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Effect of Selexipag on Daily Life Physical Activity of Patients With Pulmonary Arterial Hypertension. (TRACE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03078907
Recruitment Status : Completed
First Posted : March 14, 2017
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
Actelion

Tracking Information
First Submitted Date  ICMJE March 6, 2017
First Posted Date  ICMJE March 14, 2017
Last Update Posted Date March 18, 2020
Actual Study Start Date  ICMJE November 8, 2017
Actual Primary Completion Date February 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2017)
  • Change from baseline to Week 24 in daily time spent in non-sedentary activity [ Time Frame: Baseline and Week 24 (or end of treatment) ]
    This variable will be assessed by actigraphy and will be expressed in minutes. Mean value from the last 14 days period on study treatment will be evaluated and mean change from baseline will be calculated.
  • Change from baseline to Week 24 in percentage of daily time spent in non-sedentary activity [ Time Frame: Baseline and Week 24 (or end of treatment) ]
    This variable will be assessed by actigraphy and is expressed in percentage. Mean value from the last 14 days period on study treatment will be evaluated and mean change from baseline will be calculated.
  • Change from baseline to Week 24 in total daily life physical activity [ Time Frame: Baseline and Week 24 (or end of treatment) ]
    This variable will be assessed by actigraphy and is expressed in counts per minute. Mean value from the last 14 days period on study treatment will be evaluated and mean change from baseline will be calculated.
  • Change from baseline to Week 24 in total sleep time (TST) [ Time Frame: Baseline and Week 24 (or end of treatment) ]
    TST (in minutes) will be assessed by actigraphy. Mean value from the last 14 days period on study treatment will be evaluated and mean change from baseline will be calculated.
  • Change from baseline to Week 24 in wake after sleep onset (WASO) [ Time Frame: Baseline and Week 24 (or end of treatment) ]
    WASO (in minutes) will be assessed by actigraphy. Mean value from the last 14 days period on study treatment will be evaluated and mean change from baseline will be calculated.
  • Change from baseline to Week 24 in number of awakenings [ Time Frame: Baseline and Week 24 (or end of treatment) ]
    This variable will be assessed by actigraphy. Mean value from the last 14 days period on study treatment will be evaluated and mean change from baseline will be calculated.
  • Change from baseline to Week 24 in sleep efficiency (SE) [ Time Frame: Baseline and Week 24 (or end of treatment) ]
    SE (in percentage) will be assessed by actigraphy. Mean value from the last 14 days period on study treatment will be evaluated and mean change from baseline will be calculated.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2017)
  • Change from baseline to Week 24 in World Health Organization Functional Class (WHO FC) [ Time Frame: Baseline and Week 24 (or end of treatment) ]
    The change from baseline in WHO FC will be classified into "Improved", "No change" and "Worsened". The change from baseline in WHO FC will be displayed in a shift table with percentage of participants in each category at Week 24
  • Change from baseline to Week 24 in 6-minute walk distance (6MWD) [ Time Frame: Baseline and Week 24 (or end of treatment) ]
    The 6MWD is the total distance walked during 6 minutes. Mean change from baseline (distance walked at Week 24 minus distance walked at baseline) will be calculated
  • Change from baseline to Week 24 in Borg dyspnea score [ Time Frame: Baseline and Week 24 (or end of treatment) ]
    The Borg dyspneas score is a self-rating scale to evaluate the severity of dyspnea (from 0 "no breathlessness at all" to 10 "very, very severe / maximal"). It will be completed immediately after the 6-minute walk test at Week 24 and at baseline. Mean change from baseline in scoring will be calculated
  • Change from baseline to Week 24in N-terminal pro-brain natriuretic peptide (NT-proBNP) [ Time Frame: Baseline and Week 24 (or end of treatment) ]
    Mean change from baseline in blood concentration of NT-proBNP (value at Week 24 minus value at baseline) will be calculated
  • Change from baseline to Week 24 in cardiovascular symptom domain score of PAH-SYMPACT® [ Time Frame: Baseline and Week 24 (or end of treatment) ]
    PAH-SYMPACT (Pulmonary Arterial Hypertension-Symptoms and Impact) is a self-rating questionnaire administered over a period of 7 days at baseline and at Week 24 to assess PAH-specific symptoms and their physical and cognitive/emotional impact. mean value on each of the 7-day period is calculated for each specific domain score and corresponding mean change from baseline determined
  • Change from baseline to Week 24 in cardiopulmonary symptom domain score of PAH-SYMPACT® [ Time Frame: Baseline and Week 24 (or end of treatment) ]
    PAH-SYMPACT (Pulmonary Arterial Hypertension-Symptoms and Impact) is a self-rating questionnaire administered over a period of 7 days at baseline and at Week 24. mean value on each of the 7-day period is calculated for each specific domain score and corresponding mean change from baseline determined
  • Change from baseline to Week 24 in physical impact domain score of PAH-SYMPACT® [ Time Frame: Baseline and Week 24 (or end of treatment) ]
    PAH-SYMPACT (Pulmonary Arterial Hypertension-Symptoms and Impact) is a self-rating questionnaire administered over a period of 7 days at baseline and at Week 24. mean value on each of the 7-day period is calculated for each specific domain score and corresponding mean change from baseline determined
  • Change from baseline to Week 24 in cognitive/emotional impact domain score of PAH-SYMPACT® [ Time Frame: Baseline and Week 24 (or end of treatment) ]
    PAH-SYMPACT (Pulmonary Arterial Hypertension-Symptoms and Impact) is a self-rating questionnaire administered over a period of 7 days at baseline and at Week 24. mean value on each of the 7-day period is calculated for each specific domain score and corresponding mean change from baseline determined
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Selexipag on Daily Life Physical Activity of Patients With Pulmonary Arterial Hypertension.
Official Title  ICMJE A Multi-center, Double-blind, Placebo-controlled Phase 4 Study in Patients With Pulmonary Arterial Hypertension to Assess the Effect of Selexipag on Daily Life Physical Activity and Patient's Self-reported Symptoms and Their Impacts
Brief Summary The primary objective of this study is to evaluate the effect of selexipag on the physical activity of patients with pulmonary arterial hypertension (PAH) in their daily life, by using a wearable wrist device (actigraph). The actigraph will collect data on daily life physical activity in the patient's real environment. In addition, the PAH symptoms and their impacts will be assessed by using an electronic patient reported outcome measure in the patient's real environment. Patients will be assigned randomly to either selexipag or placebo.
Detailed Description This study is designed as exploratory with the purpose to generate hypotheses on new endpoints
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Pulmonary Arterial Hypertension
Intervention  ICMJE
  • Drug: Selexipag
    Film-coated tablets for oral use; one tablet (200 mcg) to eight tablets (1600 mcg) are administered depending on the individual tolerability.
    Other Names:
    • ACT-293987
    • Uptravi
  • Drug: Placebo
    Matching film coated tablets
Study Arms  ICMJE
  • Experimental: Selexipag
    Selexipag is up-titrated from Day 1 to Week 12 to the individualized highest tolerated dose (HTD), which can range from 200 mcg b.i.d. to 1600 mcg b.i.d., in 200 mcg steps starting with 200 mcg b.i.d. Then, the dose is increased in increments of 200 mcg b.i.d., usually at weekly intervals, depending on the dose tolerability. Up-titration is followed by a stable maintenance treatment period at the highest tolerated dose, from Week 13 to Week 24.
    Intervention: Drug: Selexipag
  • Placebo Comparator: Placebo
    Regimen and titration scheme similar to those in the selexipag group
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 3, 2019)
108
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2017)
100
Actual Study Completion Date  ICMJE February 10, 2020
Actual Primary Completion Date February 10, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female between 18 and 75 years old inclusive.
  • Women of childbearing potential must have a negative serum pregnancy test at planned visits and use an acceptable method of birth control from screening up to 30 days after study treatment discontinuation.
  • Symptomatic pulmonary arterial hypertension (PAH) belonging to one of the following subgroups only:

    • Idiopathic
    • Heritable
    • Drug or toxin induced
    • Associated with one of the following: connective tissue disease; HIV infection; corrected simple congenital heart disease.
  • With the following hemodynamic characteristics assessed by right heart catheterization (RHC) prior to randomization:

    • Mean pulmonary artery pressure (mPAP) ≥ 25 mmHg
    • Pulmonary vascular resistance (PVR) ≥ 240 dyn•sec/cm5 (or 3 Wood Units)
    • Pulmonary artery wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) ≤ 15 mmHg.
  • Treatment with an endothelin receptor antagonist (ERA) for at least 90 days and on a stable dose for 30 days prior to randomization.
  • If an ERA is given in combination with a phosphodiesterase-5 (PDE-5) inhibitor or soluble guanylate cyclase (sGC) stimulator, these treatments must be ongoing for at least 90 days and on a stable dose for 30 days prior to randomization.
  • WHO functional class (FC) II or III at randomization
  • 6-minute walk distance (6MWD) ≥ 100 m at screening.
  • Ability to walk without a walking aid.
  • Valid baseline data for daily life physical activity (DLPA) and PAH-SYMPACT®.

Exclusion Criteria:

  • Patients on a PAH-specific monotherapy targeting the nitric oxide pathway (i.e. PDE-5 inhibitor or sGC stimulator).
  • Patients treated with prostacyclin, prostacyclin analog or selexipag within 3 months prior to screening.
  • Any hospitalization during the last 30 days prior to screening.
  • Severe coronary heart disease or unstable angina.
  • Documented severe hepatic impairment or severe renal insufficiency at screening.
  • Participation in a cardio-pulmonary rehabilitation program based on exercise training within 8 weeks prior to screening
  • Any factor or condition likely to affect full participation in the study or compliance with the protocol (such as adherence to protocol mandated procedures), as judged by the investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   France,   Germany,   Ireland,   Norway,   Portugal,   Sweden,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03078907
Other Study ID Numbers  ICMJE AC-065A404
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Actelion
Study Sponsor  ICMJE Actelion
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Thomas Pfister Actelion
PRS Account Actelion
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP