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CompletedNCT01841762Updated Feb 26, 2019Results posted

Clinical Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument

A Phase 3 interventional study of Macitentan in Pulmonary Arterial Hypertension, sponsored by Actelion. Completed at 81 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-26.

Sponsored by Actelion · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
284
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Pulmonary Arterial Hypertension

Keywords

  • PAH-SYMPACT
  • Pulmonary Arterial Hypertension
  • psychometric instrument
03

In context

Pulmonary Arterial Hypertension

761 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.

This study's enrollment of 284 is above the median of 38 across 509 interventional studies indexed under Pulmonary Arterial Hypertension.

Browse Pulmonary Arterial Hypertension studies →

Lead sponsor

Actelion is the lead sponsor of 140 studies on the registry; 1 is open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 24 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
284 participants (actual)

Study arms

  • Experimental
    Macitentan

    Macitentan tablet, dose of 10 mg, once daily

    Drug: Macitentan

Interventions

  • DrugMacitentan

    Macitentan tablet, dose of 10 mg, once daily

    Also known as: Macitentan / ACT-064992

06

What researchers measure

Primary outcomes

  1. Development and Refinement of the Patient-reported Outcome Measure of Symptoms and Their Impact in PAH (the PAH-SYMPACT)

    Content validity of the PAH-SYMPACT was assessed using item performance, exploratory and confirmatory factor analysis. The final item content and domain structure of PAH-SYMPACT was determined based on these analyses from the Steering Committee (expert clinicians) and findings from the qualitative research done with patients previously.

    Time frame: From Screening Visit (Day -14) to End of Treatment (EOT) Visit (Visit 4, Week 16)

  2. Validation of the Patient-reported Outcome Measure of Symptoms and Their Impact in PAH (the PAH-SYMPACT), With Reliability Assessed Via Test-retest Reliability.

    The reliability of the PAH-SYMPACT is assessed by test-retest reliability. Intra-class correlation coefficients (ICCs) assess test-retest reliability for the symptom and impact part scores as well as domains. ICCs equal to or greater than 0.70 are considered to demonstrate good test-retest reliability for total and domain scores.

    Time frame: From ePRO period 1 (Days -14 to -8) to ePRO period 2 (Days -7 to -1) in screening period.

  3. Validation of the Patient-reported Outcome Measure of Symptoms and Their Impact in PAH (the PAH-SYMPACT), Assessing Internal Consistency Reliability.

    The reliability of the PAH-SYMPACT is assessed by internal consistency reliability. This was determined using Cronbach's alpha-a value on an internal level scale from 0 to 1.0 with higher scores indicating a more-reliable (precise) instrument.

    Time frame: From ePRO period 1 (Days -14 to -8) to ePRO period 2 (Days -7 to -1) in screening period.

Secondary outcomes

  1. Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events, and Adverse Events Resulting in Patient Study Drug Discontinuation Between Time Periods, BL to End of Study Visit (EoS, Week 16+30 Days for Follow-up Safety Visits)

    Safety events are reported and documented as defined in study protocol.

    Time frame: From Day 1 (Baseline Visit) to End of Study visit (EoS).

Other outcomes

  1. Assessment of the Sensitivity to Detect Change in the Symptoms and Impacts Domain Scores of the PAH-SYMPACT From Baseline to Week 16.

    Sensitivity to change is an aspect of construct validity and represents the instrument's ability to detect underlying change. Sensitivity to change was examined to compare the difference in mean score in each domain of the PAH-SYMPACT. The symptoms and impacts domains consisted of 11 items each reported on a 7-point Likert Scale (from 0=no symptom/with no difficulty at all/not at all to 6=very severe symptoms/very much/extremely/not able at all). An average symptoms domain score is determined based on the daily scores of the containing items. An average impacts domain score is determined based on the items in the domain.

    Time frame: From Screening period (Days -7 to -1) to Week 16 (7-day period prior to Week 16 visit).

07

Results

Posted Oct 31, 2018

Participant flow

Seventy-nine sites recruited subjects to reach a total of 284 total enrolled, with 335 subjects entered screening. Institution-based and community clinic sites, with pulmonary arterial hypertension expertise, were included in the study. The first subject, first visit occurred on 25 APR 2013 and last subject, last visit occurred on 05 OCT 2015

Screening Period
Participant flow — Screening Period
MilestoneMacitentan
Started335
Completed284
Not completed51
Withdrew: Other, 2 pah-sympact cycles not complete51
Treatment Period
Participant flow — Treatment Period
MilestoneMacitentan
Started284
Completed252
Not completed32
Withdrew: Adverse event16
Withdrew: Death1
Withdrew: Withdrawal by subject7
Withdrew: Lost to follow-up1
Withdrew: Physician decision2
Withdrew: Other, including non-compliance5
Post-Treatment Safety Follow-Up Period
Participant flow — Post-Treatment Safety Follow-Up Period
MilestoneMacitentan
Started284
Completed269
Not completed15
Withdrew: Death1
Withdrew: Withdrawal by subject7
Withdrew: Lost to follow-up6
Withdrew: Other, administrative error1

Outcome measures

PrimaryDevelopment and Refinement of the Patient-reported Outcome Measure of Symptoms and Their Impact in PAH (the PAH-SYMPACT)

Content validity of the PAH-SYMPACT was assessed using item performance, exploratory and confirmatory factor analysis. The final item content and domain structure of PAH-SYMPACT was determined based on these analyses from the Steering Committee (expert clinicians) and findings from the qualitative research done with patients previously.

Time frame:
From Screening Visit (Day -14) to End of Treatment (EOT) Visit (Visit 4, Week 16)
Reported as:
Number · Items
Development and Refinement of the Patient-reported Outcome Measure of Symptoms and Their Impact in PAH (the PAH-SYMPACT)
ItemsMacitentan
Item number in symptoms part of baseline16
Item number in symptoms part at Week 1611
Item number in impacts part at baseline25
Item number in impacts part at Week 1611
PrimaryValidation of the Patient-reported Outcome Measure of Symptoms and Their Impact in PAH (the PAH-SYMPACT), With Reliability Assessed Via Test-retest Reliability.

The reliability of the PAH-SYMPACT is assessed by test-retest reliability. Intra-class correlation coefficients (ICCs) assess test-retest reliability for the symptom and impact part scores as well as domains. ICCs equal to or greater than 0.70 are considered to demonstrate good test-retest reliability for total and domain scores.

Time frame:
From ePRO period 1 (Days -14 to -8) to ePRO period 2 (Days -7 to -1) in screening period.
Reported as:
Number · Intra-class correlation coefficient
Validation of the Patient-reported Outcome Measure of Symptoms and Their Impact in PAH (the PAH-SYMPACT), With Reliability Assessed Via Test-retest Reliability.
Intra-class correlation coefficientMacitentan
ICCs of Cardiopulmonary Symptoms domain0.94
ICCs of Cardiovascular Symptoms domain0.93
ICCs of Physical Impacts domain0.91
ICCs of Cognitive/Emotional Impacts domain0.84
PrimaryValidation of the Patient-reported Outcome Measure of Symptoms and Their Impact in PAH (the PAH-SYMPACT), Assessing Internal Consistency Reliability.

The reliability of the PAH-SYMPACT is assessed by internal consistency reliability. This was determined using Cronbach's alpha-a value on an internal level scale from 0 to 1.0 with higher scores indicating a more-reliable (precise) instrument.

Time frame:
From ePRO period 1 (Days -14 to -8) to ePRO period 2 (Days -7 to -1) in screening period.
Reported as:
Number · Ratio of variance
Validation of the Patient-reported Outcome Measure of Symptoms and Their Impact in PAH (the PAH-SYMPACT), Assessing Internal Consistency Reliability.
Ratio of varianceMacitentan
Cronbach's Alpha for Cardiopulmonary Symptoms0.81
Cronbach's Alpha for Cardiovascular Symptoms0.88
Cronbach's Alpha for Physical Impacts Domain0.92
Cronbach's Alpha for Cognitive/Emotional Impacts0.87
SecondaryNumber of Participants With Treatment-emergent Adverse Events, Serious Adverse Events, and Adverse Events Resulting in Patient Study Drug Discontinuation Between Time Periods, BL to End of Study Visit (EoS, Week 16+30 Days for Follow-up Safety Visits)

Safety events are reported and documented as defined in study protocol.

Time frame:
From Day 1 (Baseline Visit) to End of Study visit (EoS).
Reported as:
Count of participants · Participants
Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events, and Adverse Events Resulting in Patient Study Drug Discontinuation Between Time Periods, BL to End of Study Visit (EoS, Week 16+30 Days for Follow-up Safety Visits)
ParticipantsMacitentan
Participants with AEs228
Participants with severe intensity AEs36
Participants with SAEs49
Participants prematurely discontinued study drug17
Other pre-specifiedAssessment of the Sensitivity to Detect Change in the Symptoms and Impacts Domain Scores of the PAH-SYMPACT From Baseline to Week 16.

Sensitivity to change is an aspect of construct validity and represents the instrument's ability to detect underlying change. Sensitivity to change was examined to compare the difference in mean score in each domain of the PAH-SYMPACT. The symptoms and impacts domains consisted of 11 items each reported on a 7-point Likert Scale (from 0=no symptom/with no difficulty at all/not at all to 6=very severe symptoms/very much/extremely/not able at all). An average symptoms domain score is determined based on the daily scores of the containing items. An average impacts domain score is determined based on the items in the domain.

Time frame:
From Screening period (Days -7 to -1) to Week 16 (7-day period prior to Week 16 visit).
Reported as:
Median · Score on a scale
Assessment of the Sensitivity to Detect Change in the Symptoms and Impacts Domain Scores of the PAH-SYMPACT From Baseline to Week 16.
Score on a scaleMacitentan
Cardiopulmonary Symptoms domain score at baseline1.0 (0.5 to 1.3)
Cardiopulmonary Symptoms domain score at Week 80.8 (0.4 to 1.2)
Cardiopulmonary Symptoms domain score at Week 160.7 (0.4 to 1.2)
Cardiovascular Symptoms domain score at baseline0.4 (0.1 to 0.7)
Cardiovascular Symptoms domain score at Week 80.2 (0.0 to 0.5)
Cardiovascular Symptoms domain score at Week 160.2 (0.0 to 0.5)
Physical Impacts domain score at baseline1.3 (0.6 to 2.0)
Physical Impacts domain score at Week 81.0 (0.4 to 1.7)
Physical Impacts domain score at Week 160.9 (0.4 to 1.6)
Cogn./Emotional Impacts domain score at baseline0.8 (0.3 to 1.5)
Cogn./Emotional Impacts domain score at Week 80.8 (0.3 to 1.3)
Cogn./Emotional Impacts domain score at Week 160.5 (0.5 to 1.3)

Adverse events

Collected over Treatment-emergent adverse events were collected from study drug initiation until Day 30 after study drug discontinuation.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Macitentan1/284 (0.4%)49/284 (17.3%)228/284 (80.3%)
Most frequent serious events
Showing 10 of 20
Most frequent serious events
EventMacitentan
DyspnoeaRespiratory, thoracic and mediastinal disorders5/284
Chest PainGeneral disorders4/284
PneumoniaRespiratory, thoracic and mediastinal disorders4/284
AnaemiaBlood and lymphatic system disorders3/284
Cardiac FailureCardiac disorders3/284
Cardiac Failure CongestiveCardiac disorders3/284
Fluid OverloadGeneral disorders3/284
HypoxiaRespiratory, thoracic and mediastinal disorders3/284
Renal Failure AcuteRenal and urinary disorders3/284
Small Intestinal ObstructionGastrointestinal disorders3/284
Most frequent other events
Most frequent other events
EventMacitentan
Oedema peripheralBlood and lymphatic system disorders50/284
HeadacheNervous system disorders36/284
DyspnoeaRespiratory, thoracic and mediastinal disorders34/284
CoughRespiratory, thoracic and mediastinal disorders26/284
Nasal congestionRespiratory, thoracic and mediastinal disorders23/284
FatigueGeneral disorders22/284
DizzinessEar and labyrinth disorders19/284
Upper Respiratory Tract InfectionRespiratory, thoracic and mediastinal disorders19/284
NauseaGeneral disorders17/284
AnaemiaBlood and lymphatic system disorders16/284

Baseline characteristics

The number of subjects who dosed on macitentan in the trial was 284.

Age, Categorical
Age, Categorical(Participants)Macitentan
<=18 years0
Between 18 and 65 years167
>=65 years117
Age, Continuous
Age, Continuous(Years)Macitentan
Mean59.7 (52.0 to 69.0)
Sex: Female, Male
Sex: Female, Male(Participants)Macitentan
Female223
Male61
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Macitentan
Hispanic or Latino27
Not Hispanic or Latino257
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Macitentan
American Indian or Alaska Native2
Asian8
Native Hawaiian or Other Pacific Islander1
Black or African American35
White228
More than one race10
Unknown or Not Reported0
08

Study locations

81 sites
  • Cardiovascular Associates of the Southeast, LLC
    Birmingham, Alabama 35243, United States
  • University of Alabama at Birmingham
    Birmingham, Alabama 35294, United States
  • Pulmonary Associates, PA
    Phoenix, Arizona 85006-2611, United States
  • Mayo Clinic Arizona
    Phoenix, Arizona 85054-4502, United States
  • Cedars-Sinai Medical Center
    Beverly Hills, California 90211, United States
  • UCSF Fresno
    Fresno, California 93701, United States
  • UCSD Medical Center, Pulmonary Department
    La Jolla, California 92093, United States
  • VAGLAHS, VA Greater LA Healthcare System
    Los Angeles, California 90073, United States
  • University of California Los Angeles
    Los Angeles, California 90095, United States
  • University of California San Francisco Medical Center
    San Francisco, California 94143, United States
  • Stanford University
    Stanford, California 94305-2200, United States
  • Los Angeles Biomedical Research Institute
    Torrance, California 90502, United States
  • University of Colorado
    Aurora, Colorado 80045, United States
  • MedStar Georgetown University Hospital
    Washington, District of Columbia 20007, United States
  • Medstar Washington Hospital Center
    Washington, District of Columbia 20010, United States
  • Bay Area Cardiology Associates, P.A.
    Brandon, Florida 33511, United States
  • University of Florida Academic Health Center
    Gainesville, Florida 32610, United States
  • University of Florida College of Medicine, Jacksonville
    Jacksonville, Florida 32209, United States
  • Mayo Clinic
    Jacksonville, Florida 32224-1865, United States
  • Cleveland Clinic Florida
    Weston, Florida 33331-3609, United States
  • Georgia Regents University
    Augusta, Georgia 30912, United States
  • Georgia Clinical Research
    Austell, Georgia 30106, United States
  • Northwestern University
    Chicago, Illinois 60611, United States
  • University of Chicago Medical
    Chicago, Illinois 60637, United States
  • Advocate Health and Hospitals Corporation
    Oakbrook Terrace, Illinois 60181, United States
  • Chest Infectious Diseases and Critical Care Associates, PC
    Des Moines, Iowa 50325-7046, United States
  • University of Iowa Hospitals & Clinics
    Iowa City, Iowa 52242, United States
  • Iowa City Heart Center
    Iowa City, Iowa 52245, United States
  • University of Kansas Medical Center
    Kansas City, Kansas 66160-0001, United States
  • Veritas Clinical Specialties
    Topeka, Kansas 66606, United States
  • Kentuckiana Pulmonary Associates
    Louisville, Kentucky 40202, United States
  • University of Louisville
    Louisville, Kentucky 40202, United States
  • University of Maryland Medical Center
    Baltimore, Maryland 21201, United States
  • Johns Hopkins University
    Baltimore, Maryland 21205, United States
  • Tufts Medical Center
    Boston, Massachusetts 02111, United States
  • Boston University Medical Center
    Boston, Massachusetts 02118, United States
  • University of Michigan
    Ann Arbor, Michigan 48109-5644, United States
  • Beaumont Hospital
    Troy, Michigan 48085, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Midwest Pulmonary Consultants
    Kansas City, Missouri 64111, United States
  • Washington University School of Medicine
    Saint Louis, Missouri 63110, United States
  • Mercy Clinic Pulmonology
    Saint Louis, Missouri 63141, United States
  • Clayton Sleep Institute
    Saint Louis, Missouri 63143, United States
  • Ferrell-Duncan Clinic
    Springfield, Missouri 65807, United States
  • Nebraska Pulmonary Specialties
    Lincoln, Nebraska 68506, United States
  • University of Nebraska Medical Center
    Omaha, Nebraska 68198, United States
  • Pulmonary and Critical Care Associates
    Union, New Jersey 07083, United States
  • Montefiore Medical Center, Weiler Division
    Bronx, New York 10461, United States
  • Buffalo General Medical Center
    Buffalo, New York 14203, United States
  • Winthrop University Hospital
    Mineola, New York 11501, United States
  • North Shore-LIJ/Advance Lung Disease Clinic
    New Hyde Park, New York 11040, United States
  • Beth Israel Medical Center
    New York, New York 10003, United States
  • Columbia University Medical Center
    New York, New York 10032, United States
  • University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina 27599, United States
  • Novant Health Pulmonary and Critical Care
    Matthews, North Carolina 28105, United States
  • The Christ Hospital
    Cincinnati, Ohio 45219, United States
  • UC Health/University of Cincinnati
    Cincinnati, Ohio 45267, United States
  • Cleveland Clinic
    Cleveland, Ohio 45219, United States
  • Davis Heart & Lung Research Institute
    Columbus, Ohio 43210-1252, United States
  • The Ohio State University
    Columbus, Ohio 43221, United States
  • University of Oklahoma Health Sciences Center
    Oklahoma City, Oklahoma 73104, United States
  • The Oregon Clinic
    Portland, Oregon 97220, United States
  • CDA for Oregon Pulmonary Associate
    Portland, Oregon 97225, United States
  • Oregon Health and Science University
    Portland, Oregon 97239, United States
  • Thomas Jefferson University, Division on Pulmonary and Critical Care
    Philadelphia, Pennsylvania 19107-5109, United States
  • Temple Lung Center
    Philadelphia, Pennsylvania 19140, United States
  • UPMC
    Pittsburgh, Pennsylvania 15123, United States
  • Allegheny General Hospital
    Pittsburgh, Pennsylvania 15212-4756, United States
  • Berks Schuylkill Respiratory Specialists, Ltd.
    Wyomissing, Pennsylvania 19610, United States
  • Wellspan Lung, Sleep and Critical Care
    York, Pennsylvania 17402-8200, United States
  • Sioux Falls Cardiovascular, PC
    Sioux Falls, South Dakota 57108, United States
  • Baylor Research Institute (BRI)
    Dallas, Texas 75204, United States
  • UT Southwestern Medical Center
    Dallas, Texas 75390-8550, United States
  • Baylor College of Medicine
    Houston, Texas 77030-2348, United States
  • The University of Texas Health Science Center at Houston
    Houston, Texas 77030, United States
  • Scott & White Memorial Hospital
    Temple, Texas 76508, United States
  • Inova Heart and Vascular Institue / Inova Fairfax Hospital
    Falls Church, Virginia 22042-3307, United States
  • Sentara Norfolk General Hospital
    Norfolk, Virginia 23507, United States
  • Pulmonary & Sleep Research
    Spokane, Washington 99204, United States
  • University of Wisconsin School of Medicine and Public Health
    Madison, Wisconsin 53792, United States
  • Aurora Cardiovascular Services
    Milwaukee, Wisconsin 53215, United States
09

References and documents

Publications

  • 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. PubMed 29705220 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01841762
Lead sponsor
Actelion
Responsible party
Sponsor
First posted
Apr 29, 2013
Start date
Apr 1, 2013
Primary completion
Nov 1, 2015
Completion
Nov 1, 2015
Results posted
Oct 31, 2018
Last update
Feb 26, 2019

Study contacts

Alain Romero, PharmD, PhD
study chair · Actelion Pharmaceuticals US, Inc
Gary Palmer, MD, MBA
study chair · Actelion Pharmaceuticals US, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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