SYMPHONY: A Study of Macitentan in Pulmonary Arterial Hypertension to Validate the PAH-SYMPACT

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Actelion
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01841762
First received: March 27, 2013
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

SYMPHONY is prospective, multi-center, open-label, single-arm, Phase 3b psychometric validation study of the PAH-SYMPACT, a new quality of life questionnaire for patients with pulmonary arterial hypertension. Patients will be in the study for 5 1/2 months, 4 months of which they will receive macitentan, 10 mg, once daily.

The primary objectives are to demonstrate the final content validity of the PAH SYMPACT instrument, to demonstrate the psychometric characteristics of reliability and construct validity of the PAH-SYMPACT instrument, and to demonstrate the ability of the PAH SYMPACT instrument to detect change. The secondary objective is to assess the safety of macitentan in patients with pulmonary arterial hypertension. The exploratory objective is to explore the effects of macitentan on PAH symptoms and their impact (as measured by the PAH-SYMPACT) in patients with pulmonary arterial hypertension.


Condition Intervention Phase
Pulmonary Arterial Hypertension
Drug: Macitentan
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • Development of patient-reported outcome measure of symptoms and their impact in PAH (the PAH-SYMPACT) [ Time Frame: From Screening Visit (Visit 1) to End of Treatment (EOT) Visit (Visit 4, Week 16) ] [ Designated as safety issue: No ]
    Assessed through item analyses, factor analyses, and Rasch analyses.


Secondary Outcome Measures:
  • To assess the frequency of treatment-emergent adverse events, serious adverse events, and adverse events leading to study drug discontinuation from Baseline to Week 16. [ Time Frame: From Baseline Visit (Visit 2, Day 1) to End of Treatment (EOT) Visit (Visit 4, Week 16) ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Change from Baseline to Week 16 in the symptom and impact scales of the PAH-SYMPACT. [ Time Frame: From Baseline Visit (Visit 2, Day 1) to End of Treatment (EOT) Visit (Visit 4, Week 16) ] [ Designated as safety issue: No ]
    Assessed by the PAH-SYMPACT questionnaire.


Estimated Enrollment: 275
Study Start Date: April 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Macitentan
Macitentan tablet, dose of 10 mg, once daily
Drug: Macitentan
Macitentan tablet, dose of 10 mg, once daily
Other Name: Macitentan / ACT-064992

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent prior to initiation of any study mandated procedure
  2. Patients with symptomatic PAH in World Health Organization (WHO) Functional Class (FC) II to IV
  3. Patients with PAH belonging to one of the following subgroups of the Dana Point Clinical Classification Group 1:

    1. Idiopathic, or
    2. Heritable, or
    3. Drug or toxin induced, or
    4. Associated with one of the following:

    i. Connective tissue disease ii. Congenital heart disease with simple systemic-to-pulmonary shunt at least one year after surgical repair iii. HIV infection

  4. Documented hemodynamic diagnosis of PAH by right heart catheterization - performed at any time prior to Screening showing:

    1. Resting mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg and
    2. Resting pulmonary vascular resistance (PVR) > 240 dyn•s•cm-5 and
    3. Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) ≤ 15 mmHg
  5. 6-minute walk distance (6MWD) ≥ 150 m at Screening
  6. Able to fluently speak and read English
  7. For patients on phosphodiesterase type-5 inhibitors (PDE5i), inhaled prostacyclin analogues, or calcium channel blockers, stable doses for at least 3 months prior to Visit 2
  8. For patients on oral diuretics, stable doses for at least 4 weeks prior to Visit 2
  9. Men or women aged 18 or older

    1. A woman is considered to be of childbearing potential unless she:

      • Has not yet entered puberty, or
      • Does not have a uterus, or
      • Has gone through menopause (has not had a period for at least 12 months for natural reasons, or who has had their ovaries removed)
    2. A women of childbearing potential is eligible only if she meets both criteria below:

      • Has a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline and agree to perform monthly urine pregnancy tests, and
      • Agrees to use two methods of contraception (one method for patients with a progesterone implant or an intrauterine device or tubal sterilization) from the Screening Visit 1 until one month after study drug discontinuation

Exclusion Criteria:

  1. Moderate to severe obstructive lung disease: forced expiratory volume in one second (FEV1) / forced vital capacity < 70% and FEV1 < 65% of predicted value after bronchodilator administration
  2. Moderate to severe restrictive lung disease: total lung capacity < 60% of predicted value
  3. Hemoglobin < 75% of the lower limit of the normal range at screening
  4. Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 times the upper limit of normal (ULN) at screening
  5. Estimated creatinine clearance < 30 mL/min at screening
  6. Systolic blood pressure (SBP) < 90 mmHg at screening
  7. Body weight < 40 kg at screening
  8. Known concomitant life-threatening diseases with a life expectancy of < 12 months
  9. Any condition that prevents compliance with the protocol or adherence to therapy
  10. Treatment with endothelin receptor antagonists (ERAs) within 3 months prior to Visit 2, or scheduled to receive any of these compounds, other than macitentan, during the trial
  11. Treatment with intravenous or subcutaneous prostacyclin or prostacyclin analogs within 3 months prior to Visit 2, or scheduled to receive any of these compounds during the trial
  12. Treatment with riociguat within 3 months prior to Visit 2, or scheduled to receive riociguat during the trial
  13. Treatment with strong cytochrome P450 (CYP) 3A4 inducers or inhibitors within 4 weeks prior to Visit 2
  14. Recently started (< 8 weeks prior to Visit 2) or planned cardio-pulmonary rehabilitation program based on exercise
  15. Females who are lactating or pregnant (positive Screening or Baseline pregnancy test) or plan to become pregnant during the study
  16. Known hypersensitivity to macitentan or its excipients or drugs of the same class
  17. Treatment with another investigational drug within 3 months prior to Visit 2
  18. Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease
  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: NCT01841762

Contacts
Contact: Scott Tsurutani 650 808 - 6586 scott.tsurutani@actelion.com

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Jose Tallaj    205-934-3624    jtallaj@uab.edu   
Contact: Gregory Wright    (205) 934-8767    gwright@uab.edu   
Principal Investigator: Jose Tallaj, MD         
Cardiovascular Associates of the Southeast, LLC Recruiting
Birmingham, Alabama, United States, 35243
Contact: Barry Rayburn    205-599-6374    brayburn@cvapc.com   
Contact: Vontrina Jones    205-599-6374    vojones@cvapc.com   
Principal Investigator: Barry Rayburn, MD         
United States, Arizona
Mayo Clinic Arizona Recruiting
Phoenix, Arizona, United States, 85054-4502
Contact: Robert L Scott    480-342-2376    scott.robert@mayo.edu   
Contact: Arcenio Galindo    (480) 342-3987    galindo.arcenio@mayo.edu   
Principal Investigator: Robert L Scott, MD         
Pulmonary Associates, PA Recruiting
Phoenix, Arizona, United States, 85006-2611
Contact: David M Baratz    602-258-4951    dbaratz@aol.com   
Contact: LiYi Fu    (602) 346-4743    palyf@aol.com   
Principal Investigator: David M Baratz, MD         
United States, California
Cedars-Sinai Medical Center Recruiting
Beverly Hills, California, United States, 90211
Contact: Antoine Hage    310-248-8300    hagea@cshs.org   
Contact: Lucy Garcia    (310) 248-7134    lucilla.garcia@cshs.org   
Principal Investigator: Antoine Hage, MD         
UCSF Fresno Recruiting
Fresno, California, United States, 93701
Contact: Vijay Balasubramanian    559-499-6637    vbalasubramanian@fresno.ucsf.edu   
Contact: Sonia Garcia    (559) 499-6637    SGarcia@fresno.ucsf.edu   
Principal Investigator: Vijay Balasubramanian, MD         
UCSD Medical Center, Pulmonary Department Recruiting
La Jolla, California, United States, 92093
Contact: David Poch    858-657-7150      
Contact: Melissa Thrasher    (858) 657-7127    mthrasher@ucsd.edu   
Principal Investigator: David Poch, MD         
University of California Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Rajan Saggar    310-267-7492    rsaggar@mednet.ucla.edu   
Contact: Lynne Yoder    (310) 206-4112    lyoder@mednet.ucla.edu   
Principal Investigator: Rajan Saggar, MD         
VAGLAHS, VA Greater LA Healthcare System Recruiting
Los Angeles, California, United States, 90073
Contact: Shelley Shapiro    310-268-4314    Shelley.shapiro@va.gov   
Contact: Wendy Hill    (310) 268-4314    wendy.hill@va.gov   
Principal Investigator: Shelley Shaprio, MD         
University of California San Francisco Medical Center Recruiting
San Francisco, California, United States, 94143
Contact: Munir Janmohamed       Munir.Janmohamed@ucsf.edu   
Principal Investigator: Munir Janmohamed, MD         
Stanford University Recruiting
Stanford, California, United States, 94305-2200
Contact: Roham Zamanian    650-725-5495    zamanian@stanford.edu   
Contact: Val Scott    (650) 725-9861    valscott@stanford.edu   
Principal Investigator: Roham Zamanian, MD         
Los Angeles Biomedical Research Institute Recruiting
Torrance, California, United States, 90502
Contact: Ronald Oudiz    310-222-2515    roudiz@labiomed.org   
Contact: Joy Beckmann    (310) 222-3560    jbeckmann@labiomed.org   
Principal Investigator: Ronald Oudiz, MD         
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: David Badesch    720-848-6518    david.badesch@ucdenver.edu   
Contact: Brenda Kuiphoff    (720) 848-6541    brenda.kuiphoff@ucdenver.edu   
Principal Investigator: David Badesch, MD         
United States, District of Columbia
Medstar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: George Ruiz    202-877-8085    george.ruiz@medstar.net   
Contact: Margaret Kildee    (202) 877-0613    margaret.m.kildee@medstar.net   
Principal Investigator: George Ruiz, MD         
MedStar Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Contact: Tunay Kuru    202-444-8830    tk53@gunet.georgetown.edu   
Contact: Rachelle Campbell    202-444-4982    rc82@gunet.georgetown.edu   
Principal Investigator: Tunay Kuru, MD         
United States, Florida
Bay Area Cardiology Associates, P.A. Recruiting
Brandon, Florida, United States, 33511
Contact: Robert Dewhurst    813-684-6000    rdewhurs@yahoo.com; bac.research@bayareacardiology.com   
Contact: Trudy Foster    (813) 684-6000 x264    bac.research@bayareacardiology.com   
Principal Investigator: Robert Dewhurst, MD         
University of Florida Academic Health Center Recruiting
Gainesville, Florida, United States, 32610
Contact: Hassan Alnuaimat    352-273-8737    hassan.alnuaimat@medicine.ufl.edu   
Contact: Christina Eagan    (352) 273-8990    eagancm@medicine.ufl.edu   
Principal Investigator: Hassan Alnuaimat, MD         
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224-1865
Contact: Charles Burger    904-953-2000    burger.charles@mayo.edu   
Contact: Shannon Kennedy    (904) 953-8557    Kennedy.shannon@mayo.edu   
Principal Investigator: Charles Burger, MD         
University of Florida College of Medicine, Jacksonville Recruiting
Jacksonville, Florida, United States, 32209
Contact: Abubakr Bajwa    904-244-1106    Abubakr.Bajwa@jax.ufl.edu   
Contact: Minal Patel    904-244-1106    Minal.Patel@jax.ufl.edu   
Principal Investigator: Abubakr Bajwa, MD         
Cleveland Clinic Florida Recruiting
Weston, Florida, United States, 33331-3609
Contact: Franck Rahaghi    954-659-5450    rahaghf@ccf.org   
Contact: Calvin Killingbeck    (954) 659-6247    killinc@ccf.org   
Principal Investigator: Franck Rahaghi, MD         
United States, Georgia
Georgia Regents University Recruiting
Augusta, Georgia, United States, 30912
Contact: James R Gossage    706-721-0470    jgossage@gru.edu   
Contact: Melissa James    (706) 721-8391    mejames@gru.edu   
Principal Investigator: James R Gossage, MD         
Georgia Clinical Research Recruiting
Austell, Georgia, United States, 30106
Contact: Chad Miller    770-745-1404 ext 2    cemiller74@gmail.com   
Contact: Kristen Burks    770-745-1404 ext 2    kburks_gcr@yahoo.com   
Principal Investigator: Chad Miller, MD         
United States, Illinois
University of Chicago Medical Recruiting
Chicago, Illinois, United States, 60637
Contact: Mardi Gomberg-Maitland    773-702-5589    mgomberg@medicine.bsd.uchicago.edu   
Contact: Cherylanne Glassner    (773) 834-5672    cglassne@bsd.uchicago.edu   
Principal Investigator: Mardi Gomberg-Maitland, MD         
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Michael Cuttica    312-695-4834    m-cuttica@northwestern.edu   
Contact: Clare Marlin    (312) 695-2269    clare-murphy@northwestern.edu   
Principal Investigator: Michael Cuttica, MD         
Advocate Health and Hospitals Corporation Recruiting
Oakbrook Terrace, Illinois, United States, 60181
Contact: Muhyaldeen Dia    708-636-7575    muhyaldeen@gmail.com   
Contact: Maureen Panella    (708) 636-7575    maureen.panella@advocatehealth.com   
Principal Investigator: Muhyaldeen Dia, MD         
United States, Iowa
Chest Infectious Diseases and Critical Care Associates, PC Recruiting
Des Moines, Iowa, United States, 50325-7046
Contact: Maxwell Cosmic    515-224-1777    maxcosmic@msn.com   
Contact: Mary Ann Smith    (515) 224-1777    MSmith@CICDOC.com   
Principal Investigator: Maxwell Cosmic, MD         
University of Iowa Hospitals & Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Linda Marie Cadaret    319-356-1616    linda-cardaret@uiowa.edu   
Contact: Page Scovel    (319)3848005    Scovelp@healthcare.uiowa.edu   
Principal Investigator: Linda Marie Cardaret, MD         
Iowa City Heart Center Recruiting
Iowa City, Iowa, United States, 52245
Contact: Vikas Sharotri    319-688-3883    dr.sharotri@iowacityheart.com   
Contact: Amy Becker    319-688-7026    amy.becker@mercyic.org   
Principal Investigator: Vikas Sharotri, MD         
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160-0001
Contact: Leslie Spikes    913-588-6045    LSpikes@kumc.edu   
Contact: Marla Watson    (913) 588-4022    Mwatson5@kumc.edu   
Principal Investigator: Leslie Spikes, MD         
Veritas Clinical Specialties Recruiting
Topeka, Kansas, United States, 66606
Contact: William Leeds    785-354-0735    Dr.leeds@psakansas.com   
Contact: Amy Lutz    (785) 354-0735    alutz@PSAKansas.com   
Principal Investigator: William Leeds, MD         
United States, Kentucky
Kentuckiana Pulmonary Associates Recruiting
Louisville, Kentucky, United States, 40202
Contact: Wesley McConnell    502-587-8000    mcco3526@bellsouth.net   
Contact: Kim Hobbs    502-587-8000 ext 125    khobbs@kpadocs.com   
Principal Investigator: Wesley McConnell, MD         
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Jimmy Smith    502-852-5841    jssmit23@louisville.edu   
Contact: Elizabeth McDaniel    (502) 852-5841      
Principal Investigator: Jimmy Smith, MD         
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Gautam Ramani    410-328-4394    gramani@medicine.umaryland.edu   
Contact: Lioubov Poliakova    (410) 328-6885    lpoliako@medicine.umaryland.edu   
Principal Investigator: Gautam Ramani, MD         
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Stephen Mathai    410-614-1648    smathai4@jhmi.edu   
Contact: Erica Pullins    (410) 614-1316    esmit110@jhmi.edu   
Principal Investigator: Stephen Mathai, MD         
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Nicholas Hill    617-636-4288    nhill@tuftsmedicalcenter.org   
Contact: Karen Visnaw    (617) 636-1334    kvisnaw@tuftsmedicalcenter.org   
Principal Investigator: Nicholas Hill, MD         
Boston University Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Harrison Farber    617-638-4860    hfarber@bu.edu   
Contact: Kimberly Finch    (617) 638-4475    kimtobin@bu.edu   
Principal Investigator: Harrison Farber, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109-5644
Contact: Vallerie McLaughlin    734-936-5383    vmclaugh@umich.edu; cvc-ph-research@med.umich.edu   
Contact: Aileen Patel    (734) 936-5383    cvc-ph-research@med.umich.edu   
Principal Investigator: Vallerie McLaughlin, MD         
Beaumont Hospital Recruiting
Troy, Michigan, United States, 48085
Contact: Samuel Allen    248-964-9719    sallen@beaumont.edu   
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: Robert Frantz    507-284-2511    koenig.luanne@mayo.edu   
Contact: LuAnne Koenig    (507) 284-4298    koenig.luanne@mayo.edu   
Principal Investigator: Robert Frantz, MD         
United States, Missouri
Midwest Pulmonary Consultants Recruiting
Kansas City, Missouri, United States, 64111
Contact: Mark Yagan    816-756-2255    myagan@saint-lukes.org   
Contact: Mindy Epstein    (816) 932-9892    mepstein@saint-lukes.org   
Principal Investigator: Mark Yagan, MD         
Clayton Sleep Institute Terminated
Saint Louis, Missouri, United States, 63143
Ferrell-Duncan Clinic Recruiting
Springfield, Missouri, United States, 65807
Contact: Stephen Roger Clum    417-875-3916    stephen.clum@coxhealth.com   
Contact: Melinda Smith    (417) 269-0598    melinda.smith@coxhealth.com   
Principal Investigator: Stephen Clum, MD         
Mercy Clinic Pulmonology Recruiting
St. Louis, Missouri, United States, 63141
Contact: George Matuschak    314-251-4966    george.matuschak@mercy.net   
Contact: Katie Krause    (314) 251-5653    krauca@mercy.net   
Principal Investigator: George Matuschak, MD         
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Murali Chakinala    314-454-8766    mchakina@dom.wustl.edu   
Contact: Ellen Newton-Lovato    (314) 454-8717    elovato@dom.wustl.edu   
Principal Investigator: Murali Chakinala, MD         
United States, Nebraska
Nebraska Pulmonary Specialties Recruiting
Lincoln, Nebraska, United States, 68506
Contact: William Michael Johnson    402-499-1030    billjlungs@hotmail.com   
Contact: Lisa Whisenhunt    402-483-8684    lisaw@npsllc.org   
Principal Investigator: William Michael Johnson, MD         
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Austin Thompson III    402-559-3777    athompso@unmc.edu   
Contact: Jane Lane    (402) 559-7555    Lanejt@unmc.edu   
Principal Investigator: Austin Thompson III, MD         
United States, New Jersey
Pulmonary and Critical Care Associates Recruiting
Union, New Jersey, United States, 07083
Contact: Ilia Segal    908-964-1964    dociliasegal@yahoo.com   
Contact: Tammy    908 964 1964    tl619@aol.com   
Principal Investigator: Ilia Segal, MD         
United States, New York
Montefiore Medical Center, Weiler Division Recruiting
Bronx, New York, United States, 10461
Contact: James Michael Tauras    718-920-5949    jtauras@montefiore.org   
Contact: Auris Browne    718-920-8576    aubrowne@montefiore.org   
Principal Investigator: James Michael Tauras, MD         
Buffalo General Medical Center Recruiting
Buffalo, New York, United States, 14203
Contact: William Gibbons    716-859-2271    wgibbons@kaleidahealth.org   
Contact: Rick Rejman    (716) 878-3320    rmrejman@buffalo.edu   
Principal Investigator: William Gibbons, MD         
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Shilpa Desouza    516-663-9582    sdesouza@winthrop.org; shilpaanne@yahoo.com   
Contact: Kimberly Byrnes    (516) 663-9582    kbyrnes@winthrop.org   
Principal Investigator: Shipla Desouza, MD         
North Shore-LIJ/Advance Lung Disease Clinic Recruiting
New Hyde Park, New York, United States, 11040
Contact: Arunabh Talwar    516-465-5416    arunabh@nshs.edu   
Contact: Sameer Verma    (516) 465-5437    SVerma3@NSHS.edu; vermasameermd@gmail.com   
Principal Investigator: Arunabh Talwar, MD         
Beth Israel Medical Center Recruiting
New York, New York, United States, 10003
Contact: Roxana Sulica    212-241-3913    rsulica@chpnet.org   
Contact: Rebecca Fenton    (212) 844-8263    rfenton@chpnet.org   
Principal Investigator: Roxana Sulica, MD         
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Erika Berman-Rosenzweig    212-305-4436    esb14@columbia.edu   
Contact: Candix Yanes    (212) 305-4436    cy2162@columbia.edu   
Principal Investigator: Erika Berman-Rosenzweig, MD         
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Hubert Ford    919-966-2531    hjford@med.unc.edu   
Contact: Sarah McGee    (919) 966-2531    smcgee@med.unc.edu   
Principal Investigator: Hubert Ford, MD         
Novant Health Pulmonary and Critical Care Recruiting
Matthews, North Carolina, United States, 28105
Contact: Carl Smart    704-264-1400    Casmart@novanthealth.org   
Contact: Christine Mackey    (704) 574-5157    cmackey@novanthealth.org   
Principal Investigator: Carl Smart, MD         
United States, Ohio
The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Peter Engel    859-572-7267    Lindnermd@thechristhospital.com   
Contact: Nancy Wagner       nancywagner@thechristhospital.com   
Principal Investigator: Peter Engel, MD         
UC Health/University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Jean M Elwing    513-558-4831    Jean.elwing@uc.edu   
Contact: Brandy Alexander    (513) 558-0027    Brandy.alexander@uc.edu   
Principal Investigator: Jean M Elwing, MD         
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 45219
Contact: Joseph Parambil    216-445-2610    parambj@ccf.org   
Contact: Kasi Timmerman    (216) 444-2140    TIMMERK@ccf.org   
Principal Investigator: Omar Minai, MD         
The Ohio State University Recruiting
Columbus, Ohio, United States, 43221
Contact: Namita Sood    614-293-4925    namita.sood@osumc.edu   
Contact: Stephen Deffenbaugh    (614) 293-3351    stephen.deffenbaugh@osumc.edu   
Principal Investigator: Namita Sood, MD         
Davis Heart & Lung Research Institute Recruiting
Columbus, Ohio, United States, 43210-1252
Contact: Curtis J Daniels    614-293-4967    curt.daniels@osumc.edu   
Contact: Michelle Bright    (614) 292-3496    Michelle.Bright@osumc.edu   
Principal Investigator: Curtis J Daniels, MD         
United States, Oklahoma
University of Oklahoma Health Sciences Center Terminated
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
CDA for Oregon Pulmonary Associate Recruiting
Portland, Oregon, United States, 97225
Contact: John A Butler    503-631-4491    jabutler@uic.edu   
Contact: Diane Snelson    503-631-4491    dianesegr@ccgmail.net   
Principal Investigator: John A Butler, MD         
The Oregon Clinic Recruiting
Portland, Oregon, United States, 97220
Contact: Wayne Strauss    503-963-3030    wstrauss@orclinic.com   
Contact: Arlena Loos    (503) 963-3183    aloos@orclinic.com   
Principal Investigator: Wayne Strauss, MD         
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Akram Khan    503-494-4493    khana@ohsu.edu   
Contact: Raeesa Khalid    (503) 494-9570    Khalid@ohsu.edu   
Principal Investigator: Akram Khan, MD         
United States, Pennsylvania
Temple Lung Center Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Albert Mamary    215-707-3332    albert.mamary@tuhs.temple.edu   
Contact: Gayle Jones    (215) 707-1041    gayle.jones@tuhs.temple.edu   
Principal Investigator: Albert Mamary, MD         
Thomas Jefferson University, Division on Pulmonary and Critical Care Recruiting
Philadelphia, Pennsylvania, United States, 19107-5109
Contact: Michael Scharf    215-955-6591    michael.scharf@jefferson.edu   
Contact: Lisa Pawlowski    (215) 955-2213    Lisa.pawlowski@jefferson.edu   
Principal Investigator: Michael Scharf, MD         
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212-4756
Contact: Amresh Raina    412-359-4760    araina@wpahs.org   
Contact: Joan Rossi    (412) 359-4760    jrossi1@wpahs.org   
Principal Investigator: Amresh Raina, MD         
UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15123
Contact: David Ishizawar    412-802-3131    ishizawardc@upmc.edu   
Contact: Mary Pollera    (412) 647-2820    Pollerame@upmc.edu   
Principal Investigator: David Ishizawar, MD         
Berks Schuylkill Respiratory Specialists, Ltd. Recruiting
Wyomissing, Pennsylvania, United States, 19610
Contact: Alec Platt    610-685-5864    alecplatt@gmail.com   
Contact: Lisa Hill    (610) 685-5864 ext 166    lhill@lungmd.net   
Principal Investigator: Alec Platt, MD         
Wellspan Lung, Sleep and Critical Care Recruiting
York, Pennsylvania, United States, 17402-8200
Contact: Dmitriy Zubkus    717-851-2465    dzubkus@wellspan.org   
Contact: Elizabeth Fisher    (717) 851-2465    efisher@wellspan.org   
Principal Investigator: Dmitriy Zubkus, MD         
United States, South Dakota
Sioux Falls Cardiovascular, PC Recruiting
Sioux Falls, South Dakota, United States, 57108
Contact: Kevin Vaska    605-274-6300    kjvaska@aol.com   
Contact: Nancy Nelson    (605) 274-6300    nnelson@siouxfallscardio.com   
Principal Investigator: Kevin Vaska, MD         
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390-8550
Contact: Kelly Chin    214-645-6486    Kelly.Chin@UTSouthwestern.edu   
Contact: Jacqueline Quivers    (214) 645-6489    jacqueline.quivers@utsouthwestern.edu   
Principal Investigator: Kelly Chin, MD         
Baylor Research Institute (BRI) Recruiting
Dallas, Texas, United States, 75204
Contact: Johannes Kuiper    214-820-2273    johannek@baylorhealth.edu   
Contact: Poupak Moshayedi       poupak.moshayedi@BaylorHealth.edu   
Principal Investigator: Johannes Kuiper, MD         
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030-2348
Contact: Zennat Safdar    713-798-2400    jllee@bcm.edu   
Contact: Jennifer L Lee    (713) 798-2400    jllee@bcm.edu   
Principal Investigator: Zeenat Safdar, MD         
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Bela Patel    713-500-6838    bela.patel@uth.tmc.edu   
Contact: Kristi Morin    (713) 500-6851    kristi.l.baysinger@uth.tmc.edu   
Principal Investigator: Bela Patel, MD         
Scott & White Memorial Hospital Recruiting
Temple, Texas, United States, 76508
Contact: Christopher Spradley    254-724-3227    cspradley@sw.org   
Contact: Lydia Clipper    (254) 724-6750    LCLIPPER@sw.org   
Principal Investigator: Christopher Spradley, MD         
United States, Virginia
Inova Heart and Vascular Institue / Inova Fairfax Hospital Recruiting
Falls Church, Virginia, United States, 22042-3307
Contact: Okasana Shlobin    703-776-2256    oksana.shlobin@inova.org   
Contact: Melodie Wuorinen    (703) 776-6485    melodie.wuorinen@inova.org   
Principal Investigator: Oksana Shlobin, MD         
Sentara Norfolk General Hospital Recruiting
Norfolk, Virginia, United States, 23507
Contact: Michael S Eggert    757-388-5480    msbe@aol.com   
Contact: Melinda Bullivant    (757) 388-4024    mmbulliv@sentara.com   
Principal Investigator: Michael S Eggert, MD         
United States, Washington
Pulmonary & Sleep Research Terminated
Spokane, Washington, United States, 99204
United States, Wisconsin
University of Wisconsin School of Medicine and Public Health Recruiting
Madison, Wisconsin, United States, 53792
Contact: James Runo    608-263-9432    jrr@medicine.wisc.edu   
Contact: Andrea Maser    (608) 265-6544    alm@clinicaltrials.wisc.edu   
Principal Investigator: James Runo, MD         
Aurora Cardiovascular Services Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Ramagopal Tumuluri    414-649-3211    heather.hurley@aurora.org   
Contact: Tracy Graham    (414) 649-6681    tracy.graham@aurora.org   
Principal Investigator: Ramagopal Tumuluri, MD         
Sponsors and Collaborators
Actelion
Investigators
Study Chair: Rajiv Patni, MD Actelion Pharmaceuticals US, Inc
  More Information

No publications provided

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01841762     History of Changes
Other Study ID Numbers: AC-055-401
Study First Received: March 27, 2013
Last Updated: July 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Actelion:
Pulmonary Arterial Hypertension

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014