Pulmonary Arterial HypertensionPhase 4TRACENCT03078907
Effect of Selexipag on Daily Life Physical Activity of Patients With Pulmonary Arterial Hypertension.
A Phase 4 study testing Selexipag in people with Pulmonary Arterial Hypertension, run by Actelion at 39 sites in 10 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Selexipag
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 39 sitesin 10 countries
- Study dates
- 8 Nov 2017to 10 Feb 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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®.
Who cannot join
- 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.
Trial locations and contacts
39 sites in 10 countries.
39 sites in 10 countries
United States15 sites
Northside Hospital
Atlanta, Georgia, 30342
Tufts Medical Center, Pulmonary/Critical Care & Sleep
Boston, Massachusetts, 02111
UNC Pulmonary Speciality Clinic
Chapel Hill, North Carolina, 27599
University of Cincinnati, Heart, Lung and Vascular Institute
Cincinnati, Ohio, 45267-0564
CCF- Akron General Medical Hospital
Cleveland, Ohio, 44307
Duke University School of Medicine, Duke Pulmonary Vascular Disease center
Durham, North Carolina, 27710
Kentuckiana Pulmonary Research Center
Louisville, Kentucky, 40202
NYU Winthrop Hospital
Mineola, New York, 11501
Vanderbilt University Medical Center, Care Medicine
Nashville, Tennessee, 37232-2650
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112
University of Nebraska Medical Center, Pulmonary, Critical Care & Sleep Medicine Division
Omaha, Nebraska, 68198
University of Pennsylvania, Pulmonary Vascular Disease Program
Philadelphia, Pennsylvania, 19104
Methodist Clinical Trials
San Antonio, Texas, 78229
University of Texas Health Science Center (San Antonio)
San Antonio, Texas, 78229
LA Biomedical Research Institute
Torrance, California, 90502
United Kingdom7 sites
Papworth Hospital, Pulmonary Vascular Disease Unit
Cambridge, Cb23 3RE
Golden Jubilee National Hospital, Scottish Pulmonary Vascular Unit
Clydebank, G81 4DY
The Royal Free Hospital, Cardiology Department
London, NW3 2QG
Royal Brompton Hospital, Hypertension
London, SW3 6NP
Hammersmith Hospital
London, W12 0HS
Freeman Hospital, Cardiothoracic Department
Newcastle upon Tyne, NE7 7DN
Royal Hallamshire Hospital, Pulmonary Vascular Medicine
Sheffield, S10 2JF
Germany4 sites
Herzzentrum der Universität zu Köln, Klinik III für Innere Medizin
Cologne, 50937
Universitätsklinikum Giessen
Giessen, 35392
Universitätsklinikum Leipzig AöR, Abteilung Pneumologie
Leipzig, 04103
Katholisches Klinikum Lünen/Werne GmbH, Haus E
Lünen, 44534
France3 sites
Hôpital Bicêtre, ervice de Pneumologie et Réanimation respiratoire
Le Kremlin-Bicêtre, 94270
CHRU de Lille - Hôpital Albert Calmette, Service de cardiologie
Lille, 59000
Hospital Larrey CHU de Toulouse
Toulouse, 31059
Austria2 sites
Medizinische Universität Innsbruck (MUI), Abt. für Pneumologie, Haus 2
Innsbruck, 06020
Krankenhaus der Elisabethinen, Servicestelle Klinische Studien
Linz, 4020
Portugal2 sites
Centro Hospitalar e Universitário de Coimbra, Serviço de Cardiologia
Coimbra, 3000-075
Hospital Geral de Santo António-DEFI
Porto, 4099-001
Sweden2 sites
Sahlgrenska University Hospital, Gothenburg
Gothenburg, 413 45
Skåne University Hospital, VO Hjärt och Lungmedicin
Lund, 221 85
Switzerland2 sites
Kantonsspital St. Gallen, Klinik für Pneumologie und Schlafmedizin
Sankt Gallen, 9007
Universitaetsspital Zurich, Klinik für Pneumologie C HOER 11
Zurich, 8091
About this study
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
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.
Read the detailed description
This study is designed as exploratory with the purpose to generate hypotheses on new endpoints
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Selexipag, Placebo
- Keywords
- daily life, physical activity, actigraphy, PAH-SYMPACT
- Medical subject headings
- Pulmonary Arterial Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelexipagDrug
Also called ACT-293987, Uptravi
Film-coated tablets for oral use; one tablet (200 mcg) to eight tablets (1600 mcg) are administered depending on the individual tolerability.
PlaceboDrug
Matching film coated tablets
| Study group | Role | What they receive |
|---|---|---|
| Selexipag | Experimental | 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. Receives: Drug: Selexipag |
| Placebo | Placebo comparator | Regimen and titration scheme similar to those in the selexipag group Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 24 in Actigraphy Assessed Daily Life Physical Activity (DLPA) for Variables Expressed in Minutes
Change from baseline to Week 24 of the DLPA activity parameters for daily time spent in non-sedentary activity (NSA) (as defined by Freedson '98 and Koster '16) and daily time spent in moderate-to-vigorous physical activity (MVPA) as defined by Freedson '98 were reported. These variables were assessed by actigraphy and were expressed in minutes. Freedson 1998 established ranges of activity counts obtained from a hip worn accelerometer corresponding to commonly employed MET categories. Based on this work, threshold between sedentary and NSA was defined. This threshold is often referred to as Freedson's 1998 publication. Koster 2016 defined the threshold between sedentary and NSA based on wrist-worn accelerometers on non-dominant hand, respectively. Positive change from baseline means improvement.
Measured: Baseline and Week 24 (data analysis was done during 14-Days each for Baseline and for Week 24 and mean value reported)
Change From Baseline to Week 24 in Actigraphy DLPA for Variables Expressed in Percentage (%)
Change from baseline to Week 24 of the DLPA activity parameters for daily time spent in non-sedentary activity (NSA) (Freedson '98), daily time spent in moderate-to-vigorous physical activity (MVPA) (Freedson '98) and dailytime spent in NSA (Koster '16) were reported. These variables were assessed by actigraphy and were expressed in percentage (%). Freedson 1998 established ranges of activity counts obtained from a hip worn accelerometer corresponding to commonly employed MET categories. Based on this work, threshold between sedentary and NSA was defined. This threshold is often referred to as Freedson's 1998 publication. Koster 2016 defined the threshold between sedentary and NSA based on wrist-worn accelerometers on non-dominant hand, respectively. Positive change from baseline means improvement.
Measured: Baseline and Week 24 (data analysis was done during 14-Days each for Baseline and for Week 24 and mean value reported)
Change From Baseline to Week 24 in Actigraphy DLPA for Variables Expressed in Counts Per Minute (Counts/Minute)
Change from baseline to Week 24 of the DLPA activity parameter for total daily activities and NSA (Koster '16) were reported. These variables were assessed by actigraphy and were expressed in counts/minutes. Koster 2016 defined the threshold between sedentary and NSA based on wrist-worn accelerometers on non-dominant hand, respectively. Positive change from baseline means improvement.
Measured: Baseline and Week 24 (data analysis was done during 14-Days each for Baseline and for Week 24 and mean value reported)
Change From Baseline to Week 24 in Actigraphy DLPA for Variables Expressed in Counts
Change from baseline to Week 24 of the DLPA activity parameters for volume of non-sedentary activity (Koster '16)were reported. These variables were assessed by actigraphy and were expressed in counts. Koster 2016 defined the threshold between sedentary and NSA based on wrist-worn accelerometers on non-dominant hand, respectively. Positive change from baseline means improvement.
Measured: Baseline and Week 24 (data analysis was done during 14-Days each for Baseline and for Week 24 and mean value reported)
Change From Baseline to Week 24 in Actigraphy DLPA for Variable Expressed in Step Counts
Change from baseline to Week 24 of the DLPA activity parameters for number of steps during awake time were reported. These variables were assessed by actigraphy and were expressed in step counts. Positive change from baseline means improvement.
Measured: Baseline and Week 24 (data analysis was done during 14-Days each for Baseline and for Week 24 and mean value reported)
Change From Baseline to Week 24 in Actigraphy DLPA for Variables Expressed in Step Counts/Minute
Change from baseline to Week 24 of the DLPA activity parameters for number of steps during awake time were reported. These variables were assessed by actigraphy and were expressed in step counts/minute. Positive change from baseline means improvement.
Measured: Baseline and Week 24 (data analysis was done during 14-Days each for Baseline and for Week 24 and mean value reported)
Change From Baseline to Week 24 in Total Sleep Time (TST)
TST (in minutes) was assessed by actigraphy.
Measured: Baseline and Week 24 (data analysis was done during 14-Days each for Baseline and for Week 24 and mean value reported)
Change From Baseline to Week 24 in Wake After Sleep Onset (WASO)
WASO (in minutes) was assessed by actigraphy.
Measured: Baseline and Week 24 (data collection was done during 14-Days each for Baseline and for Week 24)
Change From Baseline to Week 24 in Number of Awakenings
Number of awakenings was assessed by actigraphy.
Measured: Baseline and Week 24 (data collection was done during 14-Days each for Baseline and for Week 24)
Change From Baseline to Week 24 in Sleep Efficiency (SE)
SE (in percentage) was assessed by actigraphy. Sleep efficiency was defined as the TST divided by the time in bed (minutes) multiplied by 100. TST was the duration in minutes including REM sleep plus NREM sleep during the time spent in bed.
Measured: Baseline and Week 24 (data collection was done during 14-Days each for Baseline and for Week 24)
Secondary outcomes (5)
Change From Baseline to Week 24 in Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Score
PAH-SYMPACT has 2 main parts: symptoms (cardiopulmonary and cardiovascular) and impact (physical impacts and cognitive/emotional). The symptom part is a questionnaire completed daily for 7 consecutive days and contains 11 items. The impact part has a 7-day recall period and is completed on 7th day of symptoms questionnaire data collection period. It contains 11 items pertaining to impact of PAH. The average Cardiopulmonary Symptoms and cardiovascular symptoms domain scores are determined based on daily scores of 6 and 5 items, respectively, reported on a 5-point Likert scale with score range from 0=best to 4=worst. The Physical impacts and Cognitive/emotional domain consists of 7 items reported on a 5-point Likert scale (from 0 to 4). The value 0 = "not at all"/"with no difficulty at all" and value 4 = "very much"/"extremely"/ "not able at all". Mean value on each of 7-day period was calculated for each specific domain score and corresponding mean change from baseline was reported.
Measured: Baseline and Week 24
Number of Participants With Change From Baseline to Week 24 in World Health Organization Functional Class (WHO FC)
The WHO FC of pulmonary hypertension is a physical activity rating scale as follows: Class I (No limitation of physical activity); Class II (Slight limitation of physical activity); Class III (Marked limitation of physical activity); and Class IV (Inability to carry out any physical activity without symptoms). The change from baseline in WHO FC was classified into "Improved", "No change" and "Worsened" compared to baseline. Deterioration, No Change, and Improvement are based on shift of risk category (I, II, III, IV) from baseline in WHO Functional Class.
Measured: Baseline and Week 24
Change From Baseline to Week 24 in 6-Minute Walk Distance (6MWD)
The 6MWD was the total distance walked during 6 minutes. Mean change from baseline (distance walked at Week 24 minus distance walked at baseline) was reported.
Measured: Baseline and Week 24
Change From Baseline to Week 24 in Borg Dyspnea Score
The Borg dyspneas score was a self-rating scale to evaluate the severity of dyspnea (from 0 "no shortness of breath at all" to 10 "very, very severe / maximal") shortness of breath. It was completed immediately after the 6-minute walk test at Week 24 and at baseline. Mean change from baseline in scoring was reported.
Measured: Baseline and Week 24
Change From Baseline to Week 24 in N-Terminal Pro B-type Natriuretic Peptide (NT-proBNP)
Change from baseline to Week 24 in NT-pro BNP levels was reported. The negative change from baseline means improvement.
Measured: Baseline and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study start8 Nov 2017
- Primary completion10 Feb 2020
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Pfister, Study director, Actelion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03078907
- Sponsor's protocol ID
- AC-065A404
- Acronym
- TRACE
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2017
- Last updated
- 30 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Rehman RZU, Parisi F, Ashraf N, Chatterjee M, Frantz RP, Hemnes AR, Manyakov NV, Carrasco-Zevallos OM, Yardibi T, Selej M, Mansi T, Dunnmon P, Kaliukhovich DA. Characteristics of Daily Walking Bouts as Valid and Reliable Indicators of Exercise Capacity in Pulmonary Arterial Hypertension: Insights From the Randomized Controlled Study With Selexipag (TRACE). Pulm Circ. 2025 May 26;15(2):e70097. doi: 10.1002/pul2.70097. eCollection 2025 Apr.
PubMed 40433632Howard LS, Rosenkranz S, Frantz RP, Hemnes AR, Pfister T, Hsu Schmitz SF, Skara H, Humbert M, Preston IR. Assessing Daily Life Physical Activity by Actigraphy in Pulmonary Arterial Hypertension: Insights From the Randomized Controlled Study With Selexipag (TRACE). Chest. 2023 Feb;163(2):407-418. doi: 10.1016/j.chest.2022.08.2231. Epub 2022 Sep 8.
PubMed 36089068
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03078907
- Acronym / sponsor ID
- TRACE / AC-065A404
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- daily life, physical activity, actigraphy, PAH-SYMPACT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 14 Mar 2017 (actual)
- Results
- Posted 23 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selexipag | Experimental | Drug: SelexipagSelexipag 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. |
| Placebo | Placebo comparator | Drug: PlaceboRegimen and titration scheme similar to those in the selexipag group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
- With the following hemodynamic characteristics assessed by right heart catheterization (RHC) prior to randomization:
- Treatment with an endothelin receptor antagonist (ERA) for at least 90 days and on a stable dose for 30 days prior to randomization.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SelexipagAlso: ACT-293987, UptraviFilm-coated tablets for oral use; one tablet (200 mcg) to eight tablets (1600 mcg) are administered depending on the individual tolerability. | Drug | Selexipag |
| PlaceboMatching film coated tablets | Drug | Placebo |
Primary outcome
Change From Baseline to Week 24 in Actigraphy Assessed Daily Life Physical Activity (DLPA) for Variables Expressed in Minutes
Time frame: Baseline and Week 24 (data analysis was done during 14-Days each for Baseline and for Week 24 and mean value reported)
Change from baseline to Week 24 of the DLPA activity parameters for daily time spent in non-sedentary activity (NSA) (as defined by Freedson '98 and Koster '16) and daily time spent in moderate-to-vigorous physical activity (MVPA) as defined by Freedson '98 were reported. These variables were assessed by actigraphy and were expressed in minutes. Freedson 1998 established ranges of activity counts obtained from a hip worn accelerometer corresponding to commonly employed MET categories. Based on this work, threshold between sedentary and NSA was defined. This threshold is often referred to as Freedson's 1998 publication. Koster 2016 defined the threshold between sedentary and NSA based on wrist-worn accelerometers on non-dominant hand, respectively. Positive change from baseline means improvement.
Change From Baseline to Week 24 in Actigraphy DLPA for Variables Expressed in Percentage (%)
Time frame: Baseline and Week 24 (data analysis was done during 14-Days each for Baseline and for Week 24 and mean value reported)
Change from baseline to Week 24 of the DLPA activity parameters for daily time spent in non-sedentary activity (NSA) (Freedson '98), daily time spent in moderate-to-vigorous physical activity (MVPA) (Freedson '98) and dailytime spent in NSA (Koster '16) were reported. These variables were assessed by actigraphy and were expressed in percentage (%). Freedson 1998 established ranges of activity counts obtained from a hip worn accelerometer corresponding to commonly employed MET categories. Based on this work, threshold between sedentary and NSA was defined. This threshold is often referred to as Freedson's 1998 publication. Koster 2016 defined the threshold between sedentary and NSA based on wrist-worn accelerometers on non-dominant hand, respectively. Positive change from baseline means improvement.
Change From Baseline to Week 24 in Actigraphy DLPA for Variables Expressed in Counts Per Minute (Counts/Minute)
Time frame: Baseline and Week 24 (data analysis was done during 14-Days each for Baseline and for Week 24 and mean value reported)
Change from baseline to Week 24 of the DLPA activity parameter for total daily activities and NSA (Koster '16) were reported. These variables were assessed by actigraphy and were expressed in counts/minutes. Koster 2016 defined the threshold between sedentary and NSA based on wrist-worn accelerometers on non-dominant hand, respectively. Positive change from baseline means improvement.
Change From Baseline to Week 24 in Actigraphy DLPA for Variables Expressed in Counts
Time frame: Baseline and Week 24 (data analysis was done during 14-Days each for Baseline and for Week 24 and mean value reported)
Change from baseline to Week 24 of the DLPA activity parameters for volume of non-sedentary activity (Koster '16)were reported. These variables were assessed by actigraphy and were expressed in counts. Koster 2016 defined the threshold between sedentary and NSA based on wrist-worn accelerometers on non-dominant hand, respectively. Positive change from baseline means improvement.
Change From Baseline to Week 24 in Actigraphy DLPA for Variable Expressed in Step Counts
Time frame: Baseline and Week 24 (data analysis was done during 14-Days each for Baseline and for Week 24 and mean value reported)
Change from baseline to Week 24 of the DLPA activity parameters for number of steps during awake time were reported. These variables were assessed by actigraphy and were expressed in step counts. Positive change from baseline means improvement.
Change From Baseline to Week 24 in Actigraphy DLPA for Variables Expressed in Step Counts/Minute
Time frame: Baseline and Week 24 (data analysis was done during 14-Days each for Baseline and for Week 24 and mean value reported)
Change from baseline to Week 24 of the DLPA activity parameters for number of steps during awake time were reported. These variables were assessed by actigraphy and were expressed in step counts/minute. Positive change from baseline means improvement.
Change From Baseline to Week 24 in Total Sleep Time (TST)
Time frame: Baseline and Week 24 (data analysis was done during 14-Days each for Baseline and for Week 24 and mean value reported)
TST (in minutes) was assessed by actigraphy.
Change From Baseline to Week 24 in Wake After Sleep Onset (WASO)
Time frame: Baseline and Week 24 (data collection was done during 14-Days each for Baseline and for Week 24)
WASO (in minutes) was assessed by actigraphy.
Change From Baseline to Week 24 in Number of Awakenings
Time frame: Baseline and Week 24 (data collection was done during 14-Days each for Baseline and for Week 24)
Number of awakenings was assessed by actigraphy.
Change From Baseline to Week 24 in Sleep Efficiency (SE)
Time frame: Baseline and Week 24 (data collection was done during 14-Days each for Baseline and for Week 24)
SE (in percentage) was assessed by actigraphy. Sleep efficiency was defined as the TST divided by the time in bed (minutes) multiplied by 100. TST was the duration in minutes including REM sleep plus NREM sleep during the time spent in bed.
5 secondary outcomes
Change From Baseline to Week 24 in Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Score
Time frame: Baseline and Week 24
Number of Participants With Change From Baseline to Week 24 in World Health Organization Functional Class (WHO FC)
Time frame: Baseline and Week 24
Change From Baseline to Week 24 in 6-Minute Walk Distance (6MWD)
Time frame: Baseline and Week 24
Change From Baseline to Week 24 in Borg Dyspnea Score
Time frame: Baseline and Week 24
Change From Baseline to Week 24 in N-Terminal Pro B-type Natriuretic Peptide (NT-proBNP)
Time frame: Baseline and Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40433632Rehman RZU, Parisi F, Ashraf N, Chatterjee M, Frantz RP, Hemnes AR, Manyakov NV, Carrasco-Zevallos OM, Yardibi T, Selej M, Mansi T, Dunnmon P, Kaliukhovich DA. Characteristics of Daily Walking Bouts as Valid and Reliable Indicators of Exercise Capacity in Pulmonary Arterial Hypertension: Insights From the Randomized Controlled Study With Selexipag (TRACE). Pulm Circ. 2025 May 26;15(2):e70097. doi: 10.1002/pul2.70097. eCollection 2025 Apr.
- Derived from this study: PubMed 36089068Howard LS, Rosenkranz S, Frantz RP, Hemnes AR, Pfister T, Hsu Schmitz SF, Skara H, Humbert M, Preston IR. Assessing Daily Life Physical Activity by Actigraphy in Pulmonary Arterial Hypertension: Insights From the Randomized Controlled Study With Selexipag (TRACE). Chest. 2023 Feb;163(2):407-418. doi: 10.1016/j.chest.2022.08.2231. Epub 2022 Sep 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Pfister study director
Actelion
39 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Selexipag in people with Pulmonary Arterial Hypertension, run by Actelion at 39 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, United Kingdom, Germany, France, Austria and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to Week 24 in Actigraphy Assessed Daily Life Physical Activity (DLPA) for Variables Expressed in Minutes (time frame: Baseline and Week 24 (data analysis was done during 14-Days each for Baseline and for Week 24 and mean value reported)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03078907, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.