Phase 4
N=108
Effect of Selexipag on Daily Life Physical Activity of Patients With Pulmonary Arterial Hypertension.
Pulmonary Arterial Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT03078907 ↗Enrolled (actual)
108
Serious AEs
8.3%
Results posted
Feb 2021
Primary outcome: Primary: Change From Baseline to Week 24 in Actigraphy Assessed Daily Life Physical Activity (DLPA) for Variables Expressed in Minutes — -15.2; -25.2; 0.2; -1.9 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Selexipag (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Actelion
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 24 in Actigraphy Assessed Daily Life Physical Activity (DLPA) for Variables Expressed in Minutes |
-15.2; -25.2; 0.2; -1.9; -0.7; -15.0 | — |
| PRIMARY Change From Baseline to Week 24 in Actigraphy DLPA for Variables Expressed in Percentage (%) |
0.08; -0.10; 0.23; 0.32; 0.80; 0.00 | — |
| PRIMARY Change From Baseline to Week 24 in Actigraphy DLPA for Variables Expressed in Counts Per Minute (Counts/Minute) |
29.3; 18.8; 36.1; 16.8 | — |
| PRIMARY Change From Baseline to Week 24 in Actigraphy DLPA for Variables Expressed in Counts |
3898; -49187 | — |
| PRIMARY Change From Baseline to Week 24 in Actigraphy DLPA for Variable Expressed in Step Counts |
-32.4; -170.9 | — |
| PRIMARY Change From Baseline to Week 24 in Actigraphy DLPA for Variables Expressed in Step Counts/Minute |
0.0; 0.0 | — |
| PRIMARY Change From Baseline to Week 24 in Total Sleep Time (TST) |
— | — |
| PRIMARY Change From Baseline to Week 24 in Wake After Sleep Onset (WASO) |
— | — |
| PRIMARY Change From Baseline to Week 24 in Number of Awakenings |
— | — |
| PRIMARY Change From Baseline to Week 24 in Sleep Efficiency (SE) |
— | — |
| SECONDARY Change From Baseline to Week 24 in Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Score |
-0.030; -0.080; 0.010; -0.045; -0.043; -0.074 | — |
| SECONDARY Number of Participants With Change From Baseline to Week 24 in World Health Organization Functional Class (WHO FC) |
2; 1; 33; 43; 9; 10 | — |
| SECONDARY Change From Baseline to Week 24 in 6-Minute Walk Distance (6MWD) |
18.3; 9.8 | — |
| SECONDARY Change From Baseline to Week 24 in Borg Dyspnea Score |
-0.25; 0.37 | — |
| SECONDARY Change From Baseline to Week 24 in N-Terminal Pro B-type Natriuretic Peptide (NT-proBNP) |
-153.8; 81.8 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03078907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.