Clinical Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument
NCT ID: NCT01841762
Last Updated: 2019-02-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
284 participants
INTERVENTIONAL
2013-04-01
2015-11-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Macitentan
Macitentan tablet, dose of 10 mg, once daily
Macitentan
Macitentan tablet, dose of 10 mg, once daily
Interventions
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Macitentan
Macitentan tablet, dose of 10 mg, once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Actelion
INDUSTRY
Responsible Party
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Principal Investigators
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Alain Romero, PharmD, PhD
Role: STUDY_CHAIR
Actelion Pharmaceuticals US, Inc
Gary Palmer, MD, MBA
Role: STUDY_CHAIR
Actelion Pharmaceuticals US, Inc.
Locations
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Cardiovascular Associates of the Southeast, LLC
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Pulmonary Associates, PA
Phoenix, Arizona, United States
Mayo Clinic Arizona
Phoenix, Arizona, United States
Cedars-Sinai Medical Center
Beverly Hills, California, United States
UCSF Fresno
Fresno, California, United States
UCSD Medical Center, Pulmonary Department
La Jolla, California, United States
VAGLAHS, VA Greater LA Healthcare System
Los Angeles, California, United States
University of California Los Angeles
Los Angeles, California, United States
University of California San Francisco Medical Center
San Francisco, California, United States
Stanford University
Stanford, California, United States
Los Angeles Biomedical Research Institute
Torrance, California, United States
University of Colorado
Aurora, Colorado, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
Bay Area Cardiology Associates, P.A.
Brandon, Florida, United States
University of Florida Academic Health Center
Gainesville, Florida, United States
University of Florida College of Medicine, Jacksonville
Jacksonville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Georgia Regents University
Augusta, Georgia, United States
Georgia Clinical Research
Austell, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago Medical
Chicago, Illinois, United States
Advocate Health and Hospitals Corporation
Oakbrook Terrace, Illinois, United States
Chest Infectious Diseases and Critical Care Associates, PC
Des Moines, Iowa, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
Iowa City Heart Center
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Veritas Clinical Specialties
Topeka, Kansas, United States
Kentuckiana Pulmonary Associates
Louisville, Kentucky, United States
University of Louisville
Louisville, Kentucky, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Johns Hopkins University
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Boston University Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Beaumont Hospital
Troy, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Midwest Pulmonary Consultants
Kansas City, Missouri, United States
Ferrell-Duncan Clinic
Springfield, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Mercy Clinic Pulmonology
St Louis, Missouri, United States
Clayton Sleep Institute
St Louis, Missouri, United States
Nebraska Pulmonary Specialties
Lincoln, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Pulmonary and Critical Care Associates
Union, New Jersey, United States
Buffalo General Medical Center
Buffalo, New York, United States
Winthrop University Hospital
Mineola, New York, United States
North Shore-LIJ/Advance Lung Disease Clinic
New Hyde Park, New York, United States
Beth Israel Medical Center
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Montefiore Medical Center, Weiler Division
The Bronx, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Novant Health Pulmonary and Critical Care
Matthews, North Carolina, United States
The Christ Hospital
Cincinnati, Ohio, United States
UC Health/University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Davis Heart & Lung Research Institute
Columbus, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
The Oregon Clinic
Portland, Oregon, United States
CDA for Oregon Pulmonary Associate
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Thomas Jefferson University, Division on Pulmonary and Critical Care
Philadelphia, Pennsylvania, United States
Temple Lung Center
Philadelphia, Pennsylvania, United States
UPMC
Pittsburgh, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Berks Schuylkill Respiratory Specialists, Ltd.
Wyomissing, Pennsylvania, United States
Wellspan Lung, Sleep and Critical Care
York, Pennsylvania, United States
Sioux Falls Cardiovascular, PC
Sioux Falls, South Dakota, United States
Baylor Research Institute (BRI)
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Scott & White Memorial Hospital
Temple, Texas, United States
Inova Heart and Vascular Institue / Inova Fairfax Hospital
Falls Church, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Pulmonary & Sleep Research
Spokane, Washington, United States
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States
Aurora Cardiovascular Services
Milwaukee, Wisconsin, United States
Countries
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References
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Chin KM, Gomberg-Maitland M, Channick RN, Cuttica MJ, Fischer A, Frantz RP, Hunsche E, Kleinman L, McConnell JW, McLaughlin VV, Miller CE, Zamanian RT, Zastrow MS, Badesch DB. Psychometric Validation of the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Questionnaire: Results of the SYMPHONY Trial. Chest. 2018 Oct;154(4):848-861. doi: 10.1016/j.chest.2018.04.027. Epub 2018 Apr 26.
Other Identifiers
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AC-055-401
Identifier Type: -
Identifier Source: org_study_id
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