Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH Therapies
Overview[ - collapse ][ - ]
| Purpose | A surveillance of respiratory tract related adverse events in patients treated with Tyvaso®(treprostinil) Inhalation Solution versus other FDA approved therapies |
|---|---|
| Condition | Pulmonary Arterial Hypertension |
| Intervention | Drug: inhaled prostacyclin Drug: inhaled prostacyclin Drug: prostacyclin Drug: subcutaneous and intravenous prostacyclin Drug: oral ERA Drug: oral PDE5 inhibitors |
| Phase | N/A |
| Sponsor | United Therapeutics |
| Responsible Party | United Therapeutics |
| ClinicalTrials.gov Identifier | NCT01266265 |
| First Received | December 22, 2010 |
| Last Updated | February 28, 2014 |
| Last verified | February 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | December 22, 2010 |
|---|---|
| Last Updated Date | February 28, 2014 |
| Start Date | December 2010 |
| Estimated Primary Completion Date | December 2014 |
| Current 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] |
| Current 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] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH Therapies |
|---|---|
| Official Title | A Postmarketing Observational Study to Assess Respiratory Tract Adverse Events in Pulmonary Arterial Hypertension Patients Treated With Tyvaso® (Treprostinil) Inhalation Solution |
| Brief Summary | A surveillance of respiratory tract related adverse events in patients treated with Tyvaso®(treprostinil) Inhalation Solution versus other FDA approved therapies |
| 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. |
| Study Type | Observational |
| Study Phase | N/A |
| Study Design | Observational Model: Cohort, Time Perspective: Prospective |
| Condition | Pulmonary Arterial Hypertension |
| Intervention | Drug: inhaled prostacyclin Tyvaso Other Names: treprostinilDrug: inhaled prostacyclin As prescribed by the physician Other Names: iloprost, VentavisDrug: prostacyclin As prescribed by the physician Other Names: epoprostenol sodium, FlolanDrug: subcutaneous and intravenous prostacyclin As prescribed by physician Other Names: treprostinil , RemodulinDrug: oral ERA As prescribed by physician Other Names:
As prescribed by physician Other Names:
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| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 1320 |
| Estimated Completion Date | December 2014 |
| Estimated Primary Completion Date | July 2014 |
| Eligibility 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 |
| Gender | Both |
| Ages | 1 Year |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Nicole H Leedom 919-425-5870 nleedom@unither.com |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01266265 |
|---|---|
| Other Study ID Numbers | RIN-PH-403 |
| Has Data Monitoring Committee | No |
| Information Provided By | United Therapeutics |
| Study Sponsor | United Therapeutics |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | February 2014 |
Locations[ + expand ][ + ]
| Cardiovascular Associates, P.C. | Birmingham, Alabama, United States, 35213 Contact: Suzanne Frew, RN | 205-599-6385 | sfrew@cvapc.comPrincipal Investigator: Barry Rayburn, MD Recruiting |
|---|---|
| The University of Alabama at Birmingham | Birmingham, Alabama, United States, 35294 Contact: Leigh Powell, MSN, BSN, RN, CCRC | 205-975-9859 | leigh83@uab.eduPrincipal Investigator: Robert C. Bourge, MD Recruiting |
| University of South Alabama | Mobile, Alabama, United States, 36693 Contact: Jennifer Smith | 251-471-7291 | jksmith@usouthal.eduPrincipal Investigator: Karen Fagan, MD Recruiting |
| Arizona Pulmonary Specialists, LTD | Phoenix, Arizona, United States, 85013 Completed |
| Berkeley Cardiovascular Medical Group | Berkeley, California, United States, 94705 Contact: Eileen Healy, NP | 510-204-1691 | healye@bcvmg.comPrincipal Investigator: Luisa Munoz, MD Recruiting |
| Cedars-Sinai Heart Institute | Beverly Hills, California, United States, 90211 Contact: Lucilla Garcia | 310-248-7134 | Lucilla.Garcia@cshs.orgPrincipal Investigator: Antoine Hage, MD Recruiting |
| University California San Francisco | Fresno, California, United States, 93721 Contact: Sonja Garcia | 559-459-4042 | SGarcia@fresno.ucsf.eduPrincipal Investigator: Vijay Balasubramanian, MD Recruiting |
| University of Southern California | Los Angeles, California, United States, 90033 Contact: Lynn Fukushima | 323-442-9580 | Lynn.Fukushima@med.usc.eduPrincipal Investigator: Sivagini Ganesh, MD Recruiting |
| West Los Angeles VA Healthcare Center | Los Angeles, California, United States, 90073 Contact: Wendy Hill | 310-268-4314 | Wendy.Hill@va.govPrincipal Investigator: Shelly Shapiro, MD Recruiting |
| University of California Davis Medical Center | Sacramento, California, United States, 95817 Contact: Kirsten Alman | 916-734-5581 | kirsten.alman@ucdmc.ucdavis.eduPrincipal Investigator: Roblee P. Allen, MD Recruiting |
| University of California, San Francisco | San Francisco, California, United States, 94143 Contact: Leslie Ziani | 415-476-4014 | lziani@medicine.ucsf.eduPrincipal Investigator: Teresa DeMarco, MD Recruiting |
| Paloma Medical Group | San Juan Capistrano, California, United States, 92675 Contact: Theresa Schwarz, RN | 949-443-4114 | rn1232@hotmail.comPrincipal Investigator: Michael Rovzar, MD Recruiting |
| Santa Barbara Cottage Hospital | Santa Barbara, California, United States, 93105 Contact: Zorina Schultz | 805-569-7461 | zschultz@sbch.orgPrincipal Investigator: Jeffery Sager, MD Recruiting |
| Stanford Hospital and Clinics | Stanford, California, United States, 94305 Contact: Patricia Del Rosario | 650-721-2408 | pdelrosa@stanford.eduPrincipal Investigator: Roham Zamanian, MD Recruiting |
| Children's Hospital Denver | Denver, Colorado, United States, 80045 Contact: Kathleen Miller-Reed, RN | 720-777-6427 | Miller-Reed.Kathleen@tchden.orgPrincipal Investigator: D. Dunbar Ivy, MD Recruiting |
| Western States Clinical Research, Inc. | Wheat Ridge, Colorado, United States, 80033 Contact: Cheri Casey | 303-940-9773 | cheri@wscrinc.comPrincipal Investigator: Robert Benkert, MD Recruiting |
| St. Francis Sleep Allergy & Lung | Clearwater, Florida, United States, 33765 Contact: Ann Gove | 727-447-3000222 | agove@stfrancismed.comPrincipal Investigator: Frank Averill, MD Recruiting |
| University of Florida | Gainesville, Florida, United States, 32610 Contact: Christina Eagan | 352-273-8990 | Christina.Eagan@medicine.ufl.eduPrincipal Investigator: Hassan Alnuaimat, MD Recruiting |
| University of Florida College of Medicine Jacksonville | Jacksonville, Florida, United States, 32209 Contact: Minal Patel | 904-244-1106 | Minal.Patel@jax.ufl.eduPrincipal Investigator: Abubakr Bawja, MD Recruiting |
| Mayo Clinic Jacksonville | Jacksonville, Florida, United States, 32224 Contact: Shannon Kennedy | 904-953-7439 | kennedy.shannon@mayo.eduPrincipal Investigator: Charles Burger, MD Recruiting |
| Pulmonary and Critical Care Associates | Jacksonville, Florida, United States, 32204 Contact: Ronni Wetmore | 904-366-3738 | rwetmore@paccaweb.comPrincipal Investigator: Mitchell Rothstein, MD Recruiting |
| Miami Center for Cardiovascular Disease | Miami, Florida, United States, 33136 Contact: Tisha Diaz | 786-250-9399 | tishad@smiamiheart.comPrincipal Investigator: Javier Jimenez, MD Recruiting |
| Mount Sinai Medical Center | Miami Beach, Florida, United States, 33140 Contact: Helen Garcia | 305-674-2162 | helen.garcia@msmc.comPrincipal Investigator: Esteban Escolar, MD Recruiting |
| Central Florida Pulmonary Group, P.A. | Orlando, Florida, United States, 32806 Contact: Linda Tilme | ltilme@gcrm.comPrincipal Investigator: Daniel Layish, MD Recruiting |
| Orlando Heart Center | Orlando, Florida, United States, 32806 Contact: Sally Hewit | 407-650-1348 | SHewit@orlandoheart.comPrincipal Investigator: James Tarver, III, MD Recruiting |
| Cleveland Clinic Florida | Weston, Florida, United States, 33331 Contact: Norma Jean Barton | bartonn2@ccf.orgPrincipal Investigator: Franck F Rahaghi, MD Recruiting |
| Emory University School of Medicine | Atlanta, Georgia, United States, 30322 Contact: Jane Gillespie | 404-712-8204 | jegille@emory.eduPrincipal Investigator: Micah Fisher, MD Recruiting |
| Georgia Lung Associates, PC | Austell, Georgia, United States, 30106 Contact: Stacy Beasley | 770-745-14044 | sbeasley_gcr@yahoo.comPrincipal Investigator: Chad Miller, MD Recruiting |
| Northwestern Medical Center | Chicago, Illinois, United States, 60611 Contact: Clare Marlin | 312-695-2269 | clare-murphy@northwestern.eduPrincipal Investigator: Michael Cuttica, MD Recruiting |
| University of Illinois at Chicago | Chicago, Illinois, United States, 60612 Contact: Yvonne Valencia | 312-996-9191 | yvalenc2@uic.eduPrincipal Investigator: Roberto Machado, MD Recruiting |
| Rush University Medical Center | Chicago, Illinois, United States, 60612 Contact: Joyce Brown | 312-942-6771 | Joyce_Brown@rush.eduPrincipal Investigator: Rajive Tandon, MD Recruiting |
| Midwest Heart Foundation | Oakbrook Terrace, Illinois, United States, 60181 Contact: Alicja (Alice) Szydlowska | 630-255-2348 | alicja.szydlowska@advocatehealth.comPrincipal Investigator: Maria Rosa Costanzo, MD Recruiting |
| Indiana University Hospital | Carmel, Indiana, United States, 46032 Contact: Betty Logan, MD | 317-688-3846 | blogan@iuhealth.orgPrincipal Investigator: William Harvey, MD Recruiting |
| University of Iowa | Iowa City, Iowa, United States, 52242 Contact: Cynthia Larew | 319-353-7953 | cynthia-larew@uiowa.eduPrincipal Investigator: Sif Hansdottir, MD Recruiting |
| Mercy Hospital | Iowa City, Iowa, United States, 52245 Contact: Amy Becker, RN | 319-688-7026 | Amy.Becker@mercyic.orgPrincipal Investigator: Vikas Sharotri, MD Recruiting |
| University of Kansas Medical Center | Kansas City, Kansas, United States, 66160 Contact: Marla Watson | 913-588-4022 | mwatson5@kumc.eduPrincipal Investigator: Leslie Spikes, MD Recruiting |
| Kentuckiana Pulmonary Associates | Louisville, Kentucky, United States, 40202 Contact: Kim Hobbs | 502-587-8000 | khobbs@kpadocs.comPrincipal Investigator: Wes John McConnell, MD Recruiting |
| Johns Hopkins University | Baltimore, Maryland, United States, 21205 Contact: Zeling Cao | 410-614-2006 | Zcao5@jhmi.eduPrincipal Investigator: Stephen Mathai, MD Recruiting |
| University of Maryland | Baltimore, Maryland, United States, 21201 Contact: Faith Pa'ahana-Brown | 410-328-4433 | fpaahana@medicine.umaryland.eduPrincipal Investigator: Myung Park, MD Recruiting |
| Tufts - New England Medical Center | Boston, Massachusetts, United States, 02111 Contact: Karen Visnaw, RN | 617-636-1334 | kvisnaw@tuftsmedicalcenter.orgPrincipal Investigator: Nicholas Hill, MD Recruiting |
| Brigham and Women's Hospital | Boston, Massachusetts, United States, 02115 Contact: Laurie Lawler, RN | 617-525-9731 | LLAWLER@PARTNERS.ORGPrincipal Investigator: Aaron Waxman, MD Recruiting |
| Henry Ford Health System | Detroit, Michigan, United States, 48202 Contact: Beverly Stallings | 313-916-1254 | bstalli1@hfhs.orgPrincipal Investigator: Hector Cajigas, MD Recruiting |
| William Beaumont Hospital | Troy, Michigan, United States, 48085 Contact: Coleen Tessmar | 248-964-8524 | ctessmar@beaumont.eduPrincipal Investigator: Samuel Allen, MD Recruiting |
| Mayo Clinic | Rochester, Minnesota, United States, 55905 Contact: Annette McNallan | 507-266-3639 | mcnallan.annette@mayo.eduPrincipal Investigator: Robert Frantz, MD Recruiting |
| Nebraska Pulmonary Specialties, LLC | Lincoln, Nebraska, United States, 68506 Contact: Lisa Whisenhunt | 402-483-8684 | lisaw@npsllc.orgPrincipal Investigator: Jeffrey Jarrett, MD Recruiting |
| Hackensack University Medical Center | Hackensack, New Jersey, United States, 07601 Contact: Diane Agar | DAgar@HackensackUMC.orgPrincipal Investigator: Robert Berkowitz, MD Recruiting |
| UMDNJ - Robert Wood Johnson Medical Center Clinical Research Center | New Brunswick, New Jersey, United States, 08903 Contact: Deborah McCloskey | mcclosda@umdnj.eduPrincipal Investigator: Vivien Hsu, MD Recruiting |
| Newark Beth Israel Medical Center | Newark, New Jersey, United States, 07112 Contact: Juliet Williams | 973-926-8578 | JuWilliams@SBHCS.comPrincipal Investigator: Christina Migliore, MD Recruiting |
| SUNY Stony Brook University Medical Center | Islandia, New York, United States, 11790 Contact: Jacqueline Skarre | jacqueline.skarre@stonybrook.eduPrincipal Investigator: Paul Strachan, MD Recruiting |
| Winthrop Pulmonary Associates | Mineola, New York, United States, 11501 Contact: Kim Byrnes, LPN | kbyrnes@winthrop.orgPrincipal Investigator: Shilpa Ann DeSouza, MD Recruiting |
| North Shore - Long Island Jewish Health System | New Hyde Park, New York, United States, 11040 Contact: Sameer Verma | 516-465-5437 | sverma3@nshs.eduPrincipal Investigator: Arunabh Talwar, MD Recruiting |
| Columbia University Medical Center | New York, New York, United States, 10032 Contact: Jane Devereux | 212-305-4436 | jhd2123@Columbia.eduPrincipal Investigator: Erika Berman-Rosenzweig, MD Recruiting |
| St. Luke's-Roosevelt Hospital Center | New York, New York, United States, 10019 Contact: Lori Tartell | 212-523-5471 | LTARTELL@CHPNET.ORGPrincipal Investigator: Ruth Minkin, MD Recruiting |
| Mary M Parkes Center | Rochester, New York, United States, 14623 Contact: Chris Weaver | 585-273-4351123 | Christine_Weaver@URMC.Rochester.eduPrincipal Investigator: R. James White, MD Recruiting |
| Pulmonary Health Physicians | Syracuse, New York, United States, 13210 Contact: Cathy Fogus | 315-234-0816 | cathy.fogus@cnylungs.comPrincipal Investigator: Sherif El Bayadi, MD Recruiting |
| University of North Carolina at Chapel Hill | Chapel Hill, North Carolina, United States, 27599 Contact: Sarah McGee | 919-966-2531 | smcgee@med.unc.eduPrincipal Investigator: Hubert Ford, MD Recruiting |
| Pinehurst Medical Clinic | Pinehurst, North Carolina, United States, 28374 Contact: Joann McSorley | 910-235-3144 | jmcsorley@pinehurstmedical.comPrincipal Investigator: Michael Pritchett, MD Recruiting |
| Wake Forest University Health Sciences | Winston-Salem, North Carolina, United States, 27157 Contact: Gayle Marterre | 336-716-0573 | gmarterr@wakehealth.eduPrincipal Investigator: Rodolfo Pascual, MD Recruiting |
| Akron General Hospital | Akron, Ohio, United States, 44302 Contact: Debbie Hudock | 330-344-1570 | dhudock@agmc.orgPrincipal Investigator: Michael Passero, MD Recruiting |
| University of Cincinnati | Cincinnati, Ohio, United States, 45267-0564 Contact: Stephanie Hartke | 513-558-2148 | stephanie.hartke@uc.eduPrincipal Investigator: Jean Elwing, MD Recruiting |
| University Hospitals of Cleveland | Cleveland, Ohio, United States, 44106 Contact: David Haney | 216-844-2381 | david.haney@uhhospitals.orgPrincipal Investigator: Robert Schliz, MD Recruiting |
| Davis Heart and Lung Research Institute | Columbus, Ohio, United States, 43210 Contact: Rebecca Anderson | 614-247-7793 | RebeccaG.Anderson@osumc.eduPrincipal Investigator: Veronica Franco, MD Recruiting |
| Mercy Fairfield Hospital | Fairfield, Ohio, United States, 45014 Contact: MaryLou Sauer | 513-603-8236 | smdsauer@yahoo.comPrincipal Investigator: Lynne Wagoner, MD Recruiting |
| OHSU-Oregon Health and Science University | Portland, Oregon, United States, 97239 Contact: Nathan Kessler | 503-494-9570 | kesslena@ohsu.eduPrincipal Investigator: Akram Khan, MD Recruiting |
| Legacy Pulmonary Northwest | Portland, Oregon, United States, 97210 Contact: Tamara Mayfield | 503-413-7945 | TMayfiel@LHS.ORGPrincipal Investigator: Catherine Markin, MD Recruiting |
| Oregon Clinic, PC | Portland, Oregon, United States, 97220 Contact: Meg Day | 503-963-3182 | mday@orclinic.comPrincipal Investigator: Rhett Cummings, MD Recruiting |
| Penn State Milton S. Hershey Medical Center | Hershey, Pennsylvania, United States, 17033 Contact: Robert Vender, MD | rvender@hmc.psu.eduPrincipal Investigator: Robert Vender, MD Recruiting |
| Thomas Jefferson University | Philadelphia, Pennsylvania, United States, 19107 Contact: Paul Park | 215-503-4070 | paul.park@jefferson.eduPrincipal Investigator: Michael Scharf, MD Recruiting |
| Children's Hospital of Philadelphia | Philadelphia, Pennsylvania, United States, 19104 Contact: Kevin Gralewski | 267-426-3159 | gralewskik@email.chop.eduPrincipal Investigator: Brian Hanna, MD Recruiting |
| Temple University | Philadelphia, Pennsylvania, United States, 19140 Contact: Melody Santiago | Melody.Santiago@tuhs.temple.eduPrincipal Investigator: Shelia Weaver, MD Recruiting |
| University of Pennsylvania Health System | Philadelphia, Pennsylvania, United States, 19104 Contact: Christine Malloy | 215-513-2999 | christine.malloy@uphs.upenn.eduPrincipal Investigator: Eduardo Rame, MD Recruiting |
| Allegheny General Hospital | Pittsburgh, Pennsylvania, United States, 15212 Contact: Lauren Machen | 412-359-6181 | lmachen@wpahs.orgPrincipal Investigator: Raymond Benza, MD Recruiting |
| University of Pittsburgh Medical Center | Pittsburgh, Pennsylvania, United States, 15213-2582 Contact: Mary Pollera | 412-647-2820 | pollerame@upmc.eduPrincipal Investigator: Michael Mathier, MD Recruiting |
| Berks Schuylkill Respiratory Specialists, Ltd. | Wyomissing, Pennsylvania, United States, 19610 Contact: Lisa Hill | 610-685-5864166 | lhill@lungmd.netPrincipal Investigator: Alec Platt, MD Recruiting |
| Rhode Island Hospital | Providence, Rhode Island, United States, 02903 Contact: Barbara Smithson | 401-444-9097 | BSmithson@Lifespan.orgPrincipal Investigator: James Klinger, MD Recruiting |
| Lexington Pulmonary and Critical Care | Lexington, South Carolina, United States, 29072 Completed |
| MD Total Care, PLLC | Chattanooga, Tennessee, United States, 37419 Completed |
| Summit Medical Group | Knoxville, Tennessee, United States, 37909 Contact: Monica Goins | 423-989-3105 | mgoins@pmg-research.comPrincipal Investigator: John Swisher, MD Recruiting |
| Vanderbilt University Medical Center | Nashville, Tennessee, United States, 37232 Contact: Shelly Gonzalez | 615-343-8277 | rochelle.gonzalez@Vanderbilt.EduPrincipal Investigator: Ivan Robbins, MD Recruiting |
| UT Southwestern Medical Center | Dallas, Texas, United States, 75390 Contact: Yvonne Pena | 214-645-7148 | Yvonne.Pena@UTSouthwestern.eduPrincipal Investigator: Sonja Bartolome, MD Recruiting |
| Texas Children's Hospital | Houston, Texas, United States, 77030 Contact: Charles Sellers | 832-822-4790 | cxseller@texaschildrens.orgPrincipal Investigator: Fadel Ruiz, MD Recruiting |
| University of Texas Health Science Center at Houston | Houston, Texas, United States, 77030 Contact: Kristi Baysinger | 713-500-6851 | Kristi.L.Baysinger@uth.tmc.eduPrincipal Investigator: Bela Patel, MD Recruiting |
| Baylor College of Medicine | Houston, Texas, United States, 77030 Contact: Jennifer L Lee | 713-798-2400 | jllee@bcm.eduPrincipal Investigator: Zeenat Safdar, MD Recruiting |
| University of Texas Health Science Center at San Antonio | San Antonio, Texas, United States, 78229 Contact: Regina Whitener, RN | 210-617-530014549 | WHITENER@uthscsa.eduPrincipal Investigator: Deborah Levine, MD Recruiting |
| Methodist Healthcare System of San Antonio | San Antonio, Texas, United States, 78229 Contact: Gloria Carreon | 210-575-3064 | Gloria.Carreon@MHShealth.comPrincipal Investigator: Michael Kwan, MD Recruiting |
| Inova Fairfax Hospital | Falls Church, Virginia, United States, 22042 Contact: Mary Smith | 703-776-7128 | marya.smith@inova.orgPrincipal Investigator: Oksana Shlobin, MD Recruiting |
| Sentara Cardiovascular Research Institute | Norfolk, Virginia, United States, 23507 Contact: Melinda Bullivant, RN, MSN | 757-388-4024 | MMBULLIV@sentara.comPrincipal Investigator: Michael Eggert, MD Recruiting |
| Aurora Health Care | Milwaukee, Wisconsin, United States, 53215 Contact: Valerie Zindars, RN | 414-649-6853 | valerie.zindars@aurora.orgPrincipal Investigator: Dianne Zwicke, MD Recruiting |