Daily life physical activity and disease symptoms assessed in patients with pulmonary arterial hypertension (PAH) treated with selexipag

• Register: EUCTR
• Last refreshed on: 20 April 2020
• Main ID: EUCTR2017-000216-42-IE
• Date of registration: 05/05/2017
• Prospective Registration: Yes
• Primary sponsor: Actelion Pharmaceuticals Ltd
• Public title: Daily life physical activity and disease symptoms assessed in patients with pulmonary arterial hypertension (PAH) treated with selexipag
• Scientific title: A multi-center, double-blind, placebo-controlled, Phase 3b 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 - TRACE
• Date of first enrolment: 12/09/2017
• Target sample size: 100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-000216-42
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Austria, France, Germany, Ireland, Netherlands, Norway, Portugal, Sweden, Switzerland, United Kingdom, United States

Contacts

• Name: Global Medical Affairs
• Affiliation: Actelion Pharmaceuticals Ltd

• Name: Global Medical Affairs
• Affiliation: Actelion Pharmaceuticals Ltd

Key inclusion & exclusion 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 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.
- Possible treatment with a Phosphodiesterase-5 inhibitor or sGC
stimulator 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®.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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 at any time prior to Day 1.
- Any hospitalization during the last 30 days prior to screening (Visit 1).
- Severe coronary heart disease or unstable angina.
- Documented severe hepatic impairment or severe renal insufficiency at screening (Visit 1).
- 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Pulmonary arterial hypertension
MedDRA version: 20.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Intervention(s)

Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Selexipag
Current Sponsor code: ACT-293987
Other descriptive name: SELEXIPAG
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Up to Week 24

Secondary Objective: • To evaluate the effect of selexipag on PAH symptoms and their impacts in patients’ daily life.
• To evaluate the effect of selexipag on exercise capacity, and disease severity in patients with PAH.
• To evaluate the safety and tolerability of selexipag in patients with PAH.

Main Objective: To evaluate the effect of selexipag on daily life physical activity (DLPA)
of patients with pulmonary arterial hypertension (PAH) as assessed by a
wearable actigraphy device.

Primary end point(s): - Change from baseline to Week 24 / EOT in actigraphy-assessed daily life physical activity (DLPA) as measured by:
. Daily time spent (minutes) in non-sedentary activity
(> 100 activity counts per minute)
. Percentage of daily time spent in non-sedentary activity (> 100 activity counts per minute)
. Total DLPA in counts/min
. Sleep variables: Total sleep time (minutes); wake after sleep onset (minutes); number of awakenings, sleep efficiency (percentage)

Secondary Outcome(s)

Secondary end point(s): - Change from baseline to Week 24 / EOT for following PAH SYMPACT® domain scores:
. Cardiovascular symptom domain score
. Cardiopulmonary symptom domain score
. Physical impact domain score
. Cognitive/emotional impact domain score

- Change from baseline to Week 24 / EOT for following variables:
. WHO FC
. 6MWD
. Borg dyspnea index at 6MWT
. N-terminal pro b-type natriuretic peptide (NT-proBNP)

Timepoint(s) of evaluation of this end point: Up to Week 24

Secondary ID(s)

AC-065A404

2017-000216-42-GB

Source(s) of Monetary Support

Actelion Pharmaceuticals Ltd.

Ethics review

Status: Approved
Approval date: 12/09/2017
Contact: