruiting |
| Winston-Salem, North Carolina, United States, 27157 | |
| Contact: Gayle Marterre 336-716-0573 gmarterr@wakehealth.edu | |
| Principal Investigator: Rodolfo Pascual, MD | |
| United States, Ohio | |
| Akron General Hospital | Recruiting |
| Akron, Ohio, United States, 44302 | |
| Contact: Debbie Hudock 330-344-1570 dhudock@agmc.org | |
| Principal Investigator: Michael Passero, MD | |
| University of Cincinnati | Recruiting |
| Cincinnati, Ohio, United States, 45267-0564 | |
| Contact: Tammy Roads 513-558-2148 roadst@ucmail.uc.edu | |
| Principal Investigator: Jean Elwing, MD | |
| University Hospitals of Cleveland | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: David Haney 216-844-2381 david.haney@uhhospitals.org | |
| Principal Investigator: Robert Schliz, MD | |
| Davis Heart and Lung Research Institute | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Laura Yamokoski 614-247-7793 Laura.Yamokoski@osumc.edu | |
| Principal Investigator: Veronica Franco, MD | |
| Mercy Fairfield Hospital | Recruiting |
| Fairfield, Ohio, United States, 45014 | |
| Contact: MaryLou Sauer 513-603-8236 smdsauer@yahoo.com | |
| Principal Investigator: Lynne Wagoner, MD | |
| United States, Oregon | |
| OHSU-Oregon Health and Science University | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Kristen Baptiste baptiste@ohsu.edu | |
| Principal Investigator: Akram Khan, MD | |
| Legacy Pulmonary Northwest | Recruiting |
| Portland, Oregon, United States, 97210 | |
| Contact: Tamara Mayfield 503-413-7945 TMayfiel@LHS.ORG | |
| Principal Investigator: Catherine Markin, MD | |
| Oregon Clinic, PC | Recruiting |
| Portland, Oregon, United States, 97220 | |
| Contact: Meg Day 503-963-3182 mday@orclinic.com | |
| Principal Investigator: Rhett Cummings, MD | |
| United States, Pennsylvania | |
| Penn State Milton S. Hershey Medical Center | Recruiting |
| Hershey, Pennsylvania, United States, 17033 | |
| Contact: Robert Vender, MD rvender@hmc.psu.edu | |
| Principal Investigator: Robert Vender, MD | |
| Thomas Jefferson University | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Paul Park 215-503-4070 paul.park@jefferson.edu | |
| Principal Investigator: Michael Scharf, MD | |
| Children's Hospital of Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Jeannie Acampora acampora@email.chop.edu | |
| Principal Investigator: Brian Hanna, MD | |
| Temple University | Recruiting |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Contact: Melody Santiago Melody.Santiago@tuhs.temple.edu | |
| Principal Investigator: Shelia Weaver, MD | |
| University of Pennsylvania Health System | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Christine Malloy 215-513-2999 christine.malloy@uphs.upenn.edu | |
| Principal Investigator: Eduardo Rame, MD | |
| Allegheny General Hospital | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| Contact: Pranav Ravi 412-359-6691 pravi@wpahs.org | |
| Principal Investigator: Raymond Benza, MD | |
| University of Pittsburgh Medical Center | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213-2582 | |
| Contact: Paula M. McGrath 412-692-2769 McGrathPM@upmc.edu | |
| Principal Investigator: Michael Mathier, MD | |
| Berks Schuylkill Respiratory Specialists, Ltd. | Recruiting |
| Wyomissing, Pennsylvania, United States, 19610 | |
| Contact: Lisa Hill 610-685-5864 ext 166 lhill@lungmd.net | |
| Principal Investigator: Alec Platt, MD | |
| United States, Rhode Island | |
| Rhode Island Hospital | Recruiting |
| Providence, Rhode Island, United States, 02903 | |
| Contact: Barbara Smithson 401-444-9097 BSmithson@Lifespan.org | |
| Principal Investigator: James Klinger, MD | |
| United States, South Carolina | |
| Lexington Pulmonary and Critical Care | Recruiting |
| Lexington, South Carolina, United States, 29072 | |
| Contact: Christina Derienzo, RN 803-394-7279 cderienzo@lexpcc.net | |
| Principal Investigator: Donald Elton, MD | |
| United States, Tennessee | |
| MD Total Care, PLLC | Recruiting |
| Chattanooga, Tennessee, United States, 37419 | |
| Contact: Eva Malaspino 423-710-3864 clinicaltrails_MDTC@earthlink.net | |
| Principal Investigator: Michael Czarnecki, MD | |
| Summit Medical Group | Recruiting |
| Knoxville, Tennessee, United States, 37909 | |
| Contact: Monica Goins 423-989-3105 mgoins@pmg-research.com | |
| Principal Investigator: John Swisher, MD | |
| Vanderbilt University Medical Center | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Shelly Gonzalez 615-343-8277 rochelle.gonzalez@Vanderbilt.Edu | |
| Principal Investigator: Ivan Robbins, MD | |
| United States, Texas | |
| UT Southwestern Medical Center | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Yvonne Pena 214-645-7148 Yvonne.Pena@UTSouthwestern.edu | |
| Principal Investigator: Sonja Bartolome, MD | |
| Texas Children's Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Charles Sellers 832-822-4790 cxseller@texaschildrens.org | |
| Principal Investigator: Fadel Ruiz, MD | |
| University of Texas Health Science Center at Houston | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Kristi Baysinger 713-500-6851 Kristi.L.Baysinger@uth.tmc.edu | |
| Principal Investigator: Bela Patel, MD | |
| Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Jennifer L Lee 713-798-2400 jllee@bcm.edu | |
| Principal Investigator: Zeenat Safdar, MD | |
| University of Texas Health Science Center at San Antonio | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Regina Whitener, RN 210-617-5300 ext 14549 WHITENER@uthscsa.edu | |
| Principal Investigator: Deborah Levine, MD | |
| Methodist Healthcare System of San Antonio | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Gloria Carreon 210-575-3064 Gloria.Carreon@MHShealth.com | |
| Principal Investigator: Michael Kwan, MD | |
| United States, Virginia | |
| Inova Fairfax Hospital | Recruiting |
| Falls Church, Virginia, United States, 22042 | |
| Contact: Mary Smith 703-776-7128 marya.smith@inova.org | |
| Principal Investigator: Oksana Shlobin, MD | |
| Sentara Cardiovascular Research Institute | Recruiting |
| Norfolk, Virginia, United States, 23507 | |
| Contact: Melinda Bullivant, RN, MSN 757-388-4024 MMBULLIV@sentara.com | |
| Principal Investigator: Michael Eggert, MD | |
| United States, Wisconsin | |
| Aurora Health Care | Recruiting |
| Milwaukee, Wisconsin, United States, 53215 | |
| Contact: Valerie Zindars, RN 414-649-6853 valerie.zindars@aurora.org | |
| Principal Investigator: Dianne Zwicke, MD | |
Sponsors and Collaborators
United Therapeutics
More Information
No publications provided
| Responsible Party: | United Therapeutics |
| ClinicalTrials.gov Identifier: | NCT01266265 History of Changes |
| Other Study ID Numbers: | RIN-PH-403 |
| Study First Received: | December 22, 2010 |
| Last Updated: | October 5, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by United Therapeutics:
|
pulmonary arterial hypertension PAH treprostinil sodium Tyvaso inhalation Ventavis iloprost prostacyclin epoprostenol sodium Flolan subcutaneous and intravenous prostacyclin analogue |
Remodulin oral ERA bosentan Tracleer ambrisentan Letairis oral PDE5 inhibitors sildenafil Revatio tadalafil Adcirca |
Additional relevant MeSH terms:
|
Hypertension, Pulmonary Hypertension Lung Diseases Respiratory Tract Diseases Vascular Diseases Cardiovascular Diseases Epoprostenol Iloprost Treprostinil Bosentan Tezosentan Sildenafil |
Tadalafil Phosphodiesterase 5 Inhibitors Platelet Aggregation Inhibitors Hematologic Agents Therapeutic Uses Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Vasodilator Agents Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013