drugset / Trial / NCT03078907
Effect of Selexipag on Daily Life Physical Activity of Patients With Pulmonary Arterial Hypertension.
RandomizedParallel-groupQuadruple-blindOther
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.
Timeline
- Start
- 2017-11-08
- Primary completion
- 2020-02-10
- Completion
- 2020-02-10
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.
- Howard 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Selexipag | Small molecule | 200 ug | Oral |
| Subject | Selexipag | Small molecule | 400 ug | Oral |
| Subject | Selexipag | Small molecule | 600 ug | Oral |
| Subject | Selexipag | Small molecule | 800 ug | Oral |
| Subject | Selexipag | Small molecule | 1000 ug | Oral |
| Subject | Selexipag | Small molecule | 1200 ug | Oral |
| Subject | Selexipag | Small molecule | 1400 ug | Oral |
| Subject | Selexipag | Small molecule | 1600 ug | Oral |