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Trial record 1 of 1 for:    NCT03078907
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Effect of Selexipag on Daily Life Physical Activity of Patients With Pulmonary Arterial Hypertension. (TRACE)

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ClinicalTrials.gov Identifier: NCT03078907
Recruitment Status : Recruiting
First Posted : March 14, 2017
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Actelion

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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: Selexipag Drug: Placebo Phase 4

Detailed Description:
This study is designed as exploratory with the purpose to generate hypotheses on new endpoints

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : November 8, 2017
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : February 28, 2020


Arm Intervention/treatment
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.
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

Placebo Comparator: Placebo
Regimen and titration scheme similar to those in the selexipag group
Drug: Placebo
Matching film coated tablets




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03078907


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

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Sponsors and Collaborators
Actelion
Investigators
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Study Director: Thomas Pfister Actelion

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Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT03078907     History of Changes
Other Study ID Numbers: AC-065A404
First Posted: March 14, 2017    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Actelion:
daily life
physical activity
actigraphy
PAH-SYMPACT

Additional relevant MeSH terms:
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Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Selexipag
Antihypertensive Agents