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 April 2015 by Actelion
Information provided by (Responsible Party):
Actelion Identifier:
First received: March 27, 2013
Last updated: April 9, 2015
Last verified: April 2015

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: April 2015
Estimated Primary Completion Date: April 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


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

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 identifier: NCT01841762

Contact: Scott Tsurutani 650 808 - 6586

  Hide Study Locations
United States, Alabama
Cardiovascular Associates of the Southeast, LLC Recruiting
Birmingham, Alabama, United States, 35243
Contact: Barry Rayburn    205-599-6374   
Contact: Vontrina Jones    205-599-6374   
Principal Investigator: Barry Rayburn, MD         
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Jose Tallaj    205-934-3624   
Contact: Gregory Wright    (205) 934-8767   
Principal Investigator: Jose Tallaj, MD         
United States, Arizona
Mayo Clinic Arizona Recruiting
Phoenix, Arizona, United States, 85054-4502
Contact: Robert L Scott    480-342-2376   
Contact: Arcenio Galindo    (480) 342-3987   
Principal Investigator: Robert L Scott, MD         
Pulmonary Associates, PA Recruiting
Phoenix, Arizona, United States, 85006-2611
Contact: David M Baratz    602-258-4951   
Contact: LiYi Fu    (602) 346-4743   
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   
Contact: Lucy Garcia    (310) 248-7134   
Principal Investigator: Antoine Hage, MD         
UCSF Fresno Recruiting
Fresno, California, United States, 93701
Contact: Vijay Balasubramanian    559-499-6637   
Contact: Sonia Garcia    (559) 499-6637   
Principal Investigator: Vijay Balasubramanian, MD         
UCSD Medical Center, Pulmonary Department Recruiting
La Jolla, California, United States, 92093
Contact: David Poch    858-657-7150      
Contact: Gina Balzon    858-657-7127   
Principal Investigator: David Poch, MD         
University of California Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Rajan Saggar    310-267-7492   
Contact: Nick Williams    310-794-0435   
Principal Investigator: Rajan Saggar, MD         
VAGLAHS, VA Greater LA Healthcare System Recruiting
Los Angeles, California, United States, 90073
Contact: Shelley Shapiro    310-268-4314   
Contact: Harold Te    310-279-4314   
Principal Investigator: Shelley Shaprio, MD         
University of California San Francisco Medical Center Recruiting
San Francisco, California, United States, 94143
Contact: Munir Janmohamed   
Contact: Diana Hamilton    415-514-1125   
Principal Investigator: Munir Janmohamed, MD         
Stanford University Recruiting
Stanford, California, United States, 94305-2200
Contact: Roham Zamanian    650-725-5495   
Contact: Val Scott    (650) 725-9861   
Principal Investigator: Roham Zamanian, MD         
Los Angeles Biomedical Research Institute Recruiting
Torrance, California, United States, 90502
Contact: Ronald Oudiz    310-222-2515   
Contact: Joy Beckmann    (310) 222-3560   
Principal Investigator: Ronald Oudiz, MD         
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: David Badesch    720-848-6518   
Contact: Brenda Kuiphoff    (720) 848-6541   
Principal Investigator: David Badesch, MD         
United States, District of Columbia
MedStar Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Contact: Tunay Kuru    202-444-8830   
Contact: Michele Cooney    202-444-4982   
Principal Investigator: Tunay Kuru, MD         
Medstar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: George Ruiz    202-877-8085   
Contact: Margaret Kildee    (202) 877-0613   
Principal Investigator: George Ruiz, MD         
United States, Florida
Bay Area Cardiology Associates, P.A. Recruiting
Brandon, Florida, United States, 33511
Contact: Robert Dewhurst    813-684-6000   
Contact: Trudy Foster    (813) 684-6000 x264   
Principal Investigator: Robert Dewhurst, MD         
University of Florida Academic Health Center Recruiting
Gainesville, Florida, United States, 32610
Contact: Hassan Alnuaimat    352-273-8737   
Contact: Christina Eagan    (352) 273-8990   
Principal Investigator: Hassan Alnuaimat, MD         
University of Florida College of Medicine, Jacksonville Recruiting
Jacksonville, Florida, United States, 32209
Contact: Abubakr Bajwa    904-244-1106   
Contact: Minal Patel    904-244-1106   
Principal Investigator: Abubakr Bajwa, MD         
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224-1865
Contact: Charles Burger    904-953-2000   
Contact: Shannon Kennedy    (904) 953-8557   
Principal Investigator: Charles Burger, MD         
Cleveland Clinic Florida Recruiting
Weston, Florida, United States, 33331-3609
Contact: Franck Rahaghi    954-659-5450   
Contact: Calvin Killingbeck    (954) 659-6247   
Principal Investigator: Franck Rahaghi, MD         
United States, Georgia
Georgia Regents University Recruiting
Augusta, Georgia, United States, 30912
Contact: James R Gossage    706-721-0470   
Contact: Melissa James    (706) 721-8391   
Principal Investigator: James R Gossage, MD         
Georgia Clinical Research Recruiting
Austell, Georgia, United States, 30106
Contact: Chad Miller    770-745-1404 ext 2   
Contact: Kristen Burks    770-745-1404 ext 2   
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   
Contact: Cherylanne Glassner    (773) 834-5672   
Principal Investigator: Mardi Gomberg-Maitland, MD         
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Michael Cuttica    312-695-4834   
Contact: Margaret Travis    312-695-2269   
Principal Investigator: Michael Cuttica, MD         
Advocate Health and Hospitals Corporation Recruiting
Oakbrook Terrace, Illinois, United States, 60181
Contact: Muhyaldeen Dia    708-636-7575   
Contact: Maureen Panella    (708) 636-7575   
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   
Contact: Mary Ann Smith    (515) 224-1777   
Principal Investigator: Maxwell Cosmic, MD         
Iowa City Heart Center Terminated
Iowa City, Iowa, United States, 52245
University of Iowa Hospitals & Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Linda Marie Cadaret    319-356-1616   
Contact: Page Scovel    (319)3848005   
Principal Investigator: Linda Marie Cardaret, MD         
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160-0001
Contact: Leslie Spikes    913-588-6045   
Contact: Marla Watson    (913) 588-4022   
Principal Investigator: Leslie Spikes, MD         
Veritas Clinical Specialties Recruiting
Topeka, Kansas, United States, 66606
Contact: William Leeds    785-354-0735   
Contact: Amy Lutz    (785) 354-0735   
Principal Investigator: William Leeds, MD         
United States, Kentucky
Kentuckiana Pulmonary Associates Recruiting
Louisville, Kentucky, United States, 40202
Contact: Wesley McConnell    502-587-8000   
Contact: Kim Hobbs    502-587-8000 ext 125   
Principal Investigator: Wesley McConnell, MD         
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Jimmy Smith    502-852-5841   
Contact: Elizabeth McDaniel    (502) 852-5841      
Principal Investigator: Jimmy Smith, MD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Stephen Mathai    410-614-1648   
Contact: Erica Pullins    (410) 614-1316   
Principal Investigator: Stephen Mathai, MD         
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Gautam Ramani    410-328-4394   
Contact: Lioubov Poliakova    (410) 328-6885   
Principal Investigator: Gautam Ramani, MD         
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Nicholas Hill    617-636-4288   
Contact: Karen Visnaw    (617) 636-1334   
Principal Investigator: Nicholas Hill, MD         
Boston University Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Harrison Farber    617-638-4860   
Contact: Kimberly Finch    (617) 638-4475   
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;   
Contact: Ann Johnson    734-936-5383   
Principal Investigator: Vallerie McLaughlin, MD         
Beaumont Hospital Recruiting
Troy, Michigan, United States, 48085
Contact: Samuel Allen    248-964-9719   
Contact: Coleen Tessmar    (248) 964-8524   
Principal Investigator: Samuel Allen, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Robert Frantz    507-284-2511   
Contact: LuAnne Koenig    (507) 284-4298   
Principal Investigator: Robert Frantz, MD         
United States, Missouri
Midwest Pulmonary Consultants Terminated
Kansas City, Missouri, United States, 64111
Clayton Sleep Institute Terminated
Saint Louis, Missouri, United States, 63143
Ferrell-Duncan Clinic Terminated
Springfield, Missouri, United States, 65807
Mercy Clinic Pulmonology Recruiting
St. Louis, Missouri, United States, 63141
Contact: George Matuschak    314-251-4966   
Contact: Katie Krause    (314) 251-5653   
Principal Investigator: George Matuschak, MD         
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Murali Chakinala    314-454-8766   
Contact: Ellen Newton-Lovato    (314) 454-8717   
Principal Investigator: Murali Chakinala, MD         
United States, Nebraska
Nebraska Pulmonary Specialties Terminated
Lincoln, Nebraska, United States, 68506
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Austin Thompson III    402-559-3777   
Contact: Jane Lane    (402) 559-7555   
Principal Investigator: Austin Thompson III, MD         
United States, New Jersey
Pulmonary and Critical Care Associates Terminated
Union, New Jersey, United States, 07083
United States, New York
Montefiore Medical Center, Weiler Division Terminated
Bronx, New York, United States, 10461
Buffalo General Medical Center Recruiting
Buffalo, New York, United States, 14203
Contact: William Gibbons    716-859-2271   
Contact: Rick Rejman    (716) 878-3320   
Principal Investigator: William Gibbons, MD         
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Shilpa Desouza    516-663-9582;   
Contact: Kimberly Byrnes    (516) 663-9582   
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   
Contact: Sameer Verma    (516) 465-5437;   
Principal Investigator: Arunabh Talwar, MD         
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Erika Berman-Rosenzweig    212-305-4436   
Contact: Candix Yanes    (212) 305-4436   
Principal Investigator: Erika Berman-Rosenzweig, MD         
Beth Israel Medical Center Recruiting
New York, New York, United States, 10003
Contact: Roxana Sulica    212-241-3913   
Contact: Rebecca Fenton    (212) 844-8263   
Principal Investigator: Roxana Sulica, 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   
Contact: Sarah McGee    (919) 966-2531   
Principal Investigator: Hubert Ford, MD         
Novant Health Pulmonary and Critical Care Recruiting
Matthews, North Carolina, United States, 28105
Contact: Carl Smart    704-264-1400   
Contact: Christine Mackey    (704) 574-5157   
Principal Investigator: Carl Smart, MD         
United States, Ohio
The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Peter Engel    859-572-7267   
Contact: Nancy Wagner   
Principal Investigator: Peter Engel, MD         
UC Health/University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Jean M Elwing    513-558-4831   
Contact: Brandy Alexander    (513) 558-0027   
Principal Investigator: Jean M Elwing, MD         
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 45219
Contact: Joseph Parambil    216-445-2610   
Contact: Kasi Timmerman    (216) 444-2140   
Principal Investigator: Omar Minai, MD         
The Ohio State University Recruiting
Columbus, Ohio, United States, 43221
Contact: Namita Sood    614-293-4925   
Contact: Stephen Deffenbaugh    (614) 293-3351   
Principal Investigator: Namita Sood, MD         
Davis Heart & Lung Research Institute Recruiting
Columbus, Ohio, United States, 43210-1252
Contact: Curtis J Daniels    614-293-4967   
Contact: Michelle Bright    (614) 292-3496   
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   
Contact: Diane Snelson    503-631-4491   
Principal Investigator: John A Butler, MD         
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Akram Khan    503-494-4493   
Contact: Raeesa Khalid    (503) 494-9570   
Principal Investigator: Akram Khan, MD         
The Oregon Clinic Recruiting
Portland, Oregon, United States, 97220
Contact: Wayne Strauss    503-963-3030   
Contact: Arlena Loos    (503) 963-3183   
Principal Investigator: Wayne Strauss, MD         
United States, Pennsylvania
Temple Lung Center Terminated
Philadelphia, Pennsylvania, United States, 19140
Thomas Jefferson University, Division on Pulmonary and Critical Care Recruiting
Philadelphia, Pennsylvania, United States, 19107-5109
Contact: Michael Scharf    215-955-6591   
Contact: Lisa Pawlowski    (215) 955-2213   
Principal Investigator: Michael Scharf, MD         
UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15123
Contact: David Ishizawar    412-802-3131   
Contact: Mary Pollera    (412) 647-2820   
Principal Investigator: David Ishizawar, MD         
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212-4756
Contact: Amresh Raina    412-359-4760   
Contact: Joan Rossi    (412) 359-4760   
Principal Investigator: Amresh Raina, MD         
Berks Schuylkill Respiratory Specialists, Ltd. Terminated
Wyomissing, Pennsylvania, United States, 19610
Wellspan Lung, Sleep and Critical Care Recruiting
York, Pennsylvania, United States, 17402-8200
Contact: Dmitriy Zubkus    717-851-2465   
Contact: Elizabeth Fisher    (717) 851-2465   
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   
Contact: Nancy Nelson    (605) 274-6300   
Principal Investigator: Kevin Vaska, MD         
United States, Texas
Baylor Research Institute (BRI) Terminated
Dallas, Texas, United States, 75204
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390-8550
Contact: Kelly Chin    214-645-6486   
Contact: Jacqueline Quivers    (214) 645-6489   
Principal Investigator: Kelly Chin, MD         
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Bela Patel    713-500-6838   
Contact: Kristi Morin    (713) 500-6851   
Principal Investigator: Bela Patel, MD         
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030-2348
Contact: Zennat Safdar    713-798-2400   
Contact: Jennifer L Lee    (713) 798-2400   
Principal Investigator: Zeenat Safdar, MD         
Scott & White Memorial Hospital Recruiting
Temple, Texas, United States, 76508
Contact: Christopher Spradley    254-724-3227   
Contact: Lydia Clipper    (254) 724-6750   
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   
Contact: Melodie Wuorinen    (703) 776-6485   
Principal Investigator: Oksana Shlobin, MD         
Sentara Norfolk General Hospital Recruiting
Norfolk, Virginia, United States, 23507
Contact: Michael S Eggert    757-388-5480   
Contact: Melinda Bullivant    (757) 388-4024   
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   
Contact: Andrea Maser    (608) 265-6544   
Principal Investigator: James Runo, MD         
Aurora Cardiovascular Services Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Ramagopal Tumuluri    414-649-3211   
Contact: Tracy Graham    (414) 649-6681   
Principal Investigator: Ramagopal Tumuluri, MD         
Sponsors and Collaborators
Study Chair: Alain Romero, PharmD, PhD Actelion Pharmaceuticals US, Inc
  More Information

No publications provided

Responsible Party: Actelion Identifier: NCT01841762     History of Changes
Other Study ID Numbers: AC-055-401
Study First Received: March 27, 2013
Last Updated: April 9, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Actelion:
Pulmonary Arterial Hypertension

Additional relevant MeSH terms:
Cardiovascular Diseases
Vascular Diseases processed this record on April 26, 2015